ID

22347

Descripción

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

Palabras clave

  1. 29/5/17 29/5/17 -
  2. 30/5/17 30/5/17 -
  3. 31/5/17 31/5/17 -
  4. 7/6/17 7/6/17 -
  5. 8/6/17 8/6/17 -
Subido en

30 de mayo de 2017

DOI

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Licencia

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)
Descripción

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)

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

PT_LANGUAGE_USED [PTLANG]

Tipo de datos

integer

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

VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0)

Date Administered:
Descripción

ADMINISTRATION_DT [ADDT]

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1]
C1302393
DD/MMM/YY
1. In general, would you say your overall health is:
Descripción

LINE_NUMBER [LN1]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN2]

Tipo de datos

integer

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

LINE_NUMBER [LN3]

Tipo de datos

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:
Descripción

LINE_NUMBER [LN4]

Tipo de datos

integer

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

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.

Tipo de datos

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:
Descripción

LINE_NUMBER [LN6]

Tipo de datos

integer

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

LINE_NUMBER [LN7]

Tipo de datos

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:
Descripción

LINE_NUMBER [LN7a]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN7b]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN7c]

Tipo de datos

integer

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

LINE_NUMBER [LN8]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN9]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN10]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN10a]

Tipo de datos

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)?
Descripción

LINE_NUMBER [LN10b]

Tipo de datos

integer

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

LINE_NUMBER [LN10c]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN11]

Tipo de datos

integer

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

LINE_NUMBER [LN12]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN13]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN14]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN15]

Tipo de datos

integer

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

LINE_NUMBER [LN15a]

Tipo de datos

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?
Descripción

LINE_NUMBER [LN15b]

Tipo de datos

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:
Descripción

LINE_NUMBER [LN15c]

Tipo de datos

integer

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

LINE_NUMBER [LN16]

Tipo de datos

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:
Descripción

LINE_NUMBER [LN16a]

Tipo de datos

integer

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

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.

Tipo de datos

integer

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

LINE_NUMBER [LN18]

Tipo de datos

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:
Descripción

LINE_NUMBER [LN19]

Tipo de datos

integer

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

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)

Tipo de datos

integer

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

LINE_NUMBER [LN21]

Tipo de datos

integer

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

LINE_NUMBER [LN22]

Tipo de datos

integer

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

LINE_NUMBER [LN23]

Tipo de datos

integer

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

LINE_NUMBER [LN24]

Tipo de datos

integer

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

LINE_NUMBER [LN25]

Tipo de datos

integer

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

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)

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

PT_LANGUAGE_USED [PTLANG]

Tipo de datos

integer

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

RetDQoL (DAY 0)

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

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.

Tipo de datos

integer

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

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.

Tipo de datos

integer

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

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.

Tipo de datos

integer

1b) Handling my household tasks is:
Descripción

FACT_QUESTION_NUMBER [FACQN4]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN5]

Tipo de datos

integer

2b) Handling my personal affairs is:
Descripción

FACT_QUESTION_NUMBER [FACQN6]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN7]

Tipo de datos

integer

3b) My experience of shopping is:
Descripción

FACT_QUESTION_NUMBER [FACQN8]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN9]

Tipo de datos

integer

4b) My feelings about the future are:
Descripción

FACT_QUESTION_NUMBER [FACQN10]

Tipo de datos

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:
Descripción

FACT_QUESTION_NUMBER [FACQN11]

Tipo de datos

integer

5b) My feelings about the past are:
Descripción

FACT_QUESTION_NUMBER [FACQN12]

Tipo de datos

integer

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

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

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN14]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN15]

Tipo de datos

integer

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

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

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN17]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN18]

Tipo de datos

integer

8) Do you have any family / relatives?
Descripción

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

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN20]

Tipo de datos

integer

8b) My family life is:
Descripción

FACT_QUESTION_NUMBER [FACQN21]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN22]

Tipo de datos

integer

9b) My friendships and social life are:
Descripción

FACT_QUESTION_NUMBER [FACQN23]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN24]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN25]

Tipo de datos

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):
Descripción

FACT_QUESTION_NUMBER [FACQN26]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN27]

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN29]

Tipo de datos

integer

12b) For me, vacations are:
Descripción

FACT_QUESTION_NUMBER [FACQN30]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN31]

Tipo de datos

integer

13b) My financial situation is:
Descripción

FACT_QUESTION_NUMBER [FACQN32]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN33]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN34]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN35]

Tipo de datos

integer

15b) My physical appearance is:
Descripción

FACT_QUESTION_NUMBER [FACQN36]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN37]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN38]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN39]

Tipo de datos

integer

17b) My leisure activities are:
Descripción

FACT_QUESTION_NUMBER [FACQN40]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN41]

Tipo de datos

integer

18b) My self-confidence is:
Descripción

FACT_QUESTION_NUMBER [FACQN42]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN43]

Tipo de datos

integer

19b) My motivation is:
Descripción

FACT_QUESTION_NUMBER [FACQN44]

Tipo de datos

integer

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

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

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN46]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN47]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN48]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN49]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN50]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN51]

Tipo de datos

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):
Descripción

FACT_QUESTION_NUMBER [FACQN52]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN53]

Tipo de datos

integer

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

FACT_QUESTION_NUMBER [FACQN54]

Tipo de datos

integer

24b) My enjoyment of nature is:
Descripción

FACT_QUESTION_NUMBER [FACQN55]

Tipo de datos

integer

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

If Yes, please describe in the box provided.

Tipo de datos

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.
Descripción

OTHER_SPECIFY [OTHSP]

Tipo de datos

text

VITAL SIGNS (DAY 0)
Descripción

VITAL SIGNS (DAY 0)

Were any vital signs recorded at this visit?
Descripción

VITAL_SIGNS_RECORDS [VTLREC]

Tipo de datos

boolean

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

VITAL_SIGNS_DT [VTLDT]

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2826644
DD/MMM/YY
Vital Signs Time:
Descripción

VITAL_SIGNS_TIME [VTLTM]

Tipo de datos

time

Alias
UMLS CUI [1]
C2827042
Temp:
Descripción

TEMPERATURE [TEMP]

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Pulse:
Descripción

PULSE [PULSE]

Tipo de datos

integer

Unidades de medida
  • /min
Alias
UMLS CUI [1]
C0232117
/min
Resp:
Descripción

RESPIRATION [RESP]

Tipo de datos

integer

Unidades de medida
  • /min
Alias
UMLS CUI [1]
C0231832
/min
Blood Pressure sys:
Descripción

BLOOD_PRESSURE_SYS [BPS]

Tipo de datos

integer

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

BLOOD_PRESSURE_DIA [BPD]

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
CONTRAST SENSITIVITY (DAY 0)
Descripción

CONTRAST SENSITIVITY (DAY 0)

Testing Distance: 1 meter
Descripción

DISTANCE_CHAR [DSTCHR]

Tipo de datos

text

Alias
UMLS CUI [1]
C0429925
Test Date:
Descripción

EXAM_DT [EXMDT]

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0200150
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Right Eye: Not Done
Descripción

NOT_DONE [NOTDN]

Tipo de datos

boolean

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

CORRECT_READING [COTRD]

Tipo de datos

integer

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

[(Total number correct - 3) X 0.05]

Tipo de datos

float

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

NOT_DONE [NOTDN]

Tipo de datos

boolean

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

CORRECT_READING [COTRD]

Tipo de datos

integer

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

[(Total number correct - 3) X 0.05]

Tipo de datos

float

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

READING SPEED (DAY 0)

Right Eye: Not Done
Descripción

NOT_DONE [NOTDN]

Tipo de datos

boolean

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

CARD_NUMBER [CARDNO]

Tipo de datos

integer

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

READING_TIME [RDTM]

Tipo de datos

time

Unidades de medida
  • m:ss
Alias
UMLS CUI [1,1]
C1549507
UMLS CUI [1,2]
C0229089
m:ss
b. No. of words read CORRECTLY:
Descripción

CORRECT_READING [COTRD]

Tipo de datos

integer

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

NOT_DONE [NOTDN]

Tipo de datos

boolean

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

CARD_NUMBER [CARDNO]

Tipo de datos

integer

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

READING_TIME [RDTM]

Tipo de datos

time

Unidades de medida
  • m:ss
Alias
UMLS CUI [1,1]
C1549507
UMLS CUI [1,2]
C0229090
m:ss
b. No. of words read CORRECTLY:
Descripción

CORRECT_READING [COTRD]

Tipo de datos

integer

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

INTRAOCULAR PRESSURE (DAY 0)

Pre-dose Right Eye
Descripción

INTRAOCULAR_PRESSURE [ IOP]

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229089
mmHg
Pre-dose Right Eye Not Done
Descripción

INTRAOCULAR_PRESSURE [ IOP]

Tipo de datos

boolean

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

INTRAOCULAR_PRESSURE [ IOP]

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229090
mmHg
Pre-dose Left Eye Not Done
Descripción

INTRAOCULAR_PRESSURE [ IOP]

Tipo de datos

boolean

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

EXAM_DT [EXMDT]

Tipo de datos

date

Unidades de medida
  • 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
Descripción

EXAM_TIME [EXMTM]

Tipo de datos

time

Unidades de medida
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0040223
24 hr clock
Predose Method
Descripción

Method must be consistent for a subject throughout the study.

Tipo de datos

integer

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

QV: STUDY EYE

Tipo de datos

integer

Unidades de medida
  • 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
Descripción

QV: STUDY EYE

Tipo de datos

boolean

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

EXAM_DT [EXMDT]

Tipo de datos

date

Unidades de medida
  • 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
Descripción

EXAM_TIME [EXMTM]

Tipo de datos

time

Unidades de medida
  • 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
Descripción

Method must be consistent for a subject throughout the study.

Tipo de datos

integer

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

SLITLAMP EXAMINATION (DAY 0)

Date of Exam:
Descripción

EXAM_DT [EXMDT]

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Aqueous Cell
Descripción

SLIT_LAMP_AQ_CELL [SLAQC]

Tipo de datos

integer

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

SLIT_LAMP_AQ_FLARE [SLAQF]

Tipo de datos

integer

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

SLIT_LAMP_VIT_CELL [SLVITC]

Tipo de datos

integer

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

SLIT_LAMP_VIT_HEM [SLHEM]

Tipo de datos

integer

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

SLIT_LAMP_CATA_SUB [SLCAS]

Tipo de datos

integer

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

SLIT_LAMP_CATA_CORT [SLCAC]

Tipo de datos

integer

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

SLIT_LAMP_CATA_NUC [SLCAN]

Tipo de datos

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?
Descripción

LENS_RESULT [LNSRES2]

Tipo de datos

boolean

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

SLIT_LAMP_AQ_CELL [SLAQC]

Tipo de datos

integer

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

SLIT_LAMP_AQ_FLARE [SLAQF]

Tipo de datos

integer

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

SLIT_LAMP_VIT_CELL [SLVITC]

Tipo de datos

integer

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

SLIT_LAMP_VIT_HEM [SLHEM]

Tipo de datos

integer

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

SLIT_LAMP_CATA_SUB [SLCAS]

Tipo de datos

integer

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

SLIT_LAMP_CATA_CORT [SLCAC]

Tipo de datos

integer

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

SLIT_LAMP_CATA_NUC [SLCAN]

Tipo de datos

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?
Descripción

LENS_RESULT [LNSRES2]

Tipo de datos

boolean

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

INDIRECT OPHTHALMOSCOPY (DAY 0)

Date of Exam:
Descripción

EXAM_DT [EXMDT]

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Clinically Significant Macular Edema (CSME) Present?
Descripción

MACULAR_EDEMA [MACEDM]

Tipo de datos

boolean

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

OPHTHALMO_NEOV_DISC [OPHNVD]

Tipo de datos

boolean

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

OPHTHALMO_NVE [OPHNVE]

Tipo de datos

boolean

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

OPHTHALMO_NV_IRIS [OPHIRIS]

Tipo de datos

boolean

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

IND_OPHT_VIT_DETACH [IODET]

Tipo de datos

boolean

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

OPHTHALMO_RET_HEM [OPHEM]

Tipo de datos

integer

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

OPHTHALMO_COTTON [OPHCOT]

Tipo de datos

integer

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

OPHTHALMO_RET_BRK_DH [OPHBD]

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035321
UMLS CUI [1,2]
C0035305
UMLS CUI [1,3]
C0229089

Similar models

DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
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])

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