XEN Gel Stent Compared With Trabeculectomy for Glaucoma Eye Surgery
Compares a small gel stent with standard surgery in adults with open angle glaucoma.
Plain-language title generated from the registry record
Registry title: XEN Glaucoma Gel Stent Versus Trabeculectomy
Key facts
- Where
- Salzburg, AustriaSee the site
Where in Austria
- Dept. Ophthalmology and Optometry Paracelsus Medical UniversitySalzburg, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prof. Dr. Herbert Reitsamer
- Trial code
- NCT05439161
- Record updated
- 3 June 2025
- Original description
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjectsRead full original descriptionShow less
Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects
Inclusion: 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.
Exclusion: Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable; Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders; History of corneal surgery, corneal opacities, or corneal disease; 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),; Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation); Clinical significant cataract; Phacic Angle Closure Glaucoma; Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis); Anterior chamber intraocular lens; Vitreous present in the anterior chamber; Presence of intraocular silicone oil; Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos); Pregnant or nursing women.