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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Lens removal by Phacoemulsification
Laser application in trabecular meshwork
Nova Scotia Health
Halifax, Nova Scotia, Canada
RECRUITINGMedication-free intraocular pressure control
Proportion of subjects without use of intraocular pressure lowering medications
Time frame: 2 years
Medication-free intraocular pressure control
Proportion of subjects without use of intraocular pressure lowering medications
Time frame: 10 years
Intraocular pressure change from baseline
Time frame: 10 years
Number of intraocular pressure lowering medications
Time frame: 10 years
Time to introduction of intraocular pressure lowering medications
Time frame: 10 years
Number of adverse effects
Time frame: 10 years
Score at the Glaucoma Quality of Life - 15
The questionnaire GQL-15 was described in PMID: 12671469. The minimum value is 15 and the maximum is 75, with lower values indicating better quality of life.
Time frame: 10 years
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