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Recruiting NCT05439161

XEN Glaucoma Gel Stent Versus Trabeculectomy

Trial Parameters

Condition Primary Open Angle Glaucoma
Sponsor Prof. Dr. Herbert Reitsamer
Study Type INTERVENTIONAL
Phase N/A
Enrollment 196
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-12-20
Completion 2026-03-31
Interventions
surgery

Brief Summary

Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects

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. Subjec

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