XEN Glaucoma Gel Stent Versus Trabeculectomy

ConditionsPrimary Open Angle Glaucoma Pseudoexfoliation Glaucoma Pigmentary Dispersion Glaucoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorProf. Dr. Herbert Reitsamer

About this trial

Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Clinical significant cataract

Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)

Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.

Phacic Angle Closure Glaucoma

Trial design

Design model

Parallel

Treatments tested in this trial

surgery
Device
2 types of filtering glaucoma surgeries (classic trabeculectomy as gold standard, and newer XEN glaucoma microstent) are compared against each other in a prospective multicentric randomized study

Treatment groups

196 Participants

are divided into 2 treatment groups

Group A: XEN Glaucoma Gel Microstent (AbbVie) DeviceActive comparator 1 intervention

Group B: TrabeculectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Best Corrected Distance Visual Acuity at 1 Week

The primary endpoint is the proportion of patients with a best corrected distance visual acuity \> 0.3 (logMAR) after 1 week.

Time frame

Week 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prof. Dr. Herbert Reitsamer

Lead sponsor

Paracelsus Medical University

Sponsor institution

Source ClinicalTrials.gov

Apply now