Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-13

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Open Angle Glaucoma Pseudoexfoliation Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Trabeculopuncture

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

Group Type EXPERIMENTAL

Trabeculopuncture

Intervention Type DIAGNOSTIC_TEST

Trabeculopuncture is performed with a Nd:YAG laser on the trabecular meshwork. Four punctures are created along the 180° nasal trabecular meshwork.

Interventions

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Trabeculopuncture

Trabeculopuncture is performed with a Nd:YAG laser on the trabecular meshwork. Four punctures are created along the 180° nasal trabecular meshwork.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No