Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT02526693
Eligibility Criteria:
Inclusion Criteria:
Glaucoma patients:
* optic nerve damage (neuroretinal rim notch, asymmetric inter-eye cup to disc (c/d\_ ratio \>0.2 or disc damage likelihood scale (DDLS) \>2, or absence of neuroretinal rim not due to other cause)
* glaucomatous visual field (VF) deficits (cluster of 3 or more points on pattern deviation plot depressed below 5% level, at least 1 depressed below 1% level; OR corrected pattern standard deviation/pattern standard deviation significant at P \<0.05; or glaucoma hemifield test "outside normal limits") with good reliability indices (fixation losses, false-positive rate, false-negative rate each \< 33%).
Healthy subjects:
* normal optic nerve exam
* normal reliable VF (Humphrey mean deviation (MD) \>-2 or Octopus MD ≤0.8; fixation losses, false-positive rate, and false-negative rate each \< 33%)
* open angles gonioscopy.
Exclusion Criteria:
* Abnormal ocular motility preventing binocular fixation (e.g. strabismus, nystagmus).
* Any condition preventing adequate visualization and examination of pupil or optic nerve (e.g. dense corneal opacities or lens opacities).
* Active infection of anterior or posterior segments of the eye.
* Any intraocular surgical or laser procedure within previous 4 weeks.
* Any non-glaucomatous condition causing RAPD, anisocoria or corectopia (ex. optic neuropathy, Horner's syndrome, previous iris injury due to trauma or surgery, etc.).
* Subjects under age 18 or subjects presently housed in correctional facility.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02526693
Study Brief:
Protocol Section:
NCT02526693