RecruitingNot Applicable

XEN Glaucoma Gel Stent Versus Trabeculectomy

Austria196 participantsStarted 2023-12-20

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
✓. 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)
✓. VA logMAR ≤ 1 (VA dec ≥ 0.1)
✓. Trabecular meshwork must be visible (with Shaffer angle grade \> 1 in the target quadrant)
✓. Age 18 years or older
✓. Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent

✕. Clinical significant cataract
✕. Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
✕. Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.
✕. Phacic Angle Closure Glaucoma
✕. Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
✕. Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
✕. Anterior chamber intraocular lens
✕. Vitreous present in the anterior chamber

Best Corrected Distance Visual Acuity at 1 Week

Timeframe: Week 1

NCT IDNCT05439161

SponsorProf. Dr. Herbert Reitsamer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

Markus Lenzhofer, MD PhD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)
✓. 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)
✓. VA logMAR ≤ 1 (VA dec ≥ 0.1)
✓. Trabecular meshwork must be visible (with Shaffer angle grade \> 1 in the target quadrant)
✓. Age 18 years or older
✓. Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent

✕. Clinical significant cataract
✕. Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)
✕. Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.
✕. Phacic Angle Closure Glaucoma
✕. Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
✕. Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
✕. Anterior chamber intraocular lens
✕. Vitreous present in the anterior chamber