Clinical trial NCT06523751: Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy
Official title: Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Keywords: Ab Interno Trabeculectomy
Trabeculopuncture
Open Angle Glaucoma
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
Primary purpose: DIAGNOSTIC

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.

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.

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)

Primary outcomes:
measure: IOP
timeFrame: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
measure: Outflow facility
timeFrame: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
measure: Surgical success
timeFrame: at month three
Secondary outcomes:
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Uniklinikum Würzburg
state: Bavaria
Study officials:
affiliation: Department of Ophthalmology University Hospital Würzburg
name: Daniel Kampik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.