XEN Glaucoma Gel Stent Versus Trabeculectomy

NCT05439161 | Recruiting DMC

• 1 other identifier: A.08242018-v2.15122021
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma; Pigmentary Dispersion Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 1

Study Arms (2)

XEN Glaucoma Gel Microstent (AbbVie) Device

ACTIVE COMPARATOR

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.

Device: surgery

Trabeculectomy

ACTIVE COMPARATOR

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).

Device: surgery

Interventions

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

Trabeculectomy; XEN Glaucoma Gel Microstent (AbbVie) Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Herbert Reitsamer: lead

Study Sites (1)

Dept. Ophthalmology and Optometry Paracelsus Medical University

Salzburg, 5020, Austria

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Exfoliation Syndrome

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Iris Diseases; Uveal Diseases

Study Officials

• Herbert Reitsamer, MD

  Paracelsus Medical University Salzburg/ Salzburger Landeskliniken

  STUDY CHAIR

Central Study Contacts

Markus Lenzhofer, MD PhD

CONTACT

+43 5 7255; m.lenzhofer@salk.at

Herbert Reitsamer, MD

CONTACT

+43 5 7255; h.reitsamer@salk.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Herbert Reitsamer

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 30, 2022
• Study Start: December 20, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)