ID

42353

Description

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

Lien

https://clinicaltrials.gov/show/NCT02019927

Mots-clés

Versions (1)
  1. 22/06/2021 22/06/2021 -
Détendeur de droits

Wills Eye United States Department of Defense

Téléchargé le

22 juin 2021

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Eligibility Non-arteritic Anterior Ischemic Optic Neuropathy NCT02019927

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

age

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Age

Type de données

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

Type de données

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

Type de données

boolean

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

Inability to detect phosphenes during threshold detection

Type de données

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

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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