NCT06865235

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Faculdade de Ciências Médicas de Minas Gerais · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-05-07
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-03-07
• Last updated: 2025-03-07

Locations

1 site across 1 country: Brazil