Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

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.

NCT Number	NCT04416724
Lead Sponsor	Nova Scotia Health Authority Collaborators: Glaucoma Research Society of Canada, Canadian Glaucoma Society
Conditions	Pseudoexfoliation Glaucoma
Enrollment	200 participants
Start Date	2022-10-10
Primary Completion	2025-08 (estimated)
Study Completion	2033-08 (estimated)
Updated on ClinicalTrials.gov	2024-08-21