ID

4426

Description

ODM derived from http://clinicaltrials.gov/show/NCT00798317

Link

http://clinicaltrials.gov/show/NCT00798317

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00798317 Symptomatic Vitreomacular Adhesion

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm OCT field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)
Description

Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm OCT field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205234
SNOMED CT 2011_0131
87017008
UMLS CUI 2011AA
C2748203
MedDRA 14.1
10070236
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0920367
SNOMED CT 2011_0131
392010000
MedDRA 14.1
10057208
UMLS CUI 2011AA
C0205216
SNOMED CT 2011_0131
1250004
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0042789
SNOMED CT 2011_0131
281004000
LOINC Version 232
MTHU014733
UMLS CUI 2011AA
C0271185
SNOMED CT 2011_0131
42134006
MedDRA 14.1
10063341
ICD-10-CM Version 2010
H53.15
UMLS CUI 2011AA
C0234632
SNOMED CT 2011_0131
13164000
MedDRA 14.1
10047531
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Any evidence of proliferative retinopathy (including PDR or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative AMD or retinal vein occlusion in the study eye
Description

Any evidence of proliferative retinopathy (including PDR or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative AMD or retinal vein occlusion in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0339467
MedDRA 14.1
10038934
UMLS CUI 2011AA
C0154830
SNOMED CT 2011_0131
59276001
MedDRA 14.1
10036857
ICD-9-CM Version 2011
362.02
UMLS CUI 2011AA
C0475224
SNOMED CT 2011_0131
255426005
UMLS CUI 2011AA
CL365148
SNOMED CT 2011_0131
399625000
MedDRA 14.1
10038923
CTCAE 1105E
E10432
UMLS CUI 2011AA
C0042905
SNOMED CT 2011_0131
47538007
UMLS CUI 2011AA
C0035320
SNOMED CT 2011_0131
61267008
MedDRA 14.1
10055666
ICD-9-CM Version 2011
362.16
UMLS CUI 2011AA
C0271084
SNOMED CT 2011_0131
414173003
MedDRA 14.1
10071129
ICD-10-CM Version 2010
H35.32
ICD-9-CM Version 2011
362.52
UMLS CUI 2011AA
C0035328
SNOMED CT 2011_0131
46085004
MedDRA 14.1
10038907
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye
Description

Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0042909
SNOMED CT 2011_0131
31341008
MedDRA 14.1
10047655
ICD-10-CM Version 2010
H43.1
ICD-9-CM Version 2011
379.23
CTCAE 1105E
E10447
UMLS CUI 2011AA
C0152006
SNOMED CT 2011_0131
422061002
MedDRA 14.1
10047658
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C2827662
UMLS CUI 2011AA
C1306519
SNOMED CT 2011_0131
280661000
UMLS CUI 2011AA
CL423353
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0450295
SNOMED CT 2011_0131
82859000
UMLS CUI 2011AA
C0920367
SNOMED CT 2011_0131
392010000
MedDRA 14.1
10057208
UMLS CUI 2011AA
C0016313
SNOMED CT 2011_0131
172581008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Subjects with macular hole diameter > 400 µm in the study eye
Description

Subjects with macular hole diameter > 400 µm in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0024441
SNOMED CT 2011_0131
232006002
MedDRA 14.1
10051058
UMLS CUI 2011AA
C1301886
SNOMED CT 2011_0131
81827009
LOINC Version 232
MTHU002654
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Aphakia in the study eye
Description

Aphakia in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0003534
SNOMED CT 2011_0131
24010005
MedDRA 14.1
10002945
ICD-10-CM Version 2010
H27.0
ICD-9-CM Version 2011
379.31
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
High myopia (> 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).
Description

High myopia (> 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).

Data type

boolean

Alias
UMLS CUI 2011AA
C0271183
SNOMED CT 2011_0131
34187009
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0007389
SNOMED CT 2011_0131
54885007
MedDRA 14.1
10007750
UMLS CUI 2011AA
C1706535
SNOMED CT 2011_0131
420708009
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm OCT field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)
Item
Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm OCT field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)
boolean
C0205234 (UMLS CUI 2011AA)
87017008 (SNOMED CT 2011_0131)
C2748203 (UMLS CUI 2011AA)
10070236 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0920367 (UMLS CUI 2011AA)
392010000 (SNOMED CT 2011_0131)
10057208 (MedDRA 14.1)
C0205216 (UMLS CUI 2011AA)
1250004 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0042789 (UMLS CUI 2011AA)
281004000 (SNOMED CT 2011_0131)
MTHU014733 (LOINC Version 232)
C0271185 (UMLS CUI 2011AA)
42134006 (SNOMED CT 2011_0131)
10063341 (MedDRA 14.1)
H53.15 (ICD-10-CM Version 2010)
C0234632 (UMLS CUI 2011AA)
13164000 (SNOMED CT 2011_0131)
10047531 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Any evidence of proliferative retinopathy (including PDR or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative AMD or retinal vein occlusion in the study eye
Item
Any evidence of proliferative retinopathy (including PDR or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative AMD or retinal vein occlusion in the study eye
boolean
C0339467 (UMLS CUI 2011AA)
10038934 (MedDRA 14.1)
C0154830 (UMLS CUI 2011AA)
59276001 (SNOMED CT 2011_0131)
10036857 (MedDRA 14.1)
362.02 (ICD-9-CM Version 2011)
C0475224 (UMLS CUI 2011AA)
255426005 (SNOMED CT 2011_0131)
CL365148 (UMLS CUI 2011AA)
399625000 (SNOMED CT 2011_0131)
10038923 (MedDRA 14.1)
E10432 (CTCAE 1105E)
C0042905 (UMLS CUI 2011AA)
47538007 (SNOMED CT 2011_0131)
C0035320 (UMLS CUI 2011AA)
61267008 (SNOMED CT 2011_0131)
10055666 (MedDRA 14.1)
362.16 (ICD-9-CM Version 2011)
C0271084 (UMLS CUI 2011AA)
414173003 (SNOMED CT 2011_0131)
10071129 (MedDRA 14.1)
H35.32 (ICD-10-CM Version 2010)
362.52 (ICD-9-CM Version 2011)
C0035328 (UMLS CUI 2011AA)
46085004 (SNOMED CT 2011_0131)
10038907 (MedDRA 14.1)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye
Item
Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye
boolean
C0042909 (UMLS CUI 2011AA)
31341008 (SNOMED CT 2011_0131)
10047655 (MedDRA 14.1)
H43.1 (ICD-10-CM Version 2010)
379.23 (ICD-9-CM Version 2011)
E10447 (CTCAE 1105E)
C0152006 (UMLS CUI 2011AA)
422061002 (SNOMED CT 2011_0131)
10047658 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C2827662 (UMLS CUI 2011AA)
C1306519 (UMLS CUI 2011AA)
280661000 (SNOMED CT 2011_0131)
CL423353 (UMLS CUI 2011AA)
C1516048 (UMLS CUI 2011AA)
C0450295 (UMLS CUI 2011AA)
82859000 (SNOMED CT 2011_0131)
C0920367 (UMLS CUI 2011AA)
392010000 (SNOMED CT 2011_0131)
10057208 (MedDRA 14.1)
C0016313 (UMLS CUI 2011AA)
172581008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Subjects with macular hole diameter > 400 µm in the study eye
Item
Subjects with macular hole diameter > 400 µm in the study eye
boolean
C0024441 (UMLS CUI 2011AA)
232006002 (SNOMED CT 2011_0131)
10051058 (MedDRA 14.1)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Aphakia in the study eye
Item
Aphakia in the study eye
boolean
C0003534 (UMLS CUI 2011AA)
24010005 (SNOMED CT 2011_0131)
10002945 (MedDRA 14.1)
H27.0 (ICD-10-CM Version 2010)
379.31 (ICD-9-CM Version 2011)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
High myopia (> 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).
Item
High myopia (> 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).
boolean
C0271183 (UMLS CUI 2011AA)
34187009 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0007389 (UMLS CUI 2011AA)
54885007 (SNOMED CT 2011_0131)
10007750 (MedDRA 14.1)
C1706535 (UMLS CUI 2011AA)
420708009 (SNOMED CT 2011_0131)
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