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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT03758118
Eligibility Criteria:
Inclusion criteria:
1. Acute visual reduction episode from NAION occurring for more than 6 months
2. Typical defects of the visual field evidenced with the Goldmann perimetry or with Humphrey perimetry 30-2
3. Visual acuity not less than 1/10
4. Having suspended any potential neuroprotective therapies (e.g., Coenzyme Q10) for at least 6 months.
Exclusion criteria:
* Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
* Cataract or maculopathy
* Known hypersensitivity to the study product
* Positive history for diseases of the optic nerve (retrobulbar optic neuropathy, glaucoma) or systemic diseases which could preclude the enrolment in the study according to the investigators' judgement
* Pregnant or nursing women, or women of potential childbearing age not using adequate contraception.
* Diabetes, SLE, rheumatoid arthritis, mixed connective tissue disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT03758118
Study Brief:
Protocol Section:
NCT03758118