ID

22348

Description

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Keywords

  1. 5/29/17 5/29/17 -
  2. 5/30/17 5/30/17 -
  3. 5/31/17 5/31/17 -
  4. 6/7/17 6/7/17 -
  5. 6/8/17 6/8/17 -
Uploaded on

May 31, 2017

DOI

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License

Creative Commons BY-NC 3.0

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DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Description

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)

In what language will the patient-reported outcome questionnaires be administered (VFQ-25)?
Description

PT_LANGUAGE_USED [PTLANG]

Data type

integer

Alias
UMLS CUI [1]
C0023008
VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0)
Description

VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0)

Date Administered:
Description

ADMINISTRATION_DT [ADDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C1302393
DD/MMM/YY
1. In general, would you say your overall health is:
Description

LINE_NUMBER [LN1]

Data type

integer

Alias
UMLS CUI [1]
C3174572
2. At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?
Description

LINE_NUMBER [LN2]

Data type

integer

Alias
UMLS CUI [1]
C3174874
3. How much of the time do you worry about your eyesight?
Description

LINE_NUMBER [LN3]

Data type

integer

Alias
UMLS CUI [1]
C3174914
4. How much pain or discomfort have you had in and around your eyes (for example, burning, itching, or aching)? Would you say it is:
Description

LINE_NUMBER [LN4]

Data type

integer

Alias
UMLS CUI [1]
C3174916
5. How much difficulty do you have reading ordinary print in newspapers? Would you say you have:
Description

PART 2 - DIFFICULTY WITH ACTIVITIES The next questions are about how much difficulty, if any, you have doing certain activities wearing your glasses or contact lenses if you use them for that activity.

Data type

integer

Alias
UMLS CUI [1]
C3174916
6. How much difficulty do you have doing work or hobbies that require you to see well up close, such as cooking, sewing, fixing things around the house, or using hand tools? Would you say:
Description

LINE_NUMBER [LN6]

Data type

integer

Alias
UMLS CUI [1,1]
C3176685
7. Because of your eyesight, how much difficulty do you have finding something on a crowded shelf?
Description

LINE_NUMBER [LN7]

Data type

integer

Alias
UMLS CUI [1]
C3176687
7a. Wearing glasses, how much difficulty do you have reading the small print in a telephone book, on a medicine bottle, or on legal forms? Would you say:
Description

LINE_NUMBER [LN7a]

Data type

integer

Alias
UMLS CUI [1]
C3166557
7b. Because of your eyesight, how much difficulty do you have figuring out whether bills you receive are accurate?
Description

LINE_NUMBER [LN7b]

Data type

integer

Alias
UMLS CUI [1]
C3176641
7c. Because of your eyesight, how much difficulty do you have doing things like shaving, styling your hair, or putting on makeup?
Description

LINE_NUMBER [LN7c]

Data type

integer

Alias
UMLS CUI [1]
C3176643
8. How much difficulty do you have reading street signs or the names of stores?
Description

LINE_NUMBER [LN8]

Data type

integer

Alias
UMLS CUI [1,1]
C3176689
9. Because of your eyesight, how much difficulty do you have going down steps, stairs, or curbs in dim light or at night?
Description

LINE_NUMBER [LN9]

Data type

integer

Alias
UMLS CUI [1]
C3176691
10. Because of your eyesight, how much difficulty do you have noticing objects off to the side while you are walking along?
Description

LINE_NUMBER [LN10]

Data type

integer

Alias
UMLS CUI [1]
C3176693
10a. Because of your eyesight, how much difficulty do you have recognizing people you know from across a room?
Description

LINE_NUMBER [LN10a]

Data type

integer

Alias
UMLS CUI [1,1]
C3176645
10b. Because of your eyesight, how much difficulty do you have taking part in active sports or other outdoor activities that you enjoy (like golf, bowling, jogging, or walking)?
Description

LINE_NUMBER [LN10b]

Data type

integer

Alias
UMLS CUI [1]
C3176647
10c. Because of your eyesight, how much difficulty do you have seeing and enjoying programs on TV?
Description

LINE_NUMBER [LN10c]

Data type

integer

Alias
UMLS CUI [1,1]
C3176649
11. Because of your eyesight, how much difficulty do you have seeing how people react to things you say?
Description

LINE_NUMBER [LN11]

Data type

integer

Alias
UMLS CUI [1]
C3176695
12. Because of your eyesight, how much difficulty do you have picking out and matching your own clothes?
Description

LINE_NUMBER [LN12]

Data type

integer

Alias
UMLS CUI [1]
C3176697
13. Because of your eyesight, how much difficulty do you have visiting with people in their homes, at parties, or in restaurants?
Description

LINE_NUMBER [LN13]

Data type

integer

Alias
UMLS CUI [1,1]
C3176699
14. Because of your eyesight, how much difficulty do you have going out to see movies, plays or sports events?
Description

LINE_NUMBER [LN14]

Data type

integer

Alias
UMLS CUI [1]
C3176701
15. Now, I’d like to ask about driving a car. Are you currently driving, at least once in a while?
Description

LINE_NUMBER [LN15]

Data type

integer

Alias
UMLS CUI [1]
C3174918
15a. If NO, ASK: Have you never driven a car or have you given up driving?
Description

LINE_NUMBER [LN15a]

Data type

integer

Alias
UMLS CUI [1,1]
C3174287
IF GAVE UP DRIVING: Was that mainly because of your eyesight, mainly for some other reason, or because of both your eyesight and other reasons?
Description

LINE_NUMBER [LN15b]

Data type

integer

Alias
UMLS CUI [1,1]
C3166530
15c. IF CURRENTLY DRIVING: How much difficulty do you have driving during the daytime in familiar places? Would you say you have:
Description

LINE_NUMBER [LN15c]

Data type

integer

Alias
UMLS CUI [1,1]
C3174290
16. How much difficulty do you have driving at night? Would you say you have:
Description

LINE_NUMBER [LN16]

Data type

integer

Alias
UMLS CUI [1,1]
C3174292
16a. How much difficulty do you have driving in difficult conditions, such as in bad weather, during rush hour, on the freeway, or in city traffic? Would you say you have:
Description

LINE_NUMBER [LN16a]

Data type

integer

Alias
UMLS CUI [1,1]
C3174294
17. Do you accomplish less than you would like because of your vision?
Description

PART 3 - RESPONSES TO VISION PROBLEMS The next questions are about how things you do may be affected by your vision. For each one, I’d like you to tell me if this is true for you all, most, some, a little, or none of the time.

Data type

integer

Alias
UMLS CUI [1]
C3174296
18. Are you limited in how long you can work or do other activities because of your vision?
Description

LINE_NUMBER [LN18]

Data type

integer

Alias
UMLS CUI [1,1]
C3174298
19. How much does pain or discomfort in or around your eyes, for example, burning, itching, or aching, keep you from doing what you’d like to be doing? Would you say:
Description

LINE_NUMBER [LN19]

Data type

integer

Alias
UMLS CUI [1]
C3174920
20. I stay home most of the time because of my eyesight...
Description

For each of the following statements, please tell me if it is definitely true, mostly true, mostly false, or definitely false for you or you are not sure. (Circle one on each line)

Data type

integer

Alias
UMLS CUI [1]
C3176629
21. I feel frustrated a lot of the time because of my eyesight...
Description

LINE_NUMBER [LN21]

Data type

integer

Alias
UMLS CUI [1]
C3176631
22. I have much less control over what I do, because of my eyesight...
Description

LINE_NUMBER [LN22]

Data type

integer

Alias
UMLS CUI [1,1]
C3176633
23. Because of my eyesight, I have to rely too much on what other people tell me...
Description

LINE_NUMBER [LN23]

Data type

integer

Alias
UMLS CUI [1]
C3176633
24. I need a lot of help from others because of my eyesight...
Description

LINE_NUMBER [LN24]

Data type

integer

Alias
UMLS CUI [1]
C3176637
25. I worry about doing things that will embarrass myself or others, because of my eyesight...
Description

LINE_NUMBER [LN25]

Data type

integer

Alias
UMLS CUI [1,1]
C3176639
PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Description

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)

In what language will the patient-reported outcome questionnaires be administered (RetDQoL)?
Description

PT_LANGUAGE_USED [PTLANG]

Data type

integer

Alias
UMLS CUI [1]
C0023008
RetDQoL (DAY 0)
Description

RetDQoL (DAY 0)

I) In general, my present quality of life is:
Description

This questionnaire asks about your quality of life - in other words, how good or bad you feel your life is. Please put an “X” in the box that best indicates your response for each item. What we want to know is how you feel about your life now.

Data type

integer

II) If I did not have diabetic eye problems, my quality of life would be:
Description

Now we would like to know how your quality of life is affected by your diabetic eye problems - the eye problems often caused by diabetes. We want you to think about your diabetic eye problems, not your diabetes itself.

Data type

integer

1a) If I did not have diabetic eye problems, I could handle my household tasks:
Description

Please respond to the more specific items on the pages that follow. For each aspect of life described, you will find two parts: For part (a) put an “X” in one box to show how diabetic eye problems affect this aspect of your life. For part (b) put an “X” in one box to show how important this aspect of your life is to your quality of life.

Data type

integer

1b) Handling my household tasks is:
Description

FACT_QUESTION_NUMBER [FACQN4]

Data type

integer

2a) If I did not have diabetic eye problems, I could handle my personal affairs (letters, bills, etc.):
Description

FACT_QUESTION_NUMBER [FACQN5]

Data type

integer

2b) Handling my personal affairs is:
Description

FACT_QUESTION_NUMBER [FACQN6]

Data type

integer

3a) If I did not have diabetic eye problems, my experience of shopping would be:
Description

FACT_QUESTION_NUMBER [FACQN7]

Data type

integer

3b) My experience of shopping is:
Description

FACT_QUESTION_NUMBER [FACQN8]

Data type

integer

4a) If I did not have diabetic eye problems, my feelings about the future (e.g., worries, hopes) would be:
Description

FACT_QUESTION_NUMBER [FACQN9]

Data type

integer

4b) My feelings about the future are:
Description

FACT_QUESTION_NUMBER [FACQN10]

Data type

integer

5a) If I did not have diabetic eye problems, my feelings about past medical care and / or self-care (e.g., anger or regret): would be:
Description

FACT_QUESTION_NUMBER [FACQN11]

Data type

integer

5b) My feelings about the past are:
Description

FACT_QUESTION_NUMBER [FACQN12]

Data type

integer

6) Are you currently working, looking for work or would you like to work?
Description

If No, please skip to question 7. If Yes, please complete this page.

Data type

integer

6a) If I did not have diabetic eye problems, my work life would be:
Description

FACT_QUESTION_NUMBER [FACQN14]

Data type

integer

6b) For me, having a work life is:
Description

FACT_QUESTION_NUMBER [FACQN15]

Data type

integer

7) Do you have or would you like to have a close personal relationship (e.g., husband / wife, partner)?
Description

If No, please turn to the next page, question 8. If Yes, please complete this page.

Data type

integer

7a) If I did not have diabetic eye problems, my closest personal relationship would be:
Description

FACT_QUESTION_NUMBER [FACQN17]

Data type

integer

7b) For me, having a close personal relationship is:
Description

FACT_QUESTION_NUMBER [FACQN18]

Data type

integer

8) Do you have any family / relatives?
Description

If No, please skip to question 9a. If Yes, please complete this page.

Data type

integer

8a) If I did not have diabetic eye problems, my family life would be:
Description

FACT_QUESTION_NUMBER [FACQN20]

Data type

integer

8b) My family life is:
Description

FACT_QUESTION_NUMBER [FACQN21]

Data type

integer

9a) If I did not have diabetic eye problems, my friendships and social life would be:
Description

FACT_QUESTION_NUMBER [FACQN22]

Data type

integer

9b) My friendships and social life are:
Description

FACT_QUESTION_NUMBER [FACQN23]

Data type

integer

10a) If I did not have diabetic eye problems, I could do things for others as I wish:
Description

FACT_QUESTION_NUMBER [FACQN24]

Data type

integer

10b) For me, doing things for others is:
Description

FACT_QUESTION_NUMBER [FACQN25]

Data type

integer

11a) If I did not have diabetic eye problems, I could get out and about (e.g., on foot, or by car, bus or train):
Description

FACT_QUESTION_NUMBER [FACQN26]

Data type

integer

11b) For me, getting out and about is:
Description

FACT_QUESTION_NUMBER [FACQN27]

Data type

integer

12) Do you ever go on vacation or want to go on vacation?
Description

If No, please turn to the next page, question 13a. If Yes, please complete this page.

Data type

integer

12) Do you ever go on vacation or want to go on vacation?
Description

If No, please turn to the next page, question 13a. If Yes, please complete this page.

Data type

integer

12a) If I did not have diabetic eye problems, my vacations would be:
Description

FACT_QUESTION_NUMBER [FACQN29]

Data type

integer

12b) For me, vacations are:
Description

FACT_QUESTION_NUMBER [FACQN30]

Data type

integer

13a) If I did not have diabetic eye problems, my financial situation would be:
Description

FACT_QUESTION_NUMBER [FACQN31]

Data type

integer

13b) My financial situation is:
Description

FACT_QUESTION_NUMBER [FACQN32]

Data type

integer

14a) If I did not have diabetic eye problems, the way people in general react to me would be:
Description

FACT_QUESTION_NUMBER [FACQN33]

Data type

integer

14b) The way people in general react to me is:
Description

FACT_QUESTION_NUMBER [FACQN34]

Data type

integer

15a) If I did not have diabetic eye problems, my physical appearance (including clothes and grooming) would be:
Description

FACT_QUESTION_NUMBER [FACQN35]

Data type

integer

15b) My physical appearance is:
Description

FACT_QUESTION_NUMBER [FACQN36]

Data type

integer

16a) If I did not have diabetic eye problems, physically I could do:
Description

FACT_QUESTION_NUMBER [FACQN37]

Data type

integer

16b) For me, how much I can do physically is:
Description

FACT_QUESTION_NUMBER [FACQN38]

Data type

integer

17a) If I did not have diabetic eye problems, I could enjoy my leisure activities and interests (e.g., reading, TV, radio, hobbies):
Description

FACT_QUESTION_NUMBER [FACQN39]

Data type

integer

17b) My leisure activities are:
Description

FACT_QUESTION_NUMBER [FACQN40]

Data type

integer

18a) If I did not have diabetic eye problems, my self-confidence would be:
Description

FACT_QUESTION_NUMBER [FACQN41]

Data type

integer

18b) My self-confidence is:
Description

FACT_QUESTION_NUMBER [FACQN42]

Data type

integer

19a) If I did not have diabetic eye problems, my motivation would be:
Description

FACT_QUESTION_NUMBER [FACQN43]

Data type

integer

19b) My motivation is:
Description

FACT_QUESTION_NUMBER [FACQN44]

Data type

integer

20) Are there occasions when you wish you did not need to depend on other people?
Description

Whether you answered Yes or No, please complete this page.

Data type

integer

20a) If I did not have diabetic eye problems, I could do things independently:
Description

FACT_QUESTION_NUMBER [FACQN46]

Data type

integer

20b) For me, being able to do things independently is:
Description

FACT_QUESTION_NUMBER [FACQN47]

Data type

integer

21a) If I did not have diabetic eye problems, I would have mishaps or would lose things:
Description

FACT_QUESTION_NUMBER [FACQN48]

Data type

integer

21b) For me, not having mishaps or losing things is:
Description

FACT_QUESTION_NUMBER [FACQN49]

Data type

integer

22a) If I did not have diabetic eye problems, the time it takes me to do things would be:
Description

FACT_QUESTION_NUMBER [FACQN50]

Data type

integer

22b) The time it takes me to do things is:
Description

FACT_QUESTION_NUMBER [FACQN51]

Data type

integer

23a) If I did not have diabetic eye problems, I would find taking care of my diabetes (e.g., self-testing, medication, food, exercise):
Description

FACT_QUESTION_NUMBER [FACQN52]

Data type

integer

23b) Taking care of my diabetes is: exercise):
Description

FACT_QUESTION_NUMBER [FACQN53]

Data type

integer

24a) If I did not have diabetic eye problems, I could enjoy nature:
Description

FACT_QUESTION_NUMBER [FACQN54]

Data type

integer

24b) My enjoyment of nature is:
Description

FACT_QUESTION_NUMBER [FACQN55]

Data type

integer

25) Do your diabetic eye problems affect your quality of life in any ways that have not been covered by the questionnaire?
Description

If Yes, please describe in the box provided.

Data type

integer

Do your diabetic eye problems affect your quality of life in any ways that have not been covered by the questionnaire? If Yes, please describe in the box provided.
Description

OTHER_SPECIFY [OTHSP]

Data type

text

VITAL SIGNS (DAY 0)
Description

VITAL SIGNS (DAY 0)

Were any vital signs recorded at this visit?
Description

VITAL_SIGNS_RECORDS [VTLREC]

Data type

boolean

Alias
UMLS CUI [1]
C1740486
Vital Signs Date:
Description

VITAL_SIGNS_DT [VTLDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2826644
DD/MMM/YY
Vital Signs Time:
Description

VITAL_SIGNS_TIME [VTLTM]

Data type

time

Alias
UMLS CUI [1]
C2827042
Temp:
Description

TEMPERATURE [TEMP]

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Pulse:
Description

PULSE [PULSE]

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1]
C0232117
/min
Resp:
Description

RESPIRATION [RESP]

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1]
C0231832
/min
Blood Pressure sys:
Description

BLOOD_PRESSURE_SYS [BPS]

Data type

integer

Alias
UMLS CUI [1]
C0871470
Blood Pressure dys:
Description

BLOOD_PRESSURE_DIA [BPD]

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
CONTRAST SENSITIVITY (DAY 0)
Description

CONTRAST SENSITIVITY (DAY 0)

Testing Distance: 1 meter
Description

DISTANCE_CHAR [DSTCHR]

Data type

text

Alias
UMLS CUI [1]
C0429925
Test Date:
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0200150
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Right Eye: Not Done
Description

NOT_DONE [NOTDN]

Data type

boolean

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0229089
Total number correct =
Description

CORRECT_READING [COTRD]

Data type

integer

Alias
UMLS CUI [1,1]
C0846621
UMLS CUI [1,2]
C0229089
Total CS Score =
Description

[(Total number correct - 3) X 0.05]

Data type

float

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0449820
UMLS CUI [1,3]
C0229089
Left Eye: Not Done
Description

NOT_DONE [NOTDN]

Data type

boolean

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0229090
Total number correct =
Description

CORRECT_READING [COTRD]

Data type

integer

Alias
UMLS CUI [1,1]
C0846621
UMLS CUI [1,2]
C0229090
Total CS Score =
Description

[(Total number correct - 3) X 0.05]

Data type

float

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0449820
UMLS CUI [1,3]
C0229090
READING SPEED (DAY 0)
Description

READING SPEED (DAY 0)

Right Eye: Not Done
Description

NOT_DONE [NOTDN]

Data type

boolean

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0229089
Card # used:
Description

CARD_NUMBER [CARDNO]

Data type

integer

Alias
UMLS CUI [1,1]
C3275277
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0229089
1a. Time to Complete:
Description

READING_TIME [RDTM]

Data type

time

Measurement units
  • m:ss
Alias
UMLS CUI [1,1]
C1549507
UMLS CUI [1,2]
C0229089
m:ss
b. No. of words read CORRECTLY:
Description

CORRECT_READING [COTRD]

Data type

integer

Alias
UMLS CUI [1,1]
C0871221
UMLS CUI [1,2]
C0229089
Left Eye: Not Done
Description

NOT_DONE [NOTDN]

Data type

boolean

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0229090
Card # used:
Description

CARD_NUMBER [CARDNO]

Data type

integer

Alias
UMLS CUI [1,1]
C3275277
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0229090
1a. Time to Complete:
Description

READING_TIME [RDTM]

Data type

time

Measurement units
  • m:ss
Alias
UMLS CUI [1,1]
C1549507
UMLS CUI [1,2]
C0229090
m:ss
b. No. of words read CORRECTLY:
Description

CORRECT_READING [COTRD]

Data type

integer

Alias
UMLS CUI [1,1]
C0871221
UMLS CUI [1,2]
C0229090
INTRAOCULAR PRESSURE (DAY 0)
Description

INTRAOCULAR PRESSURE (DAY 0)

Pre-dose Right Eye
Description

INTRAOCULAR_PRESSURE [ IOP]

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229089
mmHg
Pre-dose Right Eye Not Done
Description

INTRAOCULAR_PRESSURE [ IOP]

Data type

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229089
Pre-dose Left Eye
Description

INTRAOCULAR_PRESSURE [ IOP]

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229090
mmHg
Pre-dose Left Eye Not Done
Description

INTRAOCULAR_PRESSURE [ IOP]

Data type

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229090
Predose Date
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0011008
DD/MMM/YY
Predose Actual Time
Description

EXAM_TIME [EXMTM]

Data type

time

Measurement units
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0040223
24 hr clock
Predose Method
Description

Method must be consistent for a subject throughout the study.

Data type

integer

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0871511
60 min post-dose Study Eye
Description

QV: STUDY EYE

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0681850
mmHg
60 min post-dose Study Eye Not Done
Description

QV: STUDY EYE

Data type

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0681850
60 min post-dose Date
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0011008
DD/MMM/YY
60 min post-dose Actual Time
Description

EXAM_TIME [EXMTM]

Data type

time

Measurement units
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0040223
24 hr clock
60 min post-dose Method
Description

Method must be consistent for a subject throughout the study.

Data type

integer

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0871511
SLITLAMP EXAMINATION (DAY 0)
Description

SLITLAMP EXAMINATION (DAY 0)

Date of Exam:
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Aqueous Cell
Description

SLIT_LAMP_AQ_CELL [SLAQC]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0003662
UMLS CUI [1,4]
C0229089
Aqueous Flare
Description

SLIT_LAMP_AQ_FLARE [SLAQF]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0524490
UMLS CUI [1,4]
C0229089
Vitreous Cell
Description

SLIT_LAMP_VIT_CELL [SLVITC]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0042905
UMLS CUI [1,4]
C0229089
Vitreous Hemorrhage
Description

SLIT_LAMP_VIT_HEM [SLHEM]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0042909
UMLS CUI [1,4]
C0229089
Cataracts Subcapsular
Description

SLIT_LAMP_CATA_SUB [SLCAS]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0235259
UMLS CUI [1,4]
C0229089
Cataracts Cortical
Description

SLIT_LAMP_CATA_CORT [SLCAC]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0271160
UMLS CUI [1,4]
C0229089
Cataracts Nuclear
Description

SLIT_LAMP_CATA_NUC [SLCAN]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0392557
UMLS CUI [1,4]
C0229089
Is artificial intraocular lens implant present?
Description

LENS_RESULT [LNSRES2]

Data type

boolean

Alias
UMLS CUI [1,1]
C0336564
UMLS CUI [1,2]
C0229089
Aqueous Cell
Description

SLIT_LAMP_AQ_CELL [SLAQC]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0003662
UMLS CUI [1,4]
C0229090
Aqueous Flare
Description

SLIT_LAMP_AQ_FLARE [SLAQF]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0524490
UMLS CUI [1,4]
C0229090
Vitreous Cell
Description

SLIT_LAMP_VIT_CELL [SLVITC]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0042905
UMLS CUI [1,4]
C0229090
Vitreous Hemorrhage
Description

SLIT_LAMP_VIT_HEM [SLHEM]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0042909
UMLS CUI [1,4]
C0229090
Cataracts Subcapsular
Description

SLIT_LAMP_CATA_SUB [SLCAS]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0235259
UMLS CUI [1,4]
C0229090
Cataracts Cortical
Description

SLIT_LAMP_CATA_CORT [SLCAC]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0271160
UMLS CUI [1,4]
C0229090
Cataracts Nuclear
Description

SLIT_LAMP_CATA_NUC [SLCAN]

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0392557
UMLS CUI [1,4]
C0229090
Is artificial intraocular lens implant present?
Description

LENS_RESULT [LNSRES2]

Data type

boolean

Alias
UMLS CUI [1,1]
C0336564
UMLS CUI [1,2]
C0229090
INDIRECT OPHTHALMOSCOPY (DAY 0) Right Eye
Description

INDIRECT OPHTHALMOSCOPY (DAY 0) Right Eye

Date of Exam:
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Clinically Significant Macular Edema (CSME) Present?
Description

MACULAR_EDEMA [MACEDM]

Data type

boolean

Alias
UMLS CUI [1,1]
C0271051
UMLS CUI [1,2]
C0229089
Neovascularization of the Disc (NVD)?
Description

OPHTHALMO_NEOV_DISC [OPHNVD]

Data type

boolean

Alias
UMLS CUI [1,1]
C1112634
UMLS CUI [1,2]
C0229089
Neovascularization (NVE) of the Retina elsewhere?
Description

OPHTHALMO_NVE [OPHNVE]

Data type

boolean

Alias
UMLS CUI [1,1]
C0035320
UMLS CUI [1,2]
C0229089
Neovascularization of the Iris?
Description

OPHTHALMO_NV_IRIS [OPHIRIS]

Data type

boolean

Alias
UMLS CUI [1,1]
C0271110
UMLS CUI [1,2]
C0229089
Posterior Vitreal Detachment (PVD)?
Description

IND_OPHT_VIT_DETACH [IODET]

Data type

boolean

Alias
UMLS CUI [1,1]
C0423361
UMLS CUI [1,2]
C0229089
Retinal Hemorrhages
Description

OPHTHALMO_RET_HEM [OPHEM]

Data type

integer

Alias
UMLS CUI [1,1]
C0035317
UMLS CUI [1,2]
C0229089
Cotton Wool Spots
Description

OPHTHALMO_COTTON [OPHCOT]

Data type

integer

Alias
UMLS CUI [1,1]
C0271053
UMLS CUI [1,2]
C0229089
Is there a new or worsened retinal break or detachment?
Description

OPHTHALMO_RET_BRK_DH [OPHBD]

Data type

boolean

Alias
UMLS CUI [1,1]
C0035321
UMLS CUI [1,2]
C0035305
UMLS CUI [1,3]
C0229089
INDIRECT OPHTHALMOSCOPY (DAY 0) Left Eye
Description

INDIRECT OPHTHALMOSCOPY (DAY 0) Left Eye

Date of Exam:
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Clinically Significant Macular Edema (CSME) Present?
Description

MACULAR_EDEMA [MACEDM]

Data type

boolean

Alias
UMLS CUI [1,1]
C0271051
UMLS CUI [1,2]
C0229090
Neovascularization of the Disc (NVD)?
Description

OPHTHALMO_NEOV_DISC [OPHNVD]

Data type

boolean

Alias
UMLS CUI [1,1]
C1112634
UMLS CUI [1,2]
C0229090
Neovascularization (NVE) of the Retina elsewhere?
Description

OPHTHALMO_NVE [OPHNVE]

Data type

boolean

Alias
UMLS CUI [1,1]
C0035320
UMLS CUI [1,2]
C0229090
Neovascularization of the Iris?
Description

OPHTHALMO_NV_IRIS [OPHIRIS]

Data type

boolean

Alias
UMLS CUI [1,1]
C0271110
UMLS CUI [1,2]
C0229090
Posterior Vitreal Detachment (PVD)?
Description

IND_OPHT_VIT_DETACH [IODET]

Data type

boolean

Alias
UMLS CUI [1,1]
C0423361
UMLS CUI [1,2]
C0229090
Retinal Hemorrhages
Description

OPHTHALMO_RET_HEM [OPHEM]

Data type

integer

Alias
UMLS CUI [1,1]
C0035317
UMLS CUI [1,2]
C0229090
Cotton Wool Spots
Description

OPHTHALMO_COTTON [OPHCOT]

Data type

integer

Alias
UMLS CUI [1,1]
C0271053
UMLS CUI [1,2]
C0229090
Is there a new or worsened retinal break or detachment?
Description

OPHTHALMO_RET_BRK_DH [OPHBD]

Data type

boolean

Alias
UMLS CUI [1,1]
C0035321
UMLS CUI [1,2]
C0035305
UMLS CUI [1,3]
C0229090

Similar models

DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Item
In what language will the patient-reported outcome questionnaires be administered (VFQ-25)?
integer
C0023008 (UMLS CUI [1])
Code List
In what language will the patient-reported outcome questionnaires be administered (VFQ-25)?
CL Item
English (1)
CL Item
Spanish (2)
Item Group
VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0)
ADMINISTRATION_DT [ADDT]
Item
Date Administered:
date
C1302393 (UMLS CUI [1])
Item
1. In general, would you say your overall health is:
integer
C3174572 (UMLS CUI [1])
Code List
1. In general, would you say your overall health is:
CL Item
1 - Excellent (1)
CL Item
2 - Very Good (2)
CL Item
3 - Good (3)
CL Item
4 - Fair (4)
CL Item
5 - Poor (5)
Item
2. At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?
integer
C3174874 (UMLS CUI [1])
Code List
2. At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?
CL Item
1 - Excellent (1)
CL Item
2 - Good (2)
CL Item
3 - Fair (3)
CL Item
4 - Poor (4)
CL Item
5 - Very poor (5)
CL Item
6 - Completely blind (6)
Item
3. How much of the time do you worry about your eyesight?
integer
C3174914 (UMLS CUI [1])
Code List
3. How much of the time do you worry about your eyesight?
CL Item
1 - None of the time (1)
CL Item
2 - A little of the time (2)
CL Item
3 - Some of the time (3)
CL Item
4 - Most of the time (4)
CL Item
5 - All of the time (5)
Item
4. How much pain or discomfort have you had in and around your eyes (for example, burning, itching, or aching)? Would you say it is:
integer
C3174916 (UMLS CUI [1])
Code List
4. How much pain or discomfort have you had in and around your eyes (for example, burning, itching, or aching)? Would you say it is:
CL Item
1 - None (1)
CL Item
2 - Mild (2)
CL Item
3 - Moderate (3)
CL Item
4 - Severe, or (4)
CL Item
5 - Very severe (5)
Item
5. How much difficulty do you have reading ordinary print in newspapers? Would you say you have:
integer
C3174916 (UMLS CUI [1])
Code List
5. How much difficulty do you have reading ordinary print in newspapers? Would you say you have:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
6. How much difficulty do you have doing work or hobbies that require you to see well up close, such as cooking, sewing, fixing things around the house, or using hand tools? Would you say:
integer
C3176685 (UMLS CUI [1,1])
Code List
6. How much difficulty do you have doing work or hobbies that require you to see well up close, such as cooking, sewing, fixing things around the house, or using hand tools? Would you say:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
7. Because of your eyesight, how much difficulty do you have finding something on a crowded shelf?
integer
C3176687 (UMLS CUI [1])
Code List
7. Because of your eyesight, how much difficulty do you have finding something on a crowded shelf?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
7a. Wearing glasses, how much difficulty do you have reading the small print in a telephone book, on a medicine bottle, or on legal forms? Would you say:
integer
C3166557 (UMLS CUI [1])
Code List
7a. Wearing glasses, how much difficulty do you have reading the small print in a telephone book, on a medicine bottle, or on legal forms? Would you say:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
7b. Because of your eyesight, how much difficulty do you have figuring out whether bills you receive are accurate?
integer
C3176641 (UMLS CUI [1])
Code List
7b. Because of your eyesight, how much difficulty do you have figuring out whether bills you receive are accurate?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
7c. Because of your eyesight, how much difficulty do you have doing things like shaving, styling your hair, or putting on makeup?
integer
C3176643 (UMLS CUI [1])
Code List
7c. Because of your eyesight, how much difficulty do you have doing things like shaving, styling your hair, or putting on makeup?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
8. How much difficulty do you have reading street signs or the names of stores?
integer
C3176689 (UMLS CUI [1,1])
Code List
8. How much difficulty do you have reading street signs or the names of stores?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
9. Because of your eyesight, how much difficulty do you have going down steps, stairs, or curbs in dim light or at night?
integer
C3176691 (UMLS CUI [1])
Code List
9. Because of your eyesight, how much difficulty do you have going down steps, stairs, or curbs in dim light or at night?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
10. Because of your eyesight, how much difficulty do you have noticing objects off to the side while you are walking along?
integer
C3176693 (UMLS CUI [1])
Code List
10. Because of your eyesight, how much difficulty do you have noticing objects off to the side while you are walking along?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
10a. Because of your eyesight, how much difficulty do you have recognizing people you know from across a room?
integer
C3176645 (UMLS CUI [1,1])
Code List
10a. Because of your eyesight, how much difficulty do you have recognizing people you know from across a room?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
10b. Because of your eyesight, how much difficulty do you have taking part in active sports or other outdoor activities that you enjoy (like golf, bowling, jogging, or walking)?
integer
C3176647 (UMLS CUI [1])
Code List
10b. Because of your eyesight, how much difficulty do you have taking part in active sports or other outdoor activities that you enjoy (like golf, bowling, jogging, or walking)?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
10c. Because of your eyesight, how much difficulty do you have seeing and enjoying programs on TV?
integer
C3176649 (UMLS CUI [1,1])
Code List
10c. Because of your eyesight, how much difficulty do you have seeing and enjoying programs on TV?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
11. Because of your eyesight, how much difficulty do you have seeing how people react to things you say?
integer
C3176695 (UMLS CUI [1])
Code List
11. Because of your eyesight, how much difficulty do you have seeing how people react to things you say?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
12. Because of your eyesight, how much difficulty do you have picking out and matching your own clothes?
integer
C3176697 (UMLS CUI [1])
Code List
12. Because of your eyesight, how much difficulty do you have picking out and matching your own clothes?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
13. Because of your eyesight, how much difficulty do you have visiting with people in their homes, at parties, or in restaurants?
integer
C3176699 (UMLS CUI [1,1])
Code List
13. Because of your eyesight, how much difficulty do you have visiting with people in their homes, at parties, or in restaurants?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
14. Because of your eyesight, how much difficulty do you have going out to see movies, plays or sports events?
integer
C3176701 (UMLS CUI [1])
Code List
14. Because of your eyesight, how much difficulty do you have going out to see movies, plays or sports events?
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
15. Now, I’d like to ask about driving a car. Are you currently driving, at least once in a while?
integer
C3174918 (UMLS CUI [1])
Code List
15. Now, I’d like to ask about driving a car. Are you currently driving, at least once in a while?
CL Item
Yes (Skip to Q15c) (1)
CL Item
No (2)
Item
15a. If NO, ASK: Have you never driven a car or have you given up driving?
integer
C3174287 (UMLS CUI [1,1])
Code List
15a. If NO, ASK: Have you never driven a car or have you given up driving?
CL Item
1 - Never drove (Skip to Part 3, Q17) (1)
CL Item
2 - Gave up (2)
Item
IF GAVE UP DRIVING: Was that mainly because of your eyesight, mainly for some other reason, or because of both your eyesight and other reasons?
integer
C3166530 (UMLS CUI [1,1])
Code List
IF GAVE UP DRIVING: Was that mainly because of your eyesight, mainly for some other reason, or because of both your eyesight and other reasons?
CL Item
1 - Mainly eyesight (1)
CL Item
(Skip to Part 3, Q17) (2)
CL Item
2 - Mainly other reasons (3)
CL Item
(Skip to Part 3, Q17) (4)
CL Item
3 - Both eyesight and other reasons (5)
CL Item
(Skip to Part 3, Q17) (6)
Item
15c. IF CURRENTLY DRIVING: How much difficulty do you have driving during the daytime in familiar places? Would you say you have:
integer
C3174290 (UMLS CUI [1,1])
Code List
15c. IF CURRENTLY DRIVING: How much difficulty do you have driving during the daytime in familiar places? Would you say you have:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
Item
16. How much difficulty do you have driving at night? Would you say you have:
integer
C3174292 (UMLS CUI [1,1])
Code List
16. How much difficulty do you have driving at night? Would you say you have:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
16a. How much difficulty do you have driving in difficult conditions, such as in bad weather, during rush hour, on the freeway, or in city traffic? Would you say you have:
integer
C3174294 (UMLS CUI [1,1])
Code List
16a. How much difficulty do you have driving in difficult conditions, such as in bad weather, during rush hour, on the freeway, or in city traffic? Would you say you have:
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
17. Do you accomplish less than you would like because of your vision?
integer
C3174296 (UMLS CUI [1])
Code List
17. Do you accomplish less than you would like because of your vision?
CL Item
1 - All of the time (1)
CL Item
2 - Most of the time (2)
CL Item
3 - Some of the time (3)
CL Item
4 - A little of the time (4)
CL Item
5 - None of the time (5)
Item
18. Are you limited in how long you can work or do other activities because of your vision?
integer
C3174298 (UMLS CUI [1,1])
Code List
18. Are you limited in how long you can work or do other activities because of your vision?
CL Item
1 - All of the time (1)
CL Item
2 - Most of the time (2)
CL Item
3 - Some of the time (3)
CL Item
4 - A little of the time (4)
CL Item
5 - None of the time (5)
Item
19. How much does pain or discomfort in or around your eyes, for example, burning, itching, or aching, keep you from doing what you’d like to be doing? Would you say:
integer
C3174920 (UMLS CUI [1])
Code List
19. How much does pain or discomfort in or around your eyes, for example, burning, itching, or aching, keep you from doing what you’d like to be doing? Would you say:
CL Item
1 - All of the time (1)
CL Item
2 - Most of the time (2)
CL Item
3 - Some of the time (3)
CL Item
4 - A little of the time (4)
CL Item
5 - None of the time (5)
Item
20. I stay home most of the time because of my eyesight...
integer
C3176629 (UMLS CUI [1])
Code List
20. I stay home most of the time because of my eyesight...
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
21. I feel frustrated a lot of the time because of my eyesight...
integer
C3176631 (UMLS CUI [1])
Code List
21. I feel frustrated a lot of the time because of my eyesight...
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
22. I have much less control over what I do, because of my eyesight...
integer
C3176633 (UMLS CUI [1,1])
Code List
22. I have much less control over what I do, because of my eyesight...
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
23. Because of my eyesight, I have to rely too much on what other people tell me...
integer
C3176633 (UMLS CUI [1])
Code List
23. Because of my eyesight, I have to rely too much on what other people tell me...
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
24. I need a lot of help from others because of my eyesight...
integer
C3176637 (UMLS CUI [1])
Code List
24. I need a lot of help from others because of my eyesight...
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item
25. I worry about doing things that will embarrass myself or others, because of my eyesight...
integer
C3176639 (UMLS CUI [1,1])
Code List
25. I worry about doing things that will embarrass myself or others, because of my eyesight...
CL Item
1 - Definitely True (1)
CL Item
2 - Mostly True (2)
CL Item
3 - Not Sure (3)
CL Item
4 - Mostly False (4)
CL Item
5 - Definitely False (5)
Item Group
PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Item
In what language will the patient-reported outcome questionnaires be administered (RetDQoL)?
integer
C0023008 (UMLS CUI [1])
Code List
In what language will the patient-reported outcome questionnaires be administered (RetDQoL)?
CL Item
English (1)
CL Item
Spanish (2)
Item Group
RetDQoL (DAY 0)
Item
I) In general, my present quality of life is:
integer
Code List
I) In general, my present quality of life is:
CL Item
Excellent  (1)
CL Item
Very Good  (2)
CL Item
Good  (3)
CL Item
Neither Good Nor Bad (4)
CL Item
Bad  (5)
CL Item
Very Bad  (6)
CL Item
Extremely Bad (7)
Item
II) If I did not have diabetic eye problems, my quality of life would be:
integer
Code List
II) If I did not have diabetic eye problems, my quality of life would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
1a) If I did not have diabetic eye problems, I could handle my household tasks:
integer
Code List
1a) If I did not have diabetic eye problems, I could handle my household tasks:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
1b) Handling my household tasks is:
integer
Code List
1b) Handling my household tasks is:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
2a) If I did not have diabetic eye problems, I could handle my personal affairs (letters, bills, etc.):
integer
Code List
2a) If I did not have diabetic eye problems, I could handle my personal affairs (letters, bills, etc.):
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
2b) Handling my personal affairs is:
integer
Code List
2b) Handling my personal affairs is:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
3a) If I did not have diabetic eye problems, my experience of shopping would be:
integer
Code List
3a) If I did not have diabetic eye problems, my experience of shopping would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
3b) My experience of shopping is:
integer
Code List
3b) My experience of shopping is:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
4a) If I did not have diabetic eye problems, my feelings about the future (e.g., worries, hopes) would be:
integer
Code List
4a) If I did not have diabetic eye problems, my feelings about the future (e.g., worries, hopes) would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
4b) My feelings about the future are:
integer
Code List
4b) My feelings about the future are:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
5a) If I did not have diabetic eye problems, my feelings about past medical care and / or self-care (e.g., anger or regret): would be:
integer
Code List
5a) If I did not have diabetic eye problems, my feelings about past medical care and / or self-care (e.g., anger or regret): would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
5b) My feelings about the past are:
integer
Code List
5b) My feelings about the past are:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
6) Are you currently working, looking for work or would you like to work?
integer
Code List
6) Are you currently working, looking for work or would you like to work?
CL Item
Yes (1)
CL Item
No (2)
Item
6a) If I did not have diabetic eye problems, my work life would be:
integer
Code List
6a) If I did not have diabetic eye problems, my work life would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
6b) For me, having a work life is:
integer
Code List
6b) For me, having a work life is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
7) Do you have or would you like to have a close personal relationship (e.g., husband / wife, partner)?
integer
Code List
7) Do you have or would you like to have a close personal relationship (e.g., husband / wife, partner)?
CL Item
Yes (1)
CL Item
No (2)
Item
7a) If I did not have diabetic eye problems, my closest personal relationship would be:
integer
Code List
7a) If I did not have diabetic eye problems, my closest personal relationship would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
7b) For me, having a close personal relationship is:
integer
Code List
7b) For me, having a close personal relationship is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
8) Do you have any family / relatives?
integer
Code List
8) Do you have any family / relatives?
CL Item
Yes (1)
CL Item
No (2)
Item
8a) If I did not have diabetic eye problems, my family life would be:
integer
Code List
8a) If I did not have diabetic eye problems, my family life would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
8b) My family life is:
integer
Code List
8b) My family life is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
9a) If I did not have diabetic eye problems, my friendships and social life would be:
integer
Code List
9a) If I did not have diabetic eye problems, my friendships and social life would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
9b) My friendships and social life are:
integer
Code List
9b) My friendships and social life are:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
10a) If I did not have diabetic eye problems, I could do things for others as I wish:
integer
Code List
10a) If I did not have diabetic eye problems, I could do things for others as I wish:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
10b) For me, doing things for others is:
integer
Code List
10b) For me, doing things for others is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
11a) If I did not have diabetic eye problems, I could get out and about (e.g., on foot, or by car, bus or train):
integer
Code List
11a) If I did not have diabetic eye problems, I could get out and about (e.g., on foot, or by car, bus or train):
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
11b) For me, getting out and about is:
integer
Code List
11b) For me, getting out and about is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
12) Do you ever go on vacation or want to go on vacation?
integer
Code List
12) Do you ever go on vacation or want to go on vacation?
CL Item
Yes (1)
CL Item
No (2)
Item
12) Do you ever go on vacation or want to go on vacation?
integer
Code List
12) Do you ever go on vacation or want to go on vacation?
CL Item
Yes (1)
CL Item
No (2)
Item
12a) If I did not have diabetic eye problems, my vacations would be:
integer
Code List
12a) If I did not have diabetic eye problems, my vacations would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
12b) For me, vacations are:
integer
Code List
12b) For me, vacations are:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
13a) If I did not have diabetic eye problems, my financial situation would be:
integer
Code List
13a) If I did not have diabetic eye problems, my financial situation would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
13b) My financial situation is:
integer
Code List
13b) My financial situation is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
14a) If I did not have diabetic eye problems, the way people in general react to me would be:
integer
Code List
14a) If I did not have diabetic eye problems, the way people in general react to me would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
14b) The way people in general react to me is:
integer
Code List
14b) The way people in general react to me is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
15a) If I did not have diabetic eye problems, my physical appearance (including clothes and grooming) would be:
integer
Code List
15a) If I did not have diabetic eye problems, my physical appearance (including clothes and grooming) would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
15b) My physical appearance is:
integer
Code List
15b) My physical appearance is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
16a) If I did not have diabetic eye problems, physically I could do:
integer
Code List
16a) If I did not have diabetic eye problems, physically I could do:
CL Item
Very Much More  (1)
CL Item
Much More  (2)
CL Item
A Little More  (3)
CL Item
The Same  (4)
CL Item
Less (5)
Item
16b) For me, how much I can do physically is:
integer
Code List
16b) For me, how much I can do physically is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
17a) If I did not have diabetic eye problems, I could enjoy my leisure activities and interests (e.g., reading, TV, radio, hobbies):
integer
Code List
17a) If I did not have diabetic eye problems, I could enjoy my leisure activities and interests (e.g., reading, TV, radio, hobbies):
CL Item
Very Much More  (1)
CL Item
Much More  (2)
CL Item
A Little More  (3)
CL Item
The Same  (4)
CL Item
Less (5)
Item
17b) My leisure activities are:
integer
Code List
17b) My leisure activities are:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
18a) If I did not have diabetic eye problems, my self-confidence would be:
integer
Code List
18a) If I did not have diabetic eye problems, my self-confidence would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
18b) My self-confidence is:
integer
Code List
18b) My self-confidence is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
19a) If I did not have diabetic eye problems, my motivation would be:
integer
Code List
19a) If I did not have diabetic eye problems, my motivation would be:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
19b) My motivation is:
integer
Code List
19b) My motivation is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
20) Are there occasions when you wish you did not need to depend on other people?
integer
Code List
20) Are there occasions when you wish you did not need to depend on other people?
CL Item
Yes (1)
CL Item
No (2)
Item
20a) If I did not have diabetic eye problems, I could do things independently:
integer
Code List
20a) If I did not have diabetic eye problems, I could do things independently:
CL Item
Very Much Better  (1)
CL Item
Much Better  (2)
CL Item
A Little Better  (3)
CL Item
The Same  (4)
CL Item
Worse (5)
Item
20b) For me, being able to do things independently is:
integer
Code List
20b) For me, being able to do things independently is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
21a) If I did not have diabetic eye problems, I would have mishaps or would lose things:
integer
Code List
21a) If I did not have diabetic eye problems, I would have mishaps or would lose things:
CL Item
Very Much Less  (1)
CL Item
Much Less  (2)
CL Item
A Little Less  (3)
CL Item
The Same  (4)
CL Item
More (5)
Item
21b) For me, not having mishaps or losing things is:
integer
Code List
21b) For me, not having mishaps or losing things is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
22a) If I did not have diabetic eye problems, the time it takes me to do things would be:
integer
Code List
22a) If I did not have diabetic eye problems, the time it takes me to do things would be:
CL Item
Very Much Less  (1)
CL Item
Much Less  (2)
CL Item
A Little Less  (3)
CL Item
The Same  (4)
CL Item
More (5)
Item
22b) The time it takes me to do things is:
integer
Code List
22b) The time it takes me to do things is:
CL Item
Very Much Easier  (1)
CL Item
Much Easier  (2)
CL Item
A Little Easier  (3)
CL Item
The Same  (4)
CL Item
More Difficult (5)
Item
23a) If I did not have diabetic eye problems, I would find taking care of my diabetes (e.g., self-testing, medication, food, exercise):
integer
Code List
23a) If I did not have diabetic eye problems, I would find taking care of my diabetes (e.g., self-testing, medication, food, exercise):
CL Item
Very Much Easier  (1)
CL Item
Much Easier  (2)
CL Item
A Little Easier  (3)
CL Item
The Same  (4)
CL Item
More Difficult (5)
Item
23b) Taking care of my diabetes is: exercise):
integer
Code List
23b) Taking care of my diabetes is: exercise):
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
24a) If I did not have diabetic eye problems, I could enjoy nature:
integer
Code List
24a) If I did not have diabetic eye problems, I could enjoy nature:
CL Item
Very Much More  (1)
CL Item
Much More  (2)
CL Item
A Little More  (3)
CL Item
The Same  (4)
CL Item
Less (5)
Item
24b) My enjoyment of nature is:
integer
Code List
24b) My enjoyment of nature is:
CL Item
Very Important  (1)
CL Item
Important  (2)
CL Item
Somewhat Important  (3)
CL Item
Not At All Important (4)
Item
25) Do your diabetic eye problems affect your quality of life in any ways that have not been covered by the questionnaire?
integer
Code List
25) Do your diabetic eye problems affect your quality of life in any ways that have not been covered by the questionnaire?
CL Item
Yes (1)
CL Item
No (2)
OTHER_SPECIFY [OTHSP]
Item
Do your diabetic eye problems affect your quality of life in any ways that have not been covered by the questionnaire? If Yes, please describe in the box provided.
text
Item Group
VITAL SIGNS (DAY 0)
VITAL_SIGNS_RECORDS [VTLREC]
Item
Were any vital signs recorded at this visit?
boolean
C1740486 (UMLS CUI [1])
VITAL_SIGNS_DT [VTLDT]
Item
Vital Signs Date:
date
C2826644 (UMLS CUI [1])
VITAL_SIGNS_TIME [VTLTM]
Item
Vital Signs Time:
time
C2827042 (UMLS CUI [1])
TEMPERATURE [TEMP]
Item
Temp:
float
C0005903 (UMLS CUI [1])
PULSE [PULSE]
Item
Pulse:
integer
C0232117 (UMLS CUI [1])
RESPIRATION [RESP]
Item
Resp:
integer
C0231832 (UMLS CUI [1])
BLOOD_PRESSURE_SYS [BPS]
Item
Blood Pressure sys:
integer
C0871470 (UMLS CUI [1])
BLOOD_PRESSURE_DIA [BPD]
Item
Blood Pressure dys:
integer
C0428883 (UMLS CUI [1])
Item Group
CONTRAST SENSITIVITY (DAY 0)
DISTANCE_CHAR [DSTCHR]
Item
Testing Distance: 1 meter
text
C0429925 (UMLS CUI [1])
EXAM_DT [EXMDT]
Item
Test Date:
date
C0200150 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
NOT_DONE [NOTDN]
Item
Right Eye: Not Done
boolean
C0430888 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
CORRECT_READING [COTRD]
Item
Total number correct =
integer
C0846621 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
CONTRAST_SENS_SCORE [TCSS]
Item
Total CS Score =
float
C0430888 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
NOT_DONE [NOTDN]
Item
Left Eye: Not Done
boolean
C0430888 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD]
Item
Total number correct =
integer
C0846621 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CONTRAST_SENS_SCORE [TCSS]
Item
Total CS Score =
float
C0430888 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Item Group
READING SPEED (DAY 0)
NOT_DONE [NOTDN]
Item
Right Eye: Not Done
boolean
C0430888 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
CARD_NUMBER [CARDNO]
Item
Card # used:
integer
C3275277 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
READING_TIME [RDTM]
Item
1a. Time to Complete:
time
C1549507 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
CORRECT_READING [COTRD]
Item
b. No. of words read CORRECTLY:
integer
C0871221 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
NOT_DONE [NOTDN]
Item
Left Eye: Not Done
boolean
C0430888 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CARD_NUMBER [CARDNO]
Item
Card # used:
integer
C3275277 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
READING_TIME [RDTM]
Item
1a. Time to Complete:
time
C1549507 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD]
Item
b. No. of words read CORRECTLY:
integer
C0871221 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Item Group
INTRAOCULAR PRESSURE (DAY 0)
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Right Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Right Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Left Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Left Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
EXAM_DT [EXMDT]
Item
Predose Date
date
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
EXAM_TIME [EXMTM]
Item
Predose Actual Time
time
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Predose Method
integer
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,3])
Code List
Predose Method
CL Item
Applanation tonometry (1)
CL Item
Non-contact tonometry (2)
CL Item
Tonopen (3)
CL Item
Pneumotonometry (4)
QV: STUDY EYE
Item
60 min post-dose Study Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
QV: STUDY EYE
Item
60 min post-dose Study Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
EXAM_DT [EXMDT]
Item
60 min post-dose Date
date
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
EXAM_TIME [EXMTM]
Item
60 min post-dose Actual Time
time
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
60 min post-dose Method
integer
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,3])
Code List
60 min post-dose Method
CL Item
Applanation tonometry (1)
CL Item
Non-contact tonometry (2)
CL Item
Tonopen (3)
CL Item
Pneumotonometry (4)
Item Group
SLITLAMP EXAMINATION (DAY 0)
EXAM_DT [EXMDT]
Item
Date of Exam:
date
C0419360 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Aqueous Cell
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0003662 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Aqueous Cell
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Aqueous Flare
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0524490 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Aqueous Flare
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
Vitreous Cell
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0042905 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Vitreous Cell
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Vitreous Hemorrhage
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0042909 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Vitreous Hemorrhage
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Cataracts Subcapsular
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0235259 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Cataracts Subcapsular
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Cataracts Cortical
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0271160 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Cataracts Cortical
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
Cataracts Nuclear
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0392557 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Cataracts Nuclear
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
LENS_RESULT [LNSRES2]
Item
Is artificial intraocular lens implant present?
boolean
C0336564 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Item
Aqueous Cell
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0003662 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Aqueous Cell
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Aqueous Flare
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0524490 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Aqueous Flare
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Vitreous Cell
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0042905 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Vitreous Cell
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Vitreous Hemorrhage
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0042909 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Vitreous Hemorrhage
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Cataracts Subcapsular
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0235259 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Cataracts Subcapsular
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Cataracts Cortical
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0271160 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Cataracts Cortical
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
Item
Cataracts Nuclear
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0392557 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Cataracts Nuclear
CL Item
N/A (1)
CL Item
0 (2)
CL Item
Trace (3)
CL Item
1+ (4)
CL Item
2+ (5)
CL Item
3+ (6)
CL Item
4+ (7)
LENS_RESULT [LNSRES2]
Item
Is artificial intraocular lens implant present?
boolean
C0336564 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Item Group
INDIRECT OPHTHALMOSCOPY (DAY 0) Right Eye
EXAM_DT [EXMDT]
Item
Date of Exam:
date
C1444582 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
MACULAR_EDEMA [MACEDM]
Item
Clinically Significant Macular Edema (CSME) Present?
boolean
C0271051 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_NEOV_DISC [OPHNVD]
Item
Neovascularization of the Disc (NVD)?
boolean
C1112634 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_NVE [OPHNVE]
Item
Neovascularization (NVE) of the Retina elsewhere?
boolean
C0035320 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_NV_IRIS [OPHIRIS]
Item
Neovascularization of the Iris?
boolean
C0271110 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
IND_OPHT_VIT_DETACH [IODET]
Item
Posterior Vitreal Detachment (PVD)?
boolean
C0423361 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_RET_HEM [OPHEM]
Item
Retinal Hemorrhages
integer
C0035317 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Item
Cotton Wool Spots
integer
C0271053 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Code List
Cotton Wool Spots
CL Item
0 (1)
CL Item
1-10 (2)
CL Item
>10 (3)
OPHTHALMO_RET_BRK_DH [OPHBD]
Item
Is there a new or worsened retinal break or detachment?
boolean
C0035321 (UMLS CUI [1,1])
C0035305 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Item Group
INDIRECT OPHTHALMOSCOPY (DAY 0) Left Eye
EXAM_DT [EXMDT]
Item
Date of Exam:
date
C1444582 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
MACULAR_EDEMA [MACEDM]
Item
Clinically Significant Macular Edema (CSME) Present?
boolean
C0271051 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_NEOV_DISC [OPHNVD]
Item
Neovascularization of the Disc (NVD)?
boolean
C1112634 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_NVE [OPHNVE]
Item
Neovascularization (NVE) of the Retina elsewhere?
boolean
C0035320 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_NV_IRIS [OPHIRIS]
Item
Neovascularization of the Iris?
boolean
C0271110 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
IND_OPHT_VIT_DETACH [IODET]
Item
Posterior Vitreal Detachment (PVD)?
boolean
C0423361 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_RET_HEM [OPHEM]
Item
Retinal Hemorrhages
integer
C0035317 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Item
Cotton Wool Spots
integer
C0271053 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Code List
Cotton Wool Spots
CL Item
0 (1)
CL Item
1-10 (2)
CL Item
>10 (3)
OPHTHALMO_RET_BRK_DH [OPHBD]
Item
Is there a new or worsened retinal break or detachment?
boolean
C0035321 (UMLS CUI [1,1])
C0035305 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])

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