ID

29388

Description

Study part: 4 Meter Visual Acuity/ Right Eye Chart 1. 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

Versions (1)
  1. 3/21/18 3/21/18 -
Copyright Holder

Roche

Uploaded on

March 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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4 Meter Visual Acuity/ Right Eye Chart 1 Ranibizumab Macular Edema Diabetes Mellitus FVF4168g

English

4 Meter Visual Acuity/ Right Eye Chart 1

1 forms  
SECTION I = 4 Meter Test
Description

SECTION I = 4 Meter Test

Alias
UMLS CUI-1
C0042812
Subject Number:
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Visit Date:
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Test Date:
Description

Test Date

Data type

date

Alias
UMLS CUI [1]
C2826247
Examiner Name (print):
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Examiner (signature):
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Row
Description

Row

Data type

integer

Alias
UMLS CUI [1]
C1552840
Snellen Equivalent
Description

Snellen Equivalent

Data type

text

Alias
UMLS CUI [1]
C1827708
Chart 1 Letters
Description

Snellen chart

Data type

text

Alias
UMLS CUI [1]
C0183370
Number correct at 4 meters
Description

number correct

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C2349182
Total number correct at 4 meters
Description

Total number correct

Data type

integer

Alias
UMLS CUI [1,1]
C4288115
UMLS CUI [1,2]
C2349182
SECTION II = 1 Meter Test ADD +0.75 SPHERE
Description

SECTION II = 1 Meter Test ADD +0.75 SPHERE

Alias
UMLS CUI-1
C0042812
Row
Description

Row

Data type

integer

Alias
UMLS CUI [1]
C1552840
Snellen Equivalent
Description

Snellen Equivalent

Data type

text

Alias
UMLS CUI [1]
C1827708
Chart 1 Letters
Description

Snellen chart

Data type

text

Alias
UMLS CUI [1]
C0183370
Number correct at 1 meter
Description

number correct

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C2349182
Total number correct at 1 meter
Description

Total number correct

Data type

integer

Alias
UMLS CUI [1,1]
C4288115
UMLS CUI [1,2]
C2349182
SECTION III = Computing VA Score & Snellen Equivalent
Description

SECTION III = Computing VA Score & Snellen Equivalent

Alias
UMLS CUI-1
C2964552
A. Total number correct at 4 meters: (SECTION I)
Description

Total number correct

Data type

text

Alias
UMLS CUI [1,1]
C4288115
UMLS CUI [1,2]
C2349182
B. If A ≥ 4, write 30;otherwise, write zero
Description

score

Data type

text

Alias
UMLS CUI [1]
C0449820
C. Total correct at 1 meter (SECTION II) (If not tested, write zero)
Description

Total number correct

Data type

text

Alias
UMLS CUI [1,1]
C4288115
UMLS CUI [1,2]
C2349182
A + B + C Visual Acuity Score: Right Eye =
Description

Visual Acuity Score

Data type

integer

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0449820
SNELLEN EQUIVALENT Right Eye (Most difficult line with 1 or no errors)
Description

Snellen Equivalent

Data type

text

Alias
UMLS CUI [1]
C1827708
OR Snellen Equivalent worse than 20/800
Description

Snellen Equivalent

Data type

boolean

Alias
UMLS CUI [1]
C1827708
SECTION IV = Low Vision Testing
Description

SECTION IV = Low Vision Testing

Alias
UMLS CUI-1
C0042793
If visual acuity is not measurable, please test: Count fingers?
Description

Count fingers

Data type

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0449804
If Yes, maximum distance:
Description

distance

Data type

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0442747
Hand movement?
Description

Hand movement

Data type

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0575809
If Yes:
Description

Direction

Data type

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0449738
Light Perception?
Description

Light Perception

Data type

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C1154616
If Yes:
Description

Light Perception

Data type

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C1154616
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Similar models

4 Meter Visual Acuity/ Right Eye Chart 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SECTION I = 4 Meter Test
C0042812 (UMLS CUI-1)
Subject Number
Item
Subject Number:
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Visit Date
Item
Visit Date:
date
C1320303 (UMLS CUI [1])
Test Date
Item
Test Date:
date
C2826247 (UMLS CUI [1])
Investigator name
Item
Examiner Name (print):
text
C2826892 (UMLS CUI [1])
Investigator Signature
Item
Examiner (signature):
text
C2346576 (UMLS CUI [1])
Item
Row
integer
C1552840 (UMLS CUI [1])
Row
Code List
Row
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
Item
Snellen Equivalent
text
C1827708 (UMLS CUI [1])
Snellen Equivalent
Code List
Snellen Equivalent
CL Item
20/200 (20/200)
CL Item
20/160 (20/160)
CL Item
20/125 (20/125)
CL Item
20/100 (20/100)
CL Item
20/80 (20/80)
CL Item
20/63 (20/63)
CL Item
20/50 (20/50)
CL Item
20/40 (20/40)
CL Item
20/32 (20/32)
CL Item
20/25 (20/25)
CL Item
20/20 (20/20)
CL Item
20/16 (20/16)
CL Item
20/12.5 (20/12.5)
CL Item
20/10 (20/10)
Item
Chart 1 Letters
text
C0183370 (UMLS CUI [1])
Snellen chart
Code List
Chart 1 Letters
CL Item
N C K Z O (N C K Z O)
CL Item
R H S D K (R H S D K)
CL Item
D O V H R (D O V H R)
CL Item
C Z R H S (C Z R H S)
CL Item
O N H R C (O N H R C)
CL Item
D K S N V (D K S N V)
CL Item
Z S O K N (Z S O K N)
CL Item
C K D N R (C K D N R)
CL Item
S R Z K D (S R Z K D)
CL Item
H Z O V C (H Z O V C)
CL Item
N V D O K (N V D O K)
CL Item
V H C N O (V H C N O)
CL Item
S V H C Z (S V H C Z)
CL Item
O Z D V K (O Z D V K)
number correct
Item
Number correct at 4 meters
integer
C0237753 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Total number correct
Item
Total number correct at 4 meters
integer
C4288115 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Item Group
SECTION II = 1 Meter Test ADD +0.75 SPHERE
C0042812 (UMLS CUI-1)
Item
Row
integer
C1552840 (UMLS CUI [1])
Row
Code List
Row
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item
Snellen Equivalent
text
C1827708 (UMLS CUI [1])
Snellen Equivalent
Code List
Snellen Equivalent
CL Item
20/800 (20/800)
CL Item
20/640 (20/640)
CL Item
20/500 (20/500)
CL Item
20/400 (20/400)
CL Item
20/320 (20/320)
CL Item
20/250 (20/250)
Item
Chart 1 Letters
text
C0183370 (UMLS CUI [1])
Chart 1 Letters
Code List
Chart 1 Letters
CL Item
N C K Z O (N C K Z O)
CL Item
R H S D K (R H S D K)
CL Item
D O V H R (D O V H R)
CL Item
C Z R H S (C Z R H S)
CL Item
O N H R C (O N H R C)
CL Item
D K S N V (D K S N V)
number correct
Item
Number correct at 1 meter
integer
C0237753 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Total number correct
Item
Total number correct at 1 meter
integer
C4288115 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Item Group
SECTION III = Computing VA Score & Snellen Equivalent
C2964552 (UMLS CUI-1)
Total number correct
Item
A. Total number correct at 4 meters: (SECTION I)
text
C4288115 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
score
Item
B. If A ≥ 4, write 30;otherwise, write zero
text
C0449820 (UMLS CUI [1])
Total number correct
Item
C. Total correct at 1 meter (SECTION II) (If not tested, write zero)
text
C4288115 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Visual Acuity Score
Item
A + B + C Visual Acuity Score: Right Eye =
integer
C0042812 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Snellen Equivalent
Item
SNELLEN EQUIVALENT Right Eye (Most difficult line with 1 or no errors)
text
C1827708 (UMLS CUI [1])
Snellen Equivalent
Item
OR Snellen Equivalent worse than 20/800
boolean
C1827708 (UMLS CUI [1])
Item Group
SECTION IV = Low Vision Testing
C0042793 (UMLS CUI-1)
Item
If visual acuity is not measurable, please test: Count fingers?
text
C0042793 (UMLS CUI [1,1])
C0449804 (UMLS CUI [1,2])
undefined item
Code List
If visual acuity is not measurable, please test: Count fingers?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes, maximum distance:
text
C0042793 (UMLS CUI [1,1])
C0442747 (UMLS CUI [1,2])
undefined item
Code List
If Yes, maximum distance:
CL Item
4 ft (4 ft)
CL Item
2 ft (2 ft)
CL Item
1 ft (1 ft)
Item
Hand movement?
text
C0042793 (UMLS CUI [1,1])
C0575809 (UMLS CUI [1,2])
undefined item
Code List
Hand movement?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes:
text
C0042793 (UMLS CUI [1,1])
C0449738 (UMLS CUI [1,2])
undefined item
Code List
If Yes:
CL Item
With Direction (With Direction)
CL Item
Without Direction (Without Direction)
Item
Light Perception?
text
C0042793 (UMLS CUI [1,1])
C1154616 (UMLS CUI [1,2])
undefined item
Code List
Light Perception?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes:
text
C0042793 (UMLS CUI [1,1])
C1154616 (UMLS CUI [1,2])
undefined item
Code List
If Yes:
CL Item
With Projection (With Projection)
CL Item
Without Projection (Without Projection)
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