Actively Recruiting
Canadian Pseudoexfoliation Glaucoma Trial: Comparing Phacoemulsification and Selective Laser Trabeculoplasty as Initial Treatments
Led by Nova Scotia Health Authority · Updated on 2024-08-21
200
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
N
Nova Scotia Health Authority
Lead Sponsor
G
Glaucoma Research Society of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two initial treatment options for patients newly diagnosed with pseudoexfoliation glaucoma who need to lower their intraocular pressure (IOP). This randomized clinical trial compares Selective Laser Trabeculoplasty (SLT), a laser treatment targeting the eye's drainage system, and Phacoemulsification (PHACO), a procedure that removes the lens. The study focuses on patients who also have early, symptom-free lens clouding and aims to determine which treatment better controls IOP without medication over two years. Participants will be randomly assigned to receive either the PHACO procedure or SLT. Those who do not reach their target IOP with the initial treatment will then receive medication to lower IOP. The study follows guidelines from the Canadian Ophthalmological Society for managing glaucoma. Longer-term outcomes will be assessed through chart reviews at five and ten years after treatment. During the study, patients will be monitored regularly for two years to assess their IOP control without medication as the main outcome. Secondary measures include changes in IOP, timing of medication use, visual function reported by patients, and any side effects. The research team will also review records at 5 and 10 years to gather extended follow-up data. Overall participation may last a decade for those involved in long-term monitoring.
CONDITIONS
Brief Title
Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pseudoexfoliation syndrome detected by exfoliative material on the eye during slit-lamp exam
- Clinical decision to lower intraocular pressure based on pseudoexfoliation glaucoma or elevated IOP
- Presence of early, asymptomatic cataract
You will not qualify if you...
- Age less than 50 years
- Anterior chamber angle closure with less than 180° pigmented trabeculum visible
- Previous eye pressure lowering procedures such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery
- Previous use of IOP lowering medication for more than 6 months
- Eye or systemic conditions or medications affecting IOP, including uveitis, neovascular or traumatic glaucoma, corneal problems, or oral steroids
- Baseline intraocular pressure higher than 36 mmHg
- Visual field damage worse than -15 dB mean deviation
- Unable or unwilling to give informed consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up as needed
Participants receive either Phacoemulsification (lens removal) or Selective Laser Trabeculoplasty (laser application) as initial treatment for pseudoexfoliation glaucoma.
1 treatment visit plus follow-up visits depending on assigned intervention
Duration - Up to 10 years
Participants are monitored for medication-free intraocular pressure control and other outcomes up to 10 years after treatment.
Regular visits scheduled over 10 years
Trial Site Locations
Total: 1 location
1
Nova Scotia Health
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
Research Team
M
Marcelo Nicolela, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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