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Recruiting NCT06523751

Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

No phase Interventional Open Angle Glaucoma Pseudoexfoliation Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trabeculopuncture.
Who it may be relevant to
Registry conditions: Open Angle Glaucoma, Pseudoexfoliation Glaucoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • IOP [Time frame: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively]
  • Outflow facility [Time frame: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively]
  • Surgical success [Time frame: at month three]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Germany · 1 center
  • Uniklinikum Würzburg — Würzburg

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. PMID 35732782
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06523751 · IRB 113-21-me

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗