Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

Not Applicable

Recruiting

• Conditions: Open Angle Glaucoma; Pseudoexfoliation Glaucoma
• Interventions: Diagnostic Test: Trabeculopuncture

• Registration Number: NCT06523751
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.

Detailed Description

The aim of this study is to develop a non-invasive predictive test for the function of the distal outflow tract after ab interno trabeculectomy for open angle glaucoma. We hypothesize that the ocular pressure drop and outflow change after preoperative trabeculectomy may predict the success of ab interno trabeculectomy. The results of this study should allow trabeculopuncture to be used to select the most appropriate procedure for the individual patient.

Study Timeline

• Study Start: 2023-06-13
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• individuals ≥ 18 years of age
• clinical diagnosis of: primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma
• uncontrolled intraocular pressure (IOP) with maximally tolerated medical therapy
• progressive thinning of retinal nerve fiber layer assessed by Spectral domain optical coherence tomography (p < 0.05)
• progression of visual field defects
• visually significant cataract and indication to reduce IOP or glaucoma medication burden

Exclusion Criteria

• clinical diagnosis of neovascular glaucoma, angle-closure glaucoma, uveitic glaucoma, neovascular glaucoma
• prior glaucoma surgery
• preexisting conditions affecting the episcleral venous pressure including Grave's ophthalmopathy, Sturge-Weber syndrome, Arteriovenous fistulas (carotid-cavernous fistula)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trabeculopuncture	Trabeculopuncture	Individuals undergo neodymium-doped yttrium aluminum garnet (Nd:YAG) trabeculopuncture prior to ab interno trabeculectomy.

Primary Outcome Measures

Name	Time	Method
IOP	before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively	Intraocular pressure measured by Goldmann applanation tonometry
Outflow facility	before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively	Outflow facility is measured by the use of a pneumatonometer
Surgical success	at month three	surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops

Trial Locations

Locations (1)

Uniklinikum Würzburg; 🇩🇪 Würzburg, Bavaria, Germany