RecruitingNot ApplicableNCT06865235

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

Efficacy and Safety of Gonioscopy Assisted Transluminal Trabeculotomy in Patients with Primary Open-angle Glaucoma and Cataract - a Randomized Clinical Trial

Sponsor

Faculdade de Ciências Médicas de Minas Gerais

Enrollment

90 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Open-angle Glaucoma (OAG)

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

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests a surgical procedure called GATT (gonioscopy-assisted transluminal trabeculotomy) combined with cataract surgery to treat patients who have both glaucoma and cataracts at the same time. **You may be eligible if...** - You are 40 years of age or older - You have been diagnosed with primary open-angle glaucoma (POAG) - You also need cataract surgery (your vision has worsened to a specific level) - You are already being followed at one of the participating eye clinics **You may NOT be eligible if...** - You have a different type of glaucoma (such as angle-closure or secondary glaucoma) - You have had previous glaucoma surgery - You have other serious eye diseases such as macular degeneration or diabetic retinopathy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURE360º goniotomy assisted transluminal trabeculotomy

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

PROCEDUREPhacoemulsification

Cataract Surgery

PROCEDURE180º gonioscopy assisted transluminal trabeculotomy

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

Locations(1)

Instituto de Olhos Ciências Médicas - Faculdade de Ciências Médicas de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

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NCT06865235

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