Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

Determining Distal Outflow Tract Function in Open Angle Glaucoma as a 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.

Study Overview

• Status: Recruiting
• Conditions: Open Angle Glaucoma; Pseudoexfoliation Glaucoma
• Intervention / Treatment: Diagnostic test: Trabeculopuncture

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 Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raoul Verma-Fuehring, MD; Phone Number: +49 93120120662; Email: vermafuehr_R@ukw.de

Study Locations

• Germany
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • Uniklinikum Würzburg
      • Contact: Raoul Verma-Führing, MD; Phone Number: 0049 93120120662; Email: vermafuehr_R@ukw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trabeculopuncture; Individuals undergo neodymium-doped yttrium aluminum garnet (Nd:YAG) trabeculopuncture prior to ab interno trabeculectomy.	Diagnostic test: Trabeculopuncture; Trabeculopuncture is performed with a Nd:YAG laser on the trabecular meshwork. Four punctures are created along the 180° nasal trabecular meshwork.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Investigators: Principal Investigator: Daniel Kampik, MD, PhD, Department of Ophthalmology University Hospital Würzburg

Publications and helpful links

General Publications

• Verma-Fuehring R, Dakroub M, Han H, Hillenkamp J, Loewen NA. Trabeculopuncture as a predictive test of distal outflow resistance in canal-based surgery. Sci Rep. 2022 Jun 22;12(1):10584. doi: 10.1038/s41598-022-13990-9.
• Epstein DL, Melamed S, Puliafto CA, Steinert RF. Neodymium: YAG laser trabeculopuncture in open-angle glaucoma. Ophthalmology. 1985 Jul;92(7):931-7. doi: 10.1016/s0161-6420(85)33932-5.
• Melamed S, Pei J, Puliafito CA, Epstein DL. Q-switched neodymium-YAG laser trabeculopuncture in monkeys. Arch Ophthalmol. 1985 Jan;103(1):129-33. doi: 10.1001/archopht.1985.01050010135037.
• Del Priore LV, Robin AL, Pollack IP. Long-term follow-up of neodymium: YAG laser angle surgery for open-angle glaucoma. Ophthalmology. 1988 Feb;95(2):277-81. doi: 10.1016/s0161-6420(88)33195-7.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Open Angle Glaucoma; Ab Interno Trabeculectomy; Trabeculopuncture
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Ocular Hypertension; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome
• Other Study ID Numbers: IRB 113-21-me

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No