Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

Study Overview
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Brief Summary
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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.

Official Title
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Canadian Pseudoexfoliation Glaucoma Trial: Comparison of Phacoemulsification Versus Selective Laser Trabeculoplasty as Initial Treatment for Pseudoexfoliation Glaucoma

Conditions
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Pseudoexfoliation Glaucoma

Intervention / Treatment
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* Procedure: Phacoemulsification
* Device: Selective Laser Trabeculoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phacoemulsification<br>Main study intervention will be Phacoemulsification | Procedure: Phacoemulsification<br>* Lens removal by Phacoemulsification<br>|
| Experimental: SLT<br>Main study intervention will be Selective Laser Trabeculoplasty | Device: Selective Laser Trabeculoplasty<br>* Laser application in trabecular meshwork<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication-free intraocular pressure control | Proportion of subjects without use of intraocular pressure lowering medications | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication-free intraocular pressure control | Proportion of subjects without use of intraocular pressure lowering medications | 10 years | 
| Intraocular pressure change from baseline |  | 10 years | 
| Number of intraocular pressure lowering medications |  | 10 years | 
| Time to introduction of intraocular pressure lowering medications |  | 10 years | 
| Number of adverse effects |  | 10 years | 
| Score at the Glaucoma Quality of Life - 15 | 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. | 10 years |