Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

NCT06523751 | Recruiting

• 1 other identifier: IRB 113-21-me
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma; Pseudoexfoliation Glaucoma

Keywords

Ab Interno Trabeculectomy; Trabeculopuncture; Open Angle Glaucoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Trabeculopuncture

EXPERIMENTAL

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

Diagnostic Test: Trabeculopuncture

Interventions

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.

Trabeculopuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

Uniklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 35732782 BACKGROUND

• 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.

  PMID: 4022580 BACKGROUND

• 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.

  PMID: 3977666 BACKGROUND

• 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.

  PMID: 3173993 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Iris Diseases; Uveal Diseases

Study Officials

• Daniel Kampik, MD, PhD

  Department of Ophthalmology University Hospital Würzburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raoul Verma-Fuehring, MD

CONTACT

+49 93120120662; vermafuehr_R@ukw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 26, 2024
• Study Start: June 13, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)