NCT04416724

Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

Canadian Pseudoexfoliation Glaucoma Trial: Comparison of Phacoemulsification Versus Selective Laser Trabeculoplasty as Initial Treatment for Pseudoexfoliation Glaucoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The Canadian Pseudoexfoliation Glaucoma Study 1 is a randomized clinical trial that aims to compare two initial treatment options - Selective Laser Trabeculoplasty (SLT) and Phacoemulsification (PHACO) - in newly diagnosed patients with pseudoexfoliation and need to lower the intraocular pressure. Patients with pseudoexfoliation and a recent decision to lower the intraocular pressure, who also have early asymptomatic lens opacification will be recruited and randomized to receive either SLT or PHACO. Patients will be followed for 2 years according to a target IOP protocol based on the Canadian Ophthalmological Society Glaucoma guidelines. Patients who do not achieve the target IOP with the initial randomization procedure will receive IOP lowering medications. The main outcome of interest will be the proportion of subjects who need IOP lowering medications after 2 years. Secondary outcomes include IOP reduction, time to need medications, patient reported outcomes in terms of visual function, and occurrence of adverse effects. To obtain longer follow-up information beyond two years, a chart review will be done 5 and 10 years after randomization.

Conditions

• Pseudoexfoliation Glaucoma

Interventions

Type	Name	Description
PROCEDURE	Phacoemulsification	Lens removal by Phacoemulsification
DEVICE	Selective Laser Trabeculoplasty	Laser application in trabecular meshwork

Timeline

• Start date: 2022-10-10
• Primary completion: 2025-08-01
• Completion: 2033-08-01
• First posted: 2020-06-04
• Last updated: 2024-08-21

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study