Comparing two treatments for pseudoexfoliation glaucoma
Official title: Canadian Pseudoexfoliation Glaucoma Trial: Comparison of Phacoemulsification Versus Selective Laser Trabeculoplasty as Initial Treatment for Pseudoexfoliation Glaucoma
Run by Nova Scotia Health Authority · NCT04416724 · Data updated 2026-11-12
This study is testing whether a laser treatment or a cataract surgery works better as the first option for people newly diagnosed with pseudoexfoliation glaucoma to lower their eye pressure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Status | Recruiting |
| Started | October 10, 2022 |
| Main results expected | August 2025 |
| Study ends | August 2033 |
| Registry record updated | August 21, 2024 |
| Trial ID | NCT04416724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 50 and older with pseudoexfoliation syndrome and early asymptomatic cataracts who require IOP reduction.
✕Probably not a fit
Patients with a history of previous IOP lowering procedures or significant ocular/systemic conditions affecting IOP may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares Selective Laser Trabeculoplasty (SLT) and Phacoemulsification (PHACO) as initial treatments for patients newly diagnosed with pseudoexfoliation glaucoma who need to lower their intraocular pressure (IOP). Participants will be randomized to receive either SLT or PHACO and will be followed for two years to assess the effectiveness of each treatment in achieving target IOP levels. The primary outcome will be the proportion of patients requiring additional IOP-lowering medications after two years, with secondary outcomes including IOP reduction and patient-reported visual function. The study aims to provide insights into the best initial treatment approach for this condition.
Why it matters
Potential benefit: If successful, this study could help determine the most effective initial treatment for lowering IOP in patients with pseudoexfoliation glaucoma.
How similar studies have gone: Other studies have explored similar treatment comparisons in glaucoma, indicating potential for meaningful insights, though this specific comparison may be novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material on anterior capsule, pupil, or anterior chamber angle 2. 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 3. Presence of asymptomatic early cataract Exclusion Criteria: 1. Age less than 50 years old 2. Anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum visible in less than 180º 3. Previous IOP lowering procedure such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery 4. Previous use of IOP lowering medication for more than 6 months 5. 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 6. IOP at baseline visit higher than 36 mmHg 7. Visual field damage at baseline visit with mean deviation worse than -15 dB 8. Not able or willing to provide voluntary, informed consent to participate in the study
Where it's running
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Nova Scotia Health
Halifax, Nova Scotia, Canada Recruiting
Study contacts
- Study coordinator: Marcelo Nicolela, MD
- Email: nicolela@dal.ca
- Phone: 902-473-2839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.