Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma
- Conditions
- Pseudoexfoliation Glaucoma
- Interventions
- Device: Selective Laser TrabeculoplastyProcedure: Phacoemulsification
- Registration Number
- NCT04416724
- Lead Sponsor
- Nova Scotia Health Authority
- 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) - 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SLT Selective Laser Trabeculoplasty Main study intervention will be Selective Laser Trabeculoplasty Phacoemulsification Phacoemulsification Main study intervention will be Phacoemulsification
- Primary Outcome Measures
Name Time Method Medication-free intraocular pressure control 2 years Proportion of subjects without use of intraocular pressure lowering medications
- Secondary Outcome Measures
Name Time Method Medication-free intraocular pressure control 10 years Proportion of subjects without use of intraocular pressure lowering medications
Number of adverse effects 10 years Time to introduction of intraocular pressure lowering medications 10 years Intraocular pressure change from baseline 10 years Number of intraocular pressure lowering medications 10 years Score at the Glaucoma Quality of Life - 15 10 years 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.
Trial Locations
- Locations (1)
Nova Scotia Health
🇨🇦Halifax, Nova Scotia, Canada