Comparing XEN Glaucoma Gel Stent and Trabeculectomy for Glaucoma Treatment
Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects
This study is testing whether a new minimally invasive glaucoma implant works better than traditional surgery for improving vision in people with open angle glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Paracelsus Medical University Academic / other |
| Locations | 1 site (Salzburg) |
| Trial ID | NCT05439161 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the XEN implant compared to classic trabeculectomy in improving best corrected visual acuity in patients with open angle glaucoma. It is a multicentric, randomized trial involving up to 196 eyes, where eligible patients will be assigned to either the XEN implant or trabeculectomy group. Both procedures are standard surgical treatments for glaucoma, with the XEN implant being a minimally invasive option that avoids conjunctival dissection. The study aims to gather data on postoperative outcomes to determine which procedure offers better visual acuity results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary open angle glaucoma, pseudoexfoliation glaucoma, or pigmentary dispersion glaucoma who are eligible for both surgical procedures.
Not a fit: Patients with clinically significant cataracts or those requiring combined cataract surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which surgical approach offers better visual outcomes for glaucoma patients.
How similar studies have performed: Previous studies have shown varying success with both surgical approaches, but this specific comparison of the XEN implant versus trabeculectomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salzburg
- Dept. Ophthalmology and Optometry Paracelsus Medical University — Salzburg, Austria (Recruiting)
Study contacts
- Study coordinator: Markus Lenzhofer, MD PhD
- Email: m.lenzhofer@salk.at
- Phone: +43 5 7255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.