CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Trabeculectomy surgeryprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06000280
NCT06000280N/ACompleted

Evaluation of Macular Thickness in Patients With Glaucoma in Use of Topical Prostaglandin Analogue Undergoing Trabeculectomy With Mitomycin C

Universidade Federal de Goias·interventional·Posted Aug 21, 2023·Updated Aug 22, 2023

In Brief

A clinical study evaluating Trabeculectomy surgery for Glaucoma. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The aim of this study was to verify whether prostaglandin analogue (PA) eye drops influence the retinal thickness of glaucomatous patients undergoing trabeculectomy (TRAB) surgery. We selected eyes of patients with glaucoma with surgical indication for TRAB who were using PA eye drops and without previous retinal alterations, from the Centro de Referência em Oftalmologia (CEROF) from the Federal University of Goiás and Fundação Banco de Olhos de Goiás (FUBOG). Patients were divided into 2 groups: the study group (SG) and the control group (CG). In the CG, the PA was suspended between 30 and 60 days before the preoperative exams were performed (maximum of 15 days before surgery for both groups). All patients included were submitted to various eye exams before the procedure, and postoperatively on 3 occasions: 1 to 3 days ("PO1"), 6 to 9 days ("PO7") and 27 to 30 days ("PO30") after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 21, 2023
Enrollment StartJan 4, 2021
Primary CompletionFeb 28, 2023
Study CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 2.9 years ago

Interventions

Trabeculectomy surgeryprocedure

The Trabeculectomy aims to create a permanent drainage outflow channel for the aqueous humor, connecting the anterior chamber to the sub-Tenon's space, using mitomycin C consisted of opening the conjunctival base of the fornix and applying mitomycin C 0.4 mg/ml for 2 minutes. The trabeculectomy techniques require controlled outflow of aqueous humor through a sclerostomy and a partial-thickness scleral flap to form a subconjunctival bleb. The protected strength of the flap, with or without sutures, and the strength of the episcleral tissue determine the final IOP.