Actively Recruiting
XEN Glaucoma Gel Stent Versus Trabeculectomy
Led by Prof. Dr. Herbert Reitsamer · Updated on 2025-06-03
196
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects
CONDITIONS
Official Title
XEN Glaucoma Gel Stent Versus Trabeculectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Visual acuity logMAR = 1 (visual acuity decimal 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 will not qualify if you...
- Clinically significant cataract
- Prior cataract surgery in study eye within 1 month before operation
- Prior incisional glaucoma surgery (e.g., XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts, collagen implants)
- Phacic angle closure glaucoma
- Neovascular, uveitic, or angle recession glaucoma or glaucoma associated with vascular disorders
- Active eye inflammation (blepharitis, conjunctivitis, keratitis, uveitis)
- Presence of 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, retinal vein occlusion, or other eye disorders that may affect results
- Known or suspected allergy to drugs or device components used in surgery (e.g., porcine products or glutaraldehyde)
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dept. Ophthalmology and Optometry Paracelsus Medical University
Salzburg, Austria, 5020
Actively Recruiting
Research Team
M
Markus Lenzhofer, MD PhD
CONTACT
H
Herbert Reitsamer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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