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:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02609204
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers age 18 years
* older with normal eye exam
Exclusion Criteria:
* spherical refraction outside + 5.0 Diopters and cylinder correction outside + 3.0 Diopters.
* IOP (intraocular pressure) ≥ 22 mm Hg (millimeters of mercury)
* history of any type of glaucoma in either eye.
* Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment).
* Best corrected visual acuity worse than 20/40.
* Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye.
* Evidence of optic nerve, macula and/or retinal nerve fiber layer abnormality in either eye.
* Evidence of reproducible (false positives, fixation losses and false negatives ≤ 25% with no observable testing artifacts).
* Standard Automatic Perimetry (SAP) abnormality in either eye, defined as Pattern Standard Deviation \< 5% level, and/or abnormal Glaucoma Hemifield test result, and/or any other pattern of loss which is consistent with a neurologic and/or ocular disease.
* Current or recent (within the past 30 days) use of an agent (by any administering method) known to affect visual function.
* Inability to obtain reliable PERG/FERG (Pattern Electroretinogram/Flash Electroretinogram) results.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02609204
Study Brief:
Protocol Section:
NCT02609204