RecruitingNot ApplicableNCT05439161

XEN Glaucoma Gel Stent Versus Trabeculectomy

Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects

Sponsor

Prof. Dr. Herbert Reitsamer

Enrollment

196 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Pigmentary Dispersion Glaucoma

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria15

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

Interventions

DEVICEsurgery

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