Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
• 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
Locations
Other Locations
Austria
Dept. Ophthalmology and Optometry Paracelsus Medical University
RECRUITING
Salzburg
Contact Information
Primary
Markus Lenzhofer, MD PhD
m.lenzhofer@salk.at
+43 5 7255
Backup
Herbert Reitsamer, MD
h.reitsamer@salk.at
+43 5 7255
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 196
Treatments
Active_comparator: XEN Glaucoma Gel Microstent (AbbVie) Device
Implantation of XEN Glaucoma Gel Microstent (Device, AbbVie) for the treatment of glaucoma will be performed in this arm. It is a newer filtering glaucoma surgery. XEN Glaucoma Gel Microstent implantation accounts to the filtering glaucoma surgeries.
Active_comparator: Trabeculectomy
Trabeculectomy will be performed in this arm. Trabeculecomy is the classic filtering glaucoma surgery since more than 50 years for the treatment of glaucoma (gold standard within the filtering glaucoma surgery group).
Related Therapeutic Areas
Sponsors
Leads: Prof. Dr. Herbert Reitsamer