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RECRUITING
NCT04416724
NA

Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

Sponsor: Nova Scotia Health Authority

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2022-10-10

Completion Date

2033-08

Last Updated

2024-08-21

Healthy Volunteers

No

Interventions

PROCEDURE

Phacoemulsification

Lens removal by Phacoemulsification

DEVICE

Selective Laser Trabeculoplasty

Laser application in trabecular meshwork

Locations (1)

Nova Scotia Health

Halifax, Nova Scotia, Canada