ID

42353

Description

Electric Stimulation of the Eye to Improve Vision After Trauma; ODM derived from: https://clinicaltrials.gov/show/NCT02019927

Link

https://clinicaltrials.gov/show/NCT02019927

Keywords

Versions (1)
  1. 6/22/21 6/22/21 -
Copyright Holder

Wills Eye United States Department of Defense

Uploaded on

June 22, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-arteritic Anterior Ischemic Optic Neuropathy NCT02019927

English

Eligibility Non-arteritic Anterior Ischemic Optic Neuropathy NCT02019927

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
you are 18 years or older.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
you have sustained trauma (more than 3 months before this study) or been diagnosed with non-arteritic anterior ischemic optic neuropathy (naion) (more than 6 months before this study) or been diagnosed with multiple sclerosis (ms) and suffered visual loss (more than 3 months before this study).
Description

Trauma | Diagnosis of non-arteritic anterior ischemic optic neuropathy (naion) | Diagnosis of multiple sclerosis with a visual loss

Data type

boolean

Alias
UMLS CUI [1]
C3714660
UMLS CUI [2]
C1852242
UMLS CUI [3,1]
C0026769
UMLS CUI [3,2]
C1410229
you are willing and able to give written informed consent.
Description

Willing and able to give an informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0085732
you are able to commit to enrolling in the study during the full time period of up to 6 months.
Description

Commintment to the study for up to 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0870312
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0008976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
you have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/- six diopters of myopia, retinal detachment, exudative age-related macular degeneration).
Description

Other significant opthalmologic disease or condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0750502
you have amblyopia (lazy eye) in affected eye, previously diagnosed.
Description

Previously diagnosed amblyopia in the affected eye

Data type

boolean

Alias
UMLS CUI [1,1]
C0002418
UMLS CUI [1,2]
C0449642
UMLS CUI [1,3]
C0332132
you are participating in any other interventional clinical trial.
Description

Participation in other intenventional clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3274035
if you are pregnant or a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration or woman unwilling to perform a pregnancy test at study entry/screening.
Description

Pregnancy | Absence of medically acceptable means of birth control in women of childbearing potential | Unwilling to perform a pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0032976
UMLS CUI [3,2]
C0558080
you are unable to give signed consent due to memory, medical, communication, language, or mental health problems.
Description

Unable to give informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
you are less than 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
you are unable or unwilling to complete the evaluation or questionnaire.
Description

Unable or unwilling to complete questionnaires or evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0220825
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0220825
UMLS CUI [4,2]
C0558080
visual acuity better than 20/40
Description

Visual acuity

Data type

boolean

Alias
UMLS CUI [1]
C0042812
inability to detect phosphenes during threshold detection
Description

Inability to detect phosphenes during threshold detection

Data type

boolean

Alias
UMLS CUI [1,1]
C1709528
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0449864
UMLS CUI [1,4]
C1511790
you are on seizure medications, or have a history of epilepsy.
Description

Medical history of epilepsy | Seizure medications

Data type

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0036572
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Similar models

Eligibility Non-arteritic Anterior Ischemic Optic Neuropathy NCT02019927

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
you are 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Trauma | Diagnosis of non-arteritic anterior ischemic optic neuropathy (naion) | Diagnosis of multiple sclerosis with a visual loss
Item
you have sustained trauma (more than 3 months before this study) or been diagnosed with non-arteritic anterior ischemic optic neuropathy (naion) (more than 6 months before this study) or been diagnosed with multiple sclerosis (ms) and suffered visual loss (more than 3 months before this study).
boolean
C3714660 (UMLS CUI [1])
C1852242 (UMLS CUI [2])
C0026769 (UMLS CUI [3,1])
C1410229 (UMLS CUI [3,2])
Willing and able to give an informed consent
Item
you are willing and able to give written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Commintment to the study for up to 6 months
Item
you are able to commit to enrolling in the study during the full time period of up to 6 months.
boolean
C0870312 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Other significant opthalmologic disease or condition
Item
you have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/- six diopters of myopia, retinal detachment, exudative age-related macular degeneration).
boolean
C0015397 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Previously diagnosed amblyopia in the affected eye
Item
you have amblyopia (lazy eye) in affected eye, previously diagnosed.
boolean
C0002418 (UMLS CUI [1,1])
C0449642 (UMLS CUI [1,2])
C0332132 (UMLS CUI [1,3])
Participation in other intenventional clinical trial
Item
you are participating in any other interventional clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C3274035 (UMLS CUI [1,2])
Pregnancy | Absence of medically acceptable means of birth control in women of childbearing potential | Unwilling to perform a pregnancy test
Item
if you are pregnant or a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration or woman unwilling to perform a pregnancy test at study entry/screening.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0032976 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Unable to give informed consent
Item
you are unable to give signed consent due to memory, medical, communication, language, or mental health problems.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Age
Item
you are less than 18 years old.
boolean
C0001779 (UMLS CUI [1])
Unable or unwilling to complete questionnaires or evaluation
Item
you are unable or unwilling to complete the evaluation or questionnaire.
boolean
C0034394 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0220825 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0220825 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Visual acuity
Item
visual acuity better than 20/40
boolean
C0042812 (UMLS CUI [1])
Inability to detect phosphenes during threshold detection
Item
inability to detect phosphenes during threshold detection
boolean
C1709528 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0449864 (UMLS CUI [1,3])
C1511790 (UMLS CUI [1,4])
Medical history of epilepsy | Seizure medications
Item
you are on seizure medications, or have a history of epilepsy.
boolean
C0014544 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
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