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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01957267
Eligibility Criteria:
Inclusion Criteria: Normal Subjects (both eyes must meet all criteria)
1. No history or evidence of retinal pathology or glaucoma
2. Normal Humphrey 24-2 VF: A mean defect (MD), corrected pattern standard deviation (CPSD) within 95% limits of normal reference, and glaucoma hemifield test (GHT) within normal limits (97%).
3. Intraocular pressure \< 21 mm Hg
4. Central corneal pachymetry \> 500 microns
5. No chronic ocular or systemic corticosteroid use
6. Open angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system)
7. Normal appearing ONH and NFL: vertical and horizontal cup/disc ratio (CDR) ≤ 0.5 and intact neuroretinal rim without peripapillary hemorrhages, notches, localized pallor, or NFL defect
8. Symmetric ONH between left and right eyes: CDR difference \< 0.2 in both vertical and horizontal dimensions
Inclusion criteria: Glaucoma Group
1. ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following:
1. diffuse or localized thinning of the rim
2. disc (splinter) hemorrhage
3. notch in the rim
4. vertical cup/disc ratio greater than the fellow eye by \> 0.2
2. Presence or absence of VF defects as measured by Humphrey SITA 24-2 VF.
Exclusion Criteria: All Groups
1. Best-corrected visual acuity less than 20/40
2. Age \< 40 or \>85 years
3. Refractive error of \> +3.00 D or \< -7.00 D
4. Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation
5. Diabetic retinopathy
6. Other diseases that may cause VF loss or optic disc abnormalities
7. Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
8. Inability to perform reliably on automated VF testing
9. Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.
10. Refusal of informed consent or of commitment to the full length of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT01957267
Study Brief:
Protocol Section:
NCT01957267