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Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

W

Wuerzburg University Hospital

Status

Enrolling

Conditions

Open Angle Glaucoma
Pseudoexfoliation Glaucoma

Treatments

Diagnostic Test: Trabeculopuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06523751
IRB 113-21-me

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

Trabeculopuncture
Experimental group
Description:
Individuals undergo neodymium-doped yttrium aluminum garnet (Nd:YAG) trabeculopuncture prior to ab interno trabeculectomy.
Treatment:
Diagnostic Test: Trabeculopuncture

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Raoul Verma-Fuehring, MD

Data sourced from clinicaltrials.gov

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