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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT01411657
Eligibility Criteria:
Inclusion Criteria:
* age 40 years or older
* must understand and sign the informed consent
* must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
* diagnosis of ischemic optic neuropathy characterized by (a) non-arteritic subtype, including a normal ESR and CRP; (b) syndrome of acute unilateral visual loss with documented optic nerve head edema but without significant pain; (c) a relative afferent papillary defect in the affected eye, and a decrease of best-corrected visual acuity to 20/40 or worse in the affected eye, and detectable loss on visual field testing consistent with nerve fiber visual field defect but retaining measurable residual visual field preservation.
Exclusion Criteria:
* other corneal, lens, optic nerve or retinal disease causing vision loss,
* blind in one eye
* requirement of acyclovir and/or related products during study
* receiving systemic steroids or other immunosuppressive medications.
* pregnant or lactating.
* considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
* on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01411657
Study Brief:
Protocol Section:
NCT01411657