Status:
RECRUITING
Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Glaucoma Research Society of Canada
Canadian Glaucoma Society
Conditions:
Pseudoexfoliation Glaucoma
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material on anterior capsule, pupil, or anterior chamber angle
- Clinical decision to lower the IOP, as assessed by the investigator who is treating the subject, based on the presence of PXG or with IOP elevated enough to warrant treatment, even without clear evidence of optic nerve damage or visual field defect
- Presence of asymptomatic early cataract
Exclusion
- Age less than 50 years old
- Anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum visible in less than 180º
- Previous IOP lowering procedure such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery
- Previous use of IOP lowering medication for more than 6 months
- Presence of ocular or systemic pathology or medication that could significantly influence the IOP, such as: uveitis, neovascular or traumatic glaucoma, corneal pathology influencing tonometry, use of oral steroids
- IOP at baseline visit higher than 36 mmHg
- Visual field damage at baseline visit with mean deviation worse than -15 dB
- Not able or willing to provide voluntary, informed consent to participate in the study
Key Trial Info
Start Date :
October 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2033
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04416724
Start Date
October 10 2022
End Date
August 1 2033
Last Update
August 21 2024
Active Locations (1)
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1
Nova Scotia Health
Halifax, Nova Scotia, Canada, B3H 2Y9