ID

29411

Description

Study part: Indirect Ophthalmoscopy Screening. 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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Indirect Ophthalmoscopy Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g

English

Indirect Ophthalmoscopy Screening

1 forms  
INDIRECT OPHTHALMOSCOPY (SCREENING) RIGHT EYE
Description

INDIRECT OPHTHALMOSCOPY (SCREENING) RIGHT EYE

Alias
UMLS CUI-1
C1444582
UMLS CUI-2
C0229089
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

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Date Examined:
Description

Date Examined

Data type

date

Alias
UMLS CUI [1]
C2826643
Retina/ Retinal vessels
Description

Retina

Data type

text

Alias
UMLS CUI [1]
C0035298
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Optic disc
Description

Optic disc

Data type

text

Alias
UMLS CUI [1]
C0029127
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Macula
Description

Macula

Data type

text

Alias
UMLS CUI [1]
C0423419
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
CSME
Description

Clinically Significant Macular Edema

Data type

boolean

Alias
UMLS CUI [1]
C0730284
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Neovascularization of the Disc (NVD)?
Description

Disc neovascularization

Data type

boolean

Alias
UMLS CUI [1]
C1112634
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Neovascularization (NVE) of the retina elsewhere?
Description

Retinal neovascularization

Data type

boolean

Alias
UMLS CUI [1]
C0035320
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Neovascularization of the Iris?
Description

Iris neovascularization

Data type

boolean

Alias
UMLS CUI [1]
C0154916
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Posterior Vitreal Detachment (PVD)?
Description

Posterior Vitreal Detachment

Data type

boolean

Alias
UMLS CUI [1]
C0423361
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Retinal Hemorrhages
Description

Retinal Hemorrhages

Data type

text

Alias
UMLS CUI [1]
C0035317
Cotton Wool Spots
Description

Cotton Wool Spots

Data type

text

Alias
UMLS CUI [1]
C0271053
INDIRECT OPHTHALMOSCOPY (SCREENING) LEFT EYE
Description

INDIRECT OPHTHALMOSCOPY (SCREENING) LEFT EYE

Alias
UMLS CUI-1
C1444582
UMLS CUI-2
C0229090
Retina/ Retinal vessels
Description

Retina

Data type

text

Alias
UMLS CUI [1]
C0035298
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Optic disc
Description

Optic disc

Data type

text

Alias
UMLS CUI [1]
C0029127
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Macula
Description

Macula

Data type

text

Alias
UMLS CUI [1]
C0423419
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
CSME
Description

Clinically Significant Macular Edema

Data type

boolean

Alias
UMLS CUI [1]
C0730284
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Neovascularization of the Disc (NVD)?
Description

Disc neovascularization

Data type

boolean

Alias
UMLS CUI [1]
C1112634
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Neovascularization (NVE) of the retina elsewhere?
Description

Retinal neovascularization

Data type

boolean

Alias
UMLS CUI [1]
C0035320
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Neovascularization of the Iris?
Description

Iris neovascularization

Data type

boolean

Alias
UMLS CUI [1]
C0154916
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Posterior Vitreal Detachment (PVD)?
Description

Posterior Vitreal Detachment

Data type

boolean

Alias
UMLS CUI [1]
C0423361
Describe Abnormality
Description

Abnormality

Data type

text

Alias
UMLS CUI [1]
C1704258
Retinal Hemorrhages
Description

Retinal Hemorrhages

Data type

text

Alias
UMLS CUI [1]
C0035317
Cotton Wool Spots
Description

Cotton Wool Spots

Data type

text

Alias
UMLS CUI [1]
C0271053
RETINAL BREAK OR DETACHMENT RIGHT EYE
Description

RETINAL BREAK OR DETACHMENT RIGHT EYE

Alias
UMLS CUI-1
C0035305
UMLS CUI-2
C0229089
Is a retinal break present?
Description

retinal break

Data type

text

Alias
UMLS CUI [1]
C0035321
Is a retinal detachment present?
Description

retinal detachment

Data type

text

Alias
UMLS CUI [1]
C0035305
If retinal detachment present, specify type:
Description

retinal detachment

Data type

text

Alias
UMLS CUI [1]
C0035305
If serous, does detachment involve macula only?
Description

Serous detachment of the macula

Data type

boolean

Alias
UMLS CUI [1]
C1328517
RETINAL BREAK OR DETACHMENT LEFT EYE
Description

RETINAL BREAK OR DETACHMENT LEFT EYE

Alias
UMLS CUI-1
C0035305
UMLS CUI-2
C0229090
Is a retinal break present?
Description

retinal break

Data type

text

Alias
UMLS CUI [1]
C0035321
Is a retinal detachment present?
Description

retinal detachment

Data type

text

Alias
UMLS CUI [1]
C0035305
If retinal detachment present, specify type:
Description

retinal detachment

Data type

text

Alias
UMLS CUI [1]
C0035305
If serous, does detachment involve macula only?
Description

Serous detachment of the macula

Data type

boolean

Alias
UMLS CUI [1]
C1328517
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Similar models

Indirect Ophthalmoscopy Screening

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
INDIRECT OPHTHALMOSCOPY (SCREENING) RIGHT EYE
C1444582 (UMLS CUI-1)
C0229089 (UMLS CUI-2)
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])
Date of visit
Item
Visit Date:
date
C1320303 (UMLS CUI [1])
Date Examined
Item
Date Examined:
date
C2826643 (UMLS CUI [1])
Item
Retina/ Retinal vessels
text
C0035298 (UMLS CUI [1])
Lid
Code List
Retina/ Retinal vessels
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Item
Optic disc
text
C0029127 (UMLS CUI [1])
Lid
Code List
Optic disc
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Item
Macula
text
C0423419 (UMLS CUI [1])
Lid
Code List
Macula
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Clinically Significant Macular Edema
Item
CSME
boolean
C0730284 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Disc neovascularization
Item
Neovascularization of the Disc (NVD)?
boolean
C1112634 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Retinal neovascularization
Item
Neovascularization (NVE) of the retina elsewhere?
boolean
C0035320 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Iris neovascularization
Item
Neovascularization of the Iris?
boolean
C0154916 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Posterior Vitreal Detachment
Item
Posterior Vitreal Detachment (PVD)?
boolean
C0423361 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Item
Retinal Hemorrhages
text
C0035317 (UMLS CUI [1])
Retinal Hemorrhages
Code List
Retinal Hemorrhages
CL Item
0 (0)
CL Item
1-10 (1-10)
CL Item
>10 (>10)
Item
Cotton Wool Spots
text
C0271053 (UMLS CUI [1])
Retinal Hemorrhages
Code List
Cotton Wool Spots
CL Item
0 (0)
CL Item
1-10 (1-10)
CL Item
>10 (>10)
Item Group
INDIRECT OPHTHALMOSCOPY (SCREENING) LEFT EYE
C1444582 (UMLS CUI-1)
C0229090 (UMLS CUI-2)
Item
Retina/ Retinal vessels
text
C0035298 (UMLS CUI [1])
Lid
Code List
Retina/ Retinal vessels
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Item
Optic disc
text
C0029127 (UMLS CUI [1])
Lid
Code List
Optic disc
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Item
Macula
text
C0423419 (UMLS CUI [1])
Lid
Code List
Macula
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Clinically Significant Macular Edema
Item
CSME
boolean
C0730284 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Disc neovascularization
Item
Neovascularization of the Disc (NVD)?
boolean
C1112634 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Retinal neovascularization
Item
Neovascularization (NVE) of the retina elsewhere?
boolean
C0035320 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Iris neovascularization
Item
Neovascularization of the Iris?
boolean
C0154916 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Posterior Vitreal Detachment
Item
Posterior Vitreal Detachment (PVD)?
boolean
C0423361 (UMLS CUI [1])
Abnormality
Item
Describe Abnormality
text
C1704258 (UMLS CUI [1])
Item
Retinal Hemorrhages
text
C0035317 (UMLS CUI [1])
Retinal Hemorrhages
Code List
Retinal Hemorrhages
CL Item
0 (0)
CL Item
1-10 (1-10)
CL Item
>10 (>10)
Item
Cotton Wool Spots
text
C0271053 (UMLS CUI [1])
Retinal Hemorrhages
Code List
Cotton Wool Spots
CL Item
0 (0)
CL Item
1-10 (1-10)
CL Item
>10 (>10)
Item Group
RETINAL BREAK OR DETACHMENT RIGHT EYE
C0035305 (UMLS CUI-1)
C0229089 (UMLS CUI-2)
Item
Is a retinal break present?
text
C0035321 (UMLS CUI [1])
retinal break
Code List
Is a retinal break present?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
Is a retinal detachment present?
text
C0035305 (UMLS CUI [1])
retinal break
Code List
Is a retinal detachment present?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If retinal detachment present, specify type:
text
C0035305 (UMLS CUI [1])
retinal detachment
Code List
If retinal detachment present, specify type:
CL Item
Serous (Serous)
C0154822 (UMLS CUI-1)
(Comment:en)
CL Item
Rhegmatogenous (Rhegmatogenous)
C0271055 (UMLS CUI-1)
(Comment:en)
CL Item
Tractional (Tractional)
C0154828 (UMLS CUI-1)
(Comment:en)
Serous detachment of the macula
Item
If serous, does detachment involve macula only?
boolean
C1328517 (UMLS CUI [1])
Item Group
RETINAL BREAK OR DETACHMENT LEFT EYE
C0035305 (UMLS CUI-1)
C0229090 (UMLS CUI-2)
Item
Is a retinal break present?
text
C0035321 (UMLS CUI [1])
retinal break
Code List
Is a retinal break present?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
Is a retinal detachment present?
text
C0035305 (UMLS CUI [1])
retinal break
Code List
Is a retinal detachment present?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If retinal detachment present, specify type:
text
C0035305 (UMLS CUI [1])
retinal detachment
Code List
If retinal detachment present, specify type:
CL Item
Serous (Serous)
C0154822 (UMLS CUI-1)
(Comment:en)
CL Item
Rhegmatogenous (Rhegmatogenous)
C0271055 (UMLS CUI-1)
(Comment:en)
CL Item
Tractional (Tractional)
C0154828 (UMLS CUI-1)
(Comment:en)
Serous detachment of the macula
Item
If serous, does detachment involve macula only?
boolean
C1328517 (UMLS CUI [1])
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