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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT05439161
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
2. Clinically eligible for both surgeries (Trabeculectomy and XEN) on the discretion of the surgeon (area of healthy, free and mobile conjunctiva in the superior nasal target quadrant)
3. VA logMAR ≤ 1 (VA dec ≥ 0.1)
4. Trabecular meshwork must be visible (with Shaffer angle grade \> 1 in the target quadrant)
5. Age 18 years or older
6. Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent
Exclusion Criteria:
1. Clinical significant cataract
2. Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
3. Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.
4. Phacic Angle Closure Glaucoma
5. Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
6. Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
7. Anterior chamber intraocular lens
8. Vitreous present in the anterior chamber
9. Presence of intraocular silicone oil
10. History of corneal surgery, corneal opacities, or corneal disease
11. Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos)
12. History of dermatologic keloid formation
13. Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, or other ophthalmic disease or disorder that could confound study results
14. Known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde),
15. Pregnant or nursing women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05439161
Study Brief:
Protocol Section:
NCT05439161