Comparing XEN Glaucoma Gel Stent and Trabeculectomy for Glaucoma Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Electrical stimulation treatment for visual field defects in glaucoma patients

  This study is testing if a new electrical stimulation treatment can help people with glaucoma keep their vision from getting worse while they continue using their regular eye drops.

  Recruiting Okuvision GmbH · Mainz · NCT06682962

• G01 Eye Drops for Glaucomatous Optic Neuropathy

  This trial tests whether G01 Eye Drops can help people with open-angle glaucoma who also have optic nerve injury.

  Recruiting at 9 sites Phase 2 Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. · Beijing, Beijing Municipality and 8 other locations · NCT07777861

• Additive Physical Activity for Hypothyroidism in Older Women with Glaucoma and Fatty Liver

  We’re testing whether adding a treadmill-based exercise program to standard thyroid treatment helps improve health in older women who have subclinical hypothyroidism, glaucoma, and fatty liver.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07599241

• Lifestyle changes plus nightly CPAP for glaucoma in people with sleep apnea

  This test checks whether adding a low-calorie diet and regular walking to nightly CPAP lowers eye pressure in people with high‑pressure open‑angle glaucoma who also have obstructive sleep apnea and obesity.

  Recruiting Cairo University · Giza, Dokki · NCT07447011

• Direct Selective Laser Trabeculoplasty to reduce glaucoma medications

  This study will try Direct Selective Laser Trabeculoplasty (DSLT) to reduce the number of eye-drop medications in adults with medically controlled primary open-angle glaucoma or ocular hypertension.

  Recruiting The Eye Institute of West Florida · Largo, Florida · NCT07390890

• Hexiris MIST device to lower eye pressure in people with primary open-angle glaucoma

  This trial will test the Hexiris MIST device to see if it lowers eye pressure in adults 40 and older whose primary open-angle glaucoma isn’t controlled by eye drops.

  Recruiting at 5 sites Hexiris Inc · Dieppe, New Brunswick and 4 other locations · NCT07358650

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.