Evaluation of Minimal Invasive Glaucoma Surgery

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Device: Preserflo®; Procedure: Trabeculectomy; Device: XEN®

• Registration Number: NCT04572880
• Lead Sponsor: Medical University of Graz

Brief Summary

Glaucoma is a neurodegenerative disease with an accelerated and progressiv retinal ganglion cell loss and concomitant visual field defects. Glaucoma can be treated with eye drops, laser therapy or surgery. Various surgical approaches to lower intraocular pressure are available, amongst which trabeculectomy is the gold standard. Recently minimal invasive glaucoma surgery has been introduced and has become a good alternative to trabeculectomy. Randomized clinical trials investigating the postoperative outcomes of various types of glaucoma surgery are limited.

Detailed Description

150 Patients will be randomized to one of the 3 surgeries. Trabeculectomy Preserflo® or Xen® will be done according to a standard protocol Data will be collected for 5 years after surgery, Visual Acuity, Applanation Tonometry, Slit lamp Biomicroscopy, Endothelial cell cound, visual fields, optical coherence tomography of the optic disc, retina and anterior segment, impression cytology and life quality will be done on day of enrollment and during followup. Mean Intraocular pressure and number of glaucoma medications, Endothelial cell loss, visual acuity, visual fields and assessment of life quality will be assessed during the post-operative follow-ups at one week, one month, 3 months, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery.

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-01
• Study Start: 2021-12-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patiens with glaucoma in which surgery is indicated to reach target intraocular pressure
• Subjects not anticipated to require any further surgery in the next 12 months

Exclusion Criteria

• Patients who do not want to make follow-ups at the department
• angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrom, Axenfeld-Rieger syndrom.
• Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation
• Any major ocular inflammation up to 30 days prior to surgery
• Conjunctival scarring
• Allergy to any drugs required for the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preserflo®	Preserflo®	-
Trabeculectomy	Trabeculectomy	-
XEN®	XEN®	-

Primary Outcome Measures

Name	Time	Method
Mean intraocular pressure	up to 5 years post surgery	Goldmann Applanation Tonometry \[mmHg\]

Secondary Outcome Measures

Name	Time	Method
Number of medications	up to 5 years post surgery	antihypertensive eye-drops

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria