Status:
RECRUITING
XEN Glaucoma Gel Stent Versus Trabeculectomy
Lead Sponsor:
Prof. Dr. Herbert Reitsamer
Conditions:
Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects
Detailed Description
The objective of this study is to evaluate the postoperative best corrected visual acuity and refraction in 2 different filtering glaucoma surgeries: XEN implant standalone procedure versus classic tr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
- 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, branch retinal vein occlusion, central retinal vein occlusion, or other ophthalmic disease or disorder that could confound study results
- Known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde),
- Pregnant or nursing women
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT05439161
Start Date
December 20 2023
End Date
September 30 2026
Last Update
June 3 2025
Active Locations (1)
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1
Dept. Ophthalmology and Optometry Paracelsus Medical University
Salzburg, Austria, 5020