ID

27251

Descrição

MACULAR DEGENERATION DATA COLLECTION Version 3.0.1 Revised: April 10th, 2017, International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Conditions: Neovascular Macular Degeneration Neovascular Age Related Macular Degeneration | Polypoidal Choroidal Vasculopathy | Myopic Neovascular Macular Degeneration | Other Forms of Neovascular Macular Degeneration (includes Post-Traumatic, Inflammatory, Idiopathic, Macular Telangiectasia Type 2) Non-Neovascular Age Related Macular Degeneration Treatment Approaches: Intravitreal anti-VEGF treatment | Other intravitreal treatment | Photodynamic therapy | Thermal laser photocoagulation | Retinal radiation therapy | Transpupillary thermotherapy | Retinal surgical treatment

Link

http://www.ichom.org/

Palavras-chave

Versões (9)
  1. 16/10/2017 16/10/2017 -
  2. 18/10/2017 18/10/2017 -
  3. 20/10/2017 20/10/2017 -
  4. 05/11/2017 05/11/2017 -
  5. 05/11/2017 05/11/2017 -
  6. 05/11/2017 05/11/2017 -
  7. 04/12/2017 04/12/2017 -
  8. 03/02/2018 03/02/2018 -
  9. 17/09/2021 17/09/2021 -
Titular dos direitos

ICHOM

Transferido a

5 de novembro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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ICHOM Macular Degeneration

Inglês

ICHOM Macular Degeneration

1 Formulários  
Demographic factors
Descrição

Demographic factors

What is your date of birth?
Descrição

Age in years, calculated from birth date at commencement of therapy INCLUSION CRITERIA: ALl patients TIMING: Baseline REPORTING SOURCE: Clinical or administrative data

Tipo de dados

date

Unidades de medida
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C0421451
DD/MM/YYYY
Please indicate your sex at birth
Descrição

INCLUSION CRITERIA: ALl patients TIMING: Baseline REPORTING SOURCE: Clinical or administrative data

Tipo de dados

integer

Alias
UMLS CUI [1]
C0079399
What is your ethnicity?
Descrição

Note that regulations on reporting ethnicity may differ per country INCLUSION CRITERIA: ALl patients TIMING: Baseline REPORTING SOURCE: Patient-reported

Tipo de dados

integer

Alias
UMLS CUI [1]
C0015031
Do you smoke?
Descrição

Smoking status (of cigarettes, cigars or tobacco) INCLUSION CRITERIA: ALl patients TIMING: Baseline REPORTING SOURCE: Patient-reported

Tipo de dados

integer

Alias
UMLS CUI [1]
C1519386
Baseline Functional Status
Descrição

Baseline Functional Status

Indicate the patient's distance visual acuity
Descrição

Distance visual acuity (best of uncorrected, corrected using glasses or contact lenses, or pinhole) in the affected eye INCLUSION CRITERIA: ALl patients TIMING: Baseline REPORTING SOURCE: Clinical RESPONSE OPTIONS: Numerical value preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. Please refer to page 13 for a Snellen to LogMAR conversion table.

Tipo de dados

integer

Alias
UMLS CUI [1]
C0042812
Indicate the patient's distance visual acuity in the other (non study) eye
Descrição

Distance visual acuity (best of uncorrected, corrected using glasses or contact lenses, or pinhole) in the fellow eye INCLUSION CRITERIA: ALl patients TIMING: Baseline REPORTING SOURCE: Clinical RESPONSE OPTIONS: Numerical value preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. Please refer to page 13 for a Snellen to LogMAR conversion table.

Tipo de dados

integer

Chart type used for distance visual acuity measurement
Descrição

Results preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. INCLUSION CRITERIA: ALl patients TIMING: Baseline REPORTING SOURCE: Clinical

Tipo de dados

integer

Distance at which distance visual acuity is measured
Descrição

INCLUSION CRITERIA: ALl patients TIMING: Baseline REPORTING SOURCE: Clinical RESPONSE OPTIONS: Record details of the distance at which visual acuity is measured

Tipo de dados

integer

Baseline clinical status
Descrição

Baseline clinical status

Indicate the type of macular degeneration
Descrição

INCLUSION CRITERIA: ALl patients TIMING: Baseline Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Alias
UMLS CUI [1]
C0024437
Indicate the presence of geographic atrophy anywhere in the macular area that is not contiguous with the main lesion
Descrição

Geographic atrophy is defined as an area of hypopigmentation or hyperfluorescence of at least 250 μm in its minimum linear dimension with 2 of the 3 following characteristics: (i) circular shape, (ii) sharp borders, or (iii) visibility of choroidal vessels within the area of geographic atrophy INCLUSION CRITERIA: ALl patients TIMING: Baseline Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Indicate the presence of subretinal fibrosis
Descrição

Abnormal thickening of the subretinal tissue complex (material between Bruch's membrane and outer retina) anywhere in the macular area INCLUSION CRITERIA: ALl patients TIMING: Baseline Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Indicate the presence of pigment epithelial detachment
Descrição

Discrete elevations of the retinal pigment epithelium (RPE) anywhere in the macular area with solid (fibrovascular or haemorrhagic PED) or fluid (serous PED) matter below the corresponding retinal pigment epithelium INCLUSION CRITERIA: ALl patients TIMING: Baseline Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Alias
UMLS CUI [1]
C0035305
Indicate the type of pigment epithelial detachment
Descrição

Solid (fibrovascular or haemorrhagic) or fluid (Serous) PED below the corresponding retinal pigment epithelium INCLUSION CRITERIA: All patients If answered '1' or '2' on Pigment epithelial detachment (PED) TIMING: Baseline Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Associated clinical history
Descrição

Associated clinical history

Indicate ocular comorbidities
Descrição

Select all that apply INCLUSION CRITERIA: All patients TIMING: Baseline Annually from baseline REPORTING SOURCE: Clinical TYPE: Multiple answers Separate multiple entries with "";""

Tipo de dados

integer

Alias
UMLS CUI [1]
C0009488
Indicate previous macular degeneration treatment in affected eye (multiple options possible)
Descrição

Select all that apply INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Multiple answers Separate multiple entries with "";""

Tipo de dados

integer

Alias
UMLS CUI [1]
C0009488
Other ocular treatments
Descrição

Other ocular treatments

Indicate if the patient received cataract surgery in the affected/study eye
Descrição

INCLUSION CRITERIA: ALl patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Alias
UMLS CUI [1]
C2939459
Indicate the date of the cataract surgery
Descrição

INCLUSION CRITERIA: All patients If answered 'yes' on cataract surgery (CATSURGTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical

Tipo de dados

date

Unidades de medida
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C2939459
UMLS CUI [1,2]
C011008
DD/MM/YYYY
Indicate if the patient received YAG laser capsulotomy in the affected/study eye
Descrição

INCLUSION CRITERIA: All patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C0197674
Indicate the date of the YAG laser capsulotomy
Descrição

INCLUSION CRITERIA: All patients If answered 'yes' on YAG laser capsulotomy (YAGLASERTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical

Tipo de dados

date

Unidades de medida
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C0197674
UMLS CUI [1,3]
C011008
DD/MM/YYYY
Indicate if the patient received retinal laser therapy in the affected/study eye
Descrição

i.e. for macular edema or diabetic retinopathy INCLUSION CRITERIA: All patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0850168
UMLS CUI [1,2]
C0450295
Indicate the date of the retinal laser therapy
Descrição

INCLUSION CRITERIA: All patients If answered 'yes' on retinal laser (RETLASERTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical

Tipo de dados

date

Unidades de medida
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0850168
UMLS CUI [1,2]
C0450295
UMLS CUI [1,3]
C011008
DD/MM/YYYY
Indicate if the patient received vitrectomy in the affected/study eye
Descrição

INCLUSION CRITERIA: All patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo de dados

integer

Alias
UMLS CUI [1]
C0042903
Indicate the date of the vitrectomy
Descrição

INCLUSION CRITERIA: All patients If answered 'yes' on vitrectomy (VITRTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical

Tipo de dados

date

Unidades de medida
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0042903
UMLS CUI [1,2]
C011008
DD/MM/YYYY
Indicate if the patient received corneal surgery in the affected/study eye
Descrição

i.e. graft, pterygium INCLUSION CRITERIA: All patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo de dados

integer

Alias
UMLS CUI [1]
C0197402
Indicate the date of the corneal surgery
Descrição

INCLUSION CRITERIA: All patients If answered 'yes' on corneal surgery (CORNSURGTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical

Tipo de dados

date

Unidades de medida
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0197402
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Treatment variables
Descrição

Treatment variables

Indicate the name of the received treatment for macular degeneration
Descrição

INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""

Tipo de dados

integer

Alias
UMLS CUI [1]
C0087111
Burden of treatment
Descrição

Burden of treatment

Complications of treatment
Descrição

Complications of treatment

Indicate if patient was diagnosed with endophthalmitis in the treated eye
Descrição

Severe intra-ocular inflammation within 3 months of last intra-ocular treatment, due to infectious or non-infectious causes INCLUSION CRITERIA: Neovascular macular disease patients receiving treatment TIMING: Each clinical visit REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Alias
UMLS CUI [1]
C0014236
Disease activity
Descrição

Disease activity

Indicate the presence of fluid, edema, or hemorrhage
Descrição

Presence of intraretinal or subretinal fluid or hemorrhage that is attributable to activity of the neovascular lesion as determined by the treating ophthalmologist. This could be based on clinical examination or imaging INCLUSION CRITERIA: Neovascular macular disease patients receiving treatment TIMING: Each clinical visit REPORTING SOURCE: Clinical TYPE: Single answer

Tipo de dados

integer

Alias
UMLS CUI [1]
C0013604
UMLS CUI [2]
C0019080
Visual functioning and health related quality of life
Descrição

Visual functioning and health related quality of life

Indicate the patient's distance visual acuity
Descrição

Distance visual acuity (best of uncorrected, corrected using glasses or contact lenses, or pinhole) in the affected eye INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical RESPONSE OPTIONS: Numerical value preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. Please refer to page 13 for a Snellen to LogMAR conversion table. Change in distance visual acuity should be calculated from baseline and previous visual acuity assessments.

Tipo de dados

integer

Chart type used for distance visual acuity measurement
Descrição

Results preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical RESPONSE OPTIONS: Numerical value preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. Please refer to page 13 for a Snellen to LogMAR conversion table. Change in distance visual acuity should be calculated from baseline and previous visual acuity assessments.

Tipo de dados

integer

Distance at which distance visual acuity is measured
Descrição

INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical RESPONSE OPTIONS: Record details of the distance at which visual acuity is measured

Tipo de dados

integer

In the past month, how much has your eyesight interfered with recognizing or meeting people?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how much has your eyesight interfered with reading labels or instructions on medicines?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how much has your eyesight interfered with operating household appliances and the telephone?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how often has your eyesight made you go carefully to avoid falling or tripping?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how much has your eyesight interfered with reading ordinary size print? (for example newspapers)
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how often has your eyesight made you concerned or worried about your general safety at home?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how often has your eyesight made you concerned or worried about spilling or breaking things?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how often has your eyesight made you concerned or worried about your general safety when out of your home?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how often have you needed help from other people because of your eyesight?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, have you felt frustrated or annoyed because of your eyesight?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, have you felt lonely or isolated because of your eyesight?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how often have you worried about your eyesight getting worse?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how often has your eyesight made you concerned or worried about coping with everyday life?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, have you felt like a nuisance or a burden because of your eyesight?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

In the past month, how much has your eyesight interfered with your life in general?
Descrição

INCLUSION CRITERIA: All patients TIMING: Baseline 1 year post initiation of treatment and tracked ongoing annually while under follow-up REPORTING SOURCE: Patient-reported TYPE: Single answer

Tipo de dados

integer

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ICHOM Macular Degeneration

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Demographic factors
age
Item
What is your date of birth?
date
C0421451 (UMLS CUI [1])
Item
Please indicate your sex at birth
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Please indicate your sex at birth
CL Item
Male (0)
CL Item
Female (1)
CL Item
Undisclosed (999)
Item
What is your ethnicity?
integer
C0015031 (UMLS CUI [1])
Sex
Code List
What is your ethnicity?
CL Item
Asian  (1)
CL Item
Black (2)
CL Item
Hispanic  (3)
CL Item
White (4)
CL Item
Mixed/multiple ethnic origins  (5)
CL Item
Other (888)
Item
Do you smoke?
integer
C1519386 (UMLS CUI [1])
Sex
Code List
Do you smoke?
CL Item
Current smoker (1)
CL Item
Former smoker (2)
CL Item
Never smoked (3)
CL Item
Unknown/Undisclosed (999)
Item Group
Baseline Functional Status
Distance visual acuity
Item
Indicate the patient's distance visual acuity
integer
C0042812 (UMLS CUI [1])
Distance visual acuity in the fellow eye
Item
Indicate the patient's distance visual acuity in the other (non study) eye
integer
Item
Chart type used for distance visual acuity measurement
integer
Chart type
Code List
Chart type used for distance visual acuity measurement
CL Item
LogMAR (1)
CL Item
Snellen (2)
Distance at which distance visual acuity is measured
Item
Distance at which distance visual acuity is measured
integer
Item Group
Baseline clinical status
Item
Indicate the type of macular degeneration
integer
C0024437 (UMLS CUI [1])
Type of macular degeneration
Code List
Indicate the type of macular degeneration
CL Item
Neovascular age related macular degeneration (1)
CL Item
Myopic neovascular macular degeneration (2)
CL Item
Other neovascular macular degeneration (3)
CL Item
Polypoidal choroidal vasculopathy (4)
CL Item
Dry/non-neovascular age related macular degeneration (5)
Item
Indicate the presence of geographic atrophy anywhere in the macular area that is not contiguous with the main lesion
integer
Type of macular degeneration
Code List
Indicate the presence of geographic atrophy anywhere in the macular area that is not contiguous with the main lesion
CL Item
Subfoveal (present and involving the subfoveal area) (1)
CL Item
Extra-foveal (present, but not involving the subfoveal area) (2)
CL Item
Not present (0)
Item
Indicate the presence of subretinal fibrosis
integer
Subretinal fibrosis
Code List
Indicate the presence of subretinal fibrosis
CL Item
Not present (0)
CL Item
Subfoveal (present and involving the subfoveal area) (1)
CL Item
Extra-foveal (present, but not involving the subfoveal area) (2)
Item
Indicate the presence of pigment epithelial detachment
integer
C0035305 (UMLS CUI [1])
Subretinal fibrosis
Code List
Indicate the presence of pigment epithelial detachment
CL Item
Not present (0)
CL Item
Subfoveal (present and involving the subfoveal area) (1)
CL Item
Extra-foveal (present, but not involving the subfoveal area) (2)
Item
Indicate the type of pigment epithelial detachment
integer
Subretinal fibrosis
Code List
Indicate the type of pigment epithelial detachment
CL Item
Solid (Fibrovascular or haemorrhagic) PED below the corresponding retinal pigment epithelium (1)
CL Item
Fluid (Serous) PED below the corresponding retinal pigment epithelium (2)
Item Group
Associated clinical history
Item
Indicate ocular comorbidities
integer
C0009488 (UMLS CUI [1])
Ocular comorbidities
Code List
Indicate ocular comorbidities
CL Item
Retinal vascular disease (presence of any retinal vascular disease such as diabetic retinopathy, retinal vein occlusion, retinal artery occlusion) (1)
CL Item
Other macular pathology (presence of any other macular pathology such as , diabetic macular edema, epiretinal membrane, macular hole, macular dystrophy etc.) (2)
CL Item
Glaucoma or other optic neuropathy (confirmed diagnosis of glaucoma or other optic neuropathy has been made) (3)
CL Item
Amblyopia (presence of amblyopia) (4)
CL Item
Media opacity (presence of media opacity from cataract or corneal pathology etc.) (5)
CL Item
Other (888)
Item
Indicate previous macular degeneration treatment in affected eye (multiple options possible)
integer
C0009488 (UMLS CUI [1])
Ocular comorbidities
Code List
Indicate previous macular degeneration treatment in affected eye (multiple options possible)
CL Item
Previous intravitreal anti-VEGF treatment (1)
CL Item
Intravitreal steroid (2)
CL Item
Photodynamic therapy (3)
CL Item
Thermal laser photocoagulation (4)
CL Item
Retinal radiation therapy (5)
CL Item
Other (888)
CL Item
None (0)
CL Item
Transpupillary thermotherapy (6)
CL Item
Retinal surgical treatment (7)
CL Item
Unknown/Undisclosed (999)
Item Group
Other ocular treatments
Item
Indicate if the patient received cataract surgery in the affected/study eye
integer
C2939459 (UMLS CUI [1])
Cataract surgery
Code List
Indicate if the patient received cataract surgery in the affected/study eye
CL Item
No (0)
CL Item
Yes (1)
Date of cataract surgery
Item
Indicate the date of the cataract surgery
date
C2939459 (UMLS CUI [1,1])
C011008 (UMLS CUI [1,2])
Item
Indicate if the patient received YAG laser capsulotomy in the affected/study eye
integer
C0023089 (UMLS CUI [1,1])
C0197674 (UMLS CUI [1,2])
YAG laser capsulotomy
Code List
Indicate if the patient received YAG laser capsulotomy in the affected/study eye
CL Item
No (0)
CL Item
Yes (1)
Date of YAG laser capsulotomy
Item
Indicate the date of the YAG laser capsulotomy
date
C0023089 (UMLS CUI [1,1])
C0197674 (UMLS CUI [1,2])
C011008 (UMLS CUI [1,3])
Item
Indicate if the patient received retinal laser therapy in the affected/study eye
integer
C0850168 (UMLS CUI [1,1])
C0450295 (UMLS CUI [1,2])
Retinal laser
Code List
Indicate if the patient received retinal laser therapy in the affected/study eye
CL Item
No (0)
CL Item
Yes (1)
Date of retinal laser
Item
Indicate the date of the retinal laser therapy
date
C0850168 (UMLS CUI [1,1])
C0450295 (UMLS CUI [1,2])
C011008 (UMLS CUI [1,3])
Item
Indicate if the patient received vitrectomy in the affected/study eye
integer
C0042903 (UMLS CUI [1])
Vitrectomy
Code List
Indicate if the patient received vitrectomy in the affected/study eye
CL Item
No (0)
CL Item
Yes (1)
Date of vitrectomy
Item
Indicate the date of the vitrectomy
date
C0042903 (UMLS CUI [1,1])
C011008 (UMLS CUI [1,2])
Item
Indicate if the patient received corneal surgery in the affected/study eye
integer
C0197402 (UMLS CUI [1])
Corneal surgery
Code List
Indicate if the patient received corneal surgery in the affected/study eye
CL Item
No (0)
CL Item
Yes (1)
Date of corneal surgery
Item
Indicate the date of the corneal surgery
date
C0197402 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Treatment variables
Item
Indicate the name of the received treatment for macular degeneration
integer
C0087111 (UMLS CUI [1])
Name of treatments received
Code List
Indicate the name of the received treatment for macular degeneration
CL Item
None (0)
CL Item
Ranibizumab (Lucentis)  (1)
CL Item
Bevacizumab (Avastin)  (2)
CL Item
Pegaptanib (Macugen)  (3)
CL Item
Aflibercept (VEGF-trap/Eylea)  (4)
CL Item
Intravitreal steroid (5)
CL Item
Photodynamic therapy (6)
CL Item
Thermal laser photocoagulation (7)
CL Item
Retinal radiation therapy (8)
CL Item
Transpupillary thermotherapy (9)
CL Item
Retinal surgical treatment (10)
CL Item
Other (888)
CL Item
Unknown/Undisclosed (999)
Item Group
Burden of treatment
Item Group
Complications of treatment
Item
Indicate if patient was diagnosed with endophthalmitis in the treated eye
integer
C0014236 (UMLS CUI [1])
Endophthalmitis
Code List
Indicate if patient was diagnosed with endophthalmitis in the treated eye
CL Item
No (0)
CL Item
Infectious endophthalmitis – suspected or proven intra-ocular infection. This includes all cases of suspected infectious endophthalmitis, whether culture-proven (i.e. positive culture) or those with a negative culture that behave clinically like infection (i.e. responsive to antibiotic treatment) (1)
CL Item
Non-infectious endophthalmitis – not suspected to be caused by intra-ocular infection. This excludes all cases of suspected infectious endophthalmitis, whether culture-proven (i.e. positive culture) or those with a negative culture that behave clinically like infection (i.e. responsive to antibiotic treatment) (2)
Item Group
Disease activity
Item
Indicate the presence of fluid, edema, or hemorrhage
integer
C0013604 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
Presence of fluid, edema, or hemorrhage
Code List
Indicate the presence of fluid, edema, or hemorrhage
CL Item
Active - presence of intraretinal or subretinal fluid or hemorrhage attributable to activity of the neovascular lesion (1)
CL Item
Inactive - no signs of clinically significant activity (2)
Item Group
Visual functioning and health related quality of life
Distance visual acuity – absolute & change
Item
Indicate the patient's distance visual acuity
integer
Item
Chart type used for distance visual acuity measurement
integer
Chart type
Code List
Chart type used for distance visual acuity measurement
CL Item
LogMAR (1)
CL Item
Snellen (2)
Distance at which distance visual acuity is measured
Item
Distance at which distance visual acuity is measured
integer
Item
In the past month, how much has your eyesight interfered with recognizing or meeting people?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how much has your eyesight interfered with recognizing or meeting people?
CL Item
Not at all (0)
CL Item
A little (1)
CL Item
A fair amount (2)
CL Item
A lot (3)
CL Item
Don't do this for other reasons (8)
Item
In the past month, how much has your eyesight interfered with reading labels or instructions on medicines?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how much has your eyesight interfered with reading labels or instructions on medicines?
CL Item
Not at all (0)
CL Item
A little (1)
CL Item
A fair amount (2)
CL Item
A lot (3)
CL Item
Don't do this for other reasons (8)
Item
In the past month, how much has your eyesight interfered with operating household appliances and the telephone?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how much has your eyesight interfered with operating household appliances and the telephone?
CL Item
Not at all (0)
CL Item
A little (1)
CL Item
A fair amount (2)
CL Item
A lot (3)
CL Item
Don't do this for other reasons (8)
Item
In the past month, how often has your eyesight made you go carefully to avoid falling or tripping?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how often has your eyesight made you go carefully to avoid falling or tripping?
CL Item
Not at all (0)
CL Item
A little (1)
CL Item
A fair amount (2)
CL Item
A lot (3)
CL Item
Don't do this for other reasons (8)
Item
In the past month, how much has your eyesight interfered with reading ordinary size print? (for example newspapers)
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how much has your eyesight interfered with reading ordinary size print? (for example newspapers)
CL Item
Not at all (0)
CL Item
A fair amount (1)
CL Item
A lot (2)
CL Item
Don't do this for other reasons (8)
Item
In the past month, how often has your eyesight made you concerned or worried about your general safety at home?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how often has your eyesight made you concerned or worried about your general safety at home?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, how often has your eyesight made you concerned or worried about spilling or breaking things?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how often has your eyesight made you concerned or worried about spilling or breaking things?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, how often has your eyesight made you concerned or worried about your general safety when out of your home?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how often has your eyesight made you concerned or worried about your general safety when out of your home?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, how often have you needed help from other people because of your eyesight?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how often have you needed help from other people because of your eyesight?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, have you felt frustrated or annoyed because of your eyesight?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, have you felt frustrated or annoyed because of your eyesight?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, have you felt lonely or isolated because of your eyesight?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, have you felt lonely or isolated because of your eyesight?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, how often have you worried about your eyesight getting worse?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how often have you worried about your eyesight getting worse?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, how often has your eyesight made you concerned or worried about coping with everyday life?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how often has your eyesight made you concerned or worried about coping with everyday life?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, have you felt like a nuisance or a burden because of your eyesight?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, have you felt like a nuisance or a burden because of your eyesight?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
Item
In the past month, how much has your eyesight interfered with your life in general?
integer
Question 1 of Brief IVI - Reading and accessing information
Code List
In the past month, how much has your eyesight interfered with your life in general?
CL Item
Not at all (0)
CL Item
A little of the time (1)
CL Item
A fair amount of the time (2)
CL Item
A lot of the time (3)
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