Actively Recruiting
Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects
Led by Prof. Dr. Herbert Reitsamer · Updated on 2025-06-03
196
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of filtering glaucoma surgeries—XEN implant standalone procedure and classic trabeculectomy standalone procedure—in patients with open angle glaucoma. This prospective, randomized, multicenter trial aims to compare postoperative best corrected visual acuity and refraction between these two standard surgical treatments. The study includes subjects eligible for both procedures and excludes those needing combined cataract surgery. Up to 196 eyes will be enrolled across four centers in Europe. Participants will be randomly assigned to receive either the XEN Glaucoma Gel Microstent implant, a minimally invasive surgery that preserves conjunctiva, or the classic trabeculectomy, a more invasive ab externo procedure considered the gold standard. Both groups follow the same inclusion and exclusion criteria, with no inclusion of both eyes from the same patient. Postoperative ophthalmic evaluations will be conducted at specified times to monitor recovery and outcomes. During the study, participants will have preoperative screening and visits scheduled at operation day, 1 day, 1 week, 2 weeks, then 1, 3, 6, and 12 months post-surgery. Assessments include measuring best corrected distance and near visual acuity, refraction changes, and safety and efficacy of both surgeries. The primary outcome is the proportion of patients with a best corrected distance visual acuity better than 0.3 logMAR at 1 week. Secondary outcomes include visual acuity changes and recovery time at other postoperative visits.
CONDITIONS
Brief 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)
- Best corrected visual acuity (VA) logMAR 1 (VA 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 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 such as XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts, collagen implants, etc. (prior iridotomy allowed)
- Phacic Angle Closure Glaucoma
- Neovascular, uveitic, angle recession glaucoma or glaucoma associated with vascular disorders
- Active inflammation (blepharitis, conjunctivitis, keratitis, uveitis)
- Presence of anterior chamber intraocular lens
- Vitreous present in anterior chamber
- Presence of intraocular silicone oil
- History of corneal surgery, corneal opacities, or corneal disease
- Impaired episcleral venous drainage (e.g., Sturge-Weber syndrome, nanophthalmos)
- History of dermatologic keloid formation
- Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch or central retinal vein occlusion, or other ophthalmic diseases that could affect study results
- Known or suspected allergy or sensitivity to drugs or device components used in surgery (e.g., porcine products, glutaraldehyde)
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for preoperative evaluation including medical history and ocular assessment
Duration - 1 day
Participants undergo one of two types of filtering glaucoma surgeries: the XEN implant or classic trabeculectomy, both performed as standalone procedures.
Operative visit and 1 day post-operative visit (in-person)
Duration - Up to 12 months
Participants attend scheduled post-operative visits to monitor visual acuity, refraction, efficacy, and safety of the surgery.
Visits at 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months post-surgery (in-person)
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
H
Herbert Reitsamer, MD
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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