XEN Glaucoma Gel Stent Versus Trabeculectomy

Recruiting now · Not applicable

Conditions studied: Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Dispersion Glaucoma

In brief

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

Key facts

Study ID

NCT05439161

Run by

Prof. Dr. Herbert Reitsamer

People needed

196

Starts

2023-12-20

Expected to finish

2026-09-30

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Presence of intraocular silicone oil
• History of corneal surgery, corneal opacities, or corneal disease
• Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos)
• History of dermatologic keloid formation
• 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
• 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),
• Pregnant or nursing women

Where it is running

• Dept. Ophthalmology and Optometry Paracelsus Medical University — Salzburg, Austria (enrolling)

Full record on ClinicalTrials.gov

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