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Surgery
Phacoemulsification vs SLT for Pseudoexfoliation Glaucoma (CANPEX1 Trial)
N/A
Recruiting
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material on anterior capsule, pupil, or anterior chamber angle
Presence of asymptomatic early cataract
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two different treatments, Selective Laser Trabeculoplasty (SLT) and Phacoemulsification (PHACO), in patients with pseudoexfoliation glau
Who is the study for?
This trial is for patients with pseudoexfoliation syndrome, which can be seen during an eye exam. They should need treatment to lower their eye pressure and have an early cataract without symptoms. People who don't meet these specific eye conditions or require different treatments are not eligible.
What is being tested?
The study compares two initial treatments for lowering eye pressure in pseudoexfoliation glaucoma: Selective Laser Trabeculoplasty (SLT) and Phacoemulsification (PHACO). Patients will be randomly assigned to one of the treatments and followed for 2 years, with some monitored up to 10 years.
What are the potential side effects?
Potential side effects may include discomfort from the laser or surgery, temporary increase in eye pressure, inflammation inside the eye, and possible need for additional medications if target pressures aren't met.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with pseudoexfoliation syndrome.
Select...
I have an early-stage cataract without symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Pharmaceutical Preparations
Score at the Glaucoma Quality of Life - 15
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: SLTExperimental Treatment1 Intervention
Main study intervention will be Selective Laser Trabeculoplasty
Group II: PhacoemulsificationExperimental Treatment1 Intervention
Main study intervention will be Phacoemulsification
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phacoemulsification
2019
Completed Phase 4
~1170
Selective Laser Trabeculoplasty
2015
Completed Phase 3
~1050
Find a Location
Who is running the clinical trial?
Glaucoma Research Society of CanadaOTHER
7 Previous Clinical Trials
1,090 Total Patients Enrolled
Canadian Glaucoma SocietyUNKNOWN
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,362 Total Patients Enrolled
Jayme ViannaLead Sponsor