XEN Glaucoma Gel Stent Versus Trabeculectomy
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
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
Treatments tested in this trial
- surgery
Treatment groups
196 Participants
are divided into 2 treatment groupsSponsors and collaborators
Prof. Dr. Herbert Reitsamer
Lead sponsor
Paracelsus Medical University
Sponsor institution
Source ClinicalTrials.gov