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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07358650
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 40 years with uncontrolled mild to moderate POAG.
* IOP ≥ 18 mmHg on ≥1 topical IOP-lowering medications.
* Open angle on gonioscopy
* Clear cornea and healthy ocular surface
* Capable of giving informed consent, willingness to participate in the trial, and adhering to follow-up
* Glaucomatous visual field loss in one or both eyes at presentation on any of these criteria:
* Reproducible and reliable visual field defects on 2 consecutive fields
* Mild, moderate or advanced disease on mean deviation according to Hodapp classification
* Healthy, mobile conjunctiva in the target quadrant (superior bulbar region)
* Best-corrected Snellen visual acuity of 20/100 or better
* Visual field mean deviation no worse than -18.0 dB (without dense paracentral scotomas)
* No anticipated need for other ocular surgeries (e.g., cataract) within 3 months of post-enrollment
Exclusion Criteria:
* Prior glaucoma filtering surgery (trabeculectomy, shunt or valve) in the treatment quadrant
* Angle-closure, neovascular, uveitic, or traumatic glaucoma.
* Eyes with conjunctival scarring, prior conjunctival surgery or other pathologies in the treatment quadrant
* Eyes with scleral thinning, staphyloma, or structural abnormalities in the treatment quadrant
* Uncontrolled IOP \> 35 mmHg at screening.
* Active ocular infection or inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis).
* Active or recent (within 6 months) iris neovascularization in the treatment quadrant
* Impaired episcleral venous drainage
* Anterior chamber intraocular lens
* Patients with uncontrolled bleeding disorders or those receiving anticoagulation therapy without appropriate perioperative management
* Advanced glaucomatous optic neuropathy.
* Fuchs endothelial dystrophy with clinical signs of endothelial decompensation.
* Central corneal thickness (CCT) \> 600 μm.
* Pathological myopia.
* Patients unable to comply with postoperative follow-up or treatment instructions
* Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception as outlined below are excluded:
* Hormonal methods and the intrauterine device (IUD) must be in use at least 30 days prior to first study drug administration
* Barrier methods must be in use at least 14 days prior to study drug administration
* Your male partner vasectomy must be completed 3 months prior to first study drug administration or a sperm count of 0 should be confirmed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT07358650
Study Brief:
Protocol Section:
NCT07358650