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NCT Number: NCT06523751

Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

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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Key information

Conditions

Open Angle Glaucoma Exfoliation Syndrome Eye Diseases Glaucoma Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Pseudoexfoliation Glaucoma Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uniklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location status: Recruiting

Location contact

Raoul Verma-Führing, MD

CONTACT

[email protected]

0049 93120120662

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Trabeculopuncture

Diagnostic Test

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

Primary outcomes

  1. IOP

    Time frame: 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

  2. Outflow facility

    Time frame: 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

  3. Surgical success

    Time frame: at month three

    surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops

Study contacts

Contact information is provided by the study sponsor or research team.

Raoul Verma-Fuehring, MD

CONTACT

[email protected]

+49 93120120662

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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