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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT06582732
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson
* Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam.
* Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye.
* Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site
Exclusion Criteria:
* Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
* Active ocular inflammation, infection or edema
* Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06582732
Study Brief:
Protocol Section:
NCT06582732