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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT04503356
Eligibility Criteria:
Inclusion Criteria:
* diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma
* 0-3 topical ocular hypotensive medications at preoperative baseline. Fixed combinations counted as number of components
* Open angles (Shaffer grade ≥3)
* early or moderate glaucoma (based on visual field)
* Subjects with a combined procedure should have had uncomplicated cataract surgery (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence of zonular dehiscence or rupture, well centered IOL)
Exclusion Criteria:
* Any of the following prior treatments for glaucoma:
* Suprachoroidal stent
* Laser trabeculoplasty ≤6 months prior to OMNI procedure
* Trabecular bypass implanted ≤6 months prior to OMNI procedure
* Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve
* Prior canaloplasty, goniotomy, or trabeculotomy
* Forms of glaucoma other than OAG including: acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
* Under treatment with oral carbonic anhydrase inhibitor at the preoperative visit
* Clinically significant ocular pathology, other than age-related cataract and glaucoma. (e.g. wet AMD, uveitis, corneal edema, proliferative diabetic retinopathy, optic neuritis in medical history)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04503356
Study Brief:
Protocol Section:
NCT04503356