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Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract.

NCT06865235 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-03-07

No results posted yet for this study

Summary

Prospective, randomized, , double-blind, clinical trial, comparing the variation of intraocular pressure (IOP) of patients with mild or moderate primary open-angle glaucoma (OAG) and cataract divided into three groups. All study participants should be treated for the pathology with one or more hypotensive medications or, regardless of the number of drugs, when IOP is greater than 20 mmHg and less than 26 mmHg. The two-year follow-up should also compare the reduction in the number of medications used, reoperation rate, adverse effects, visual acuity, endothelial loss, induction of astigmatism, variation in IOP according to axial diameter of the eye, anterior chamber and age, in addition to the existence of change in the quality of life of patients in the postoperative period

Conditions

  • Open Angle Glaucoma (OAG)

Interventions

PROCEDURE

360º goniotomy assisted transluminal trabeculotomy

Open the Schlemm Canal for 360º with a polipropilen 5-0 suture via trabecular meshwork.

PROCEDURE

Phacoemulsification

Cataract Surgery

PROCEDURE

180º gonioscopy assisted transluminal trabeculotomy

Open the Schlemm Canal for 180º with a polipropilen 5-0 suture via trabecular meshwork.

Sponsors & Collaborators

  • Hospital Evangélico de Belo Horizonte

    collaborator UNKNOWN

  • Faculdade de Ciências Médicas de Minas Gerais

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06865235 on ClinicalTrials.gov