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| Name | Class |
|---|---|
| Glaucoma Research Society of Canada | OTHER |
| Canadian Glaucoma Society | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phacoemulsification | Experimental | Main study intervention will be Phacoemulsification |
|
| SLT | Experimental | Main study intervention will be Selective Laser Trabeculoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phacoemulsification | Procedure | Lens removal by Phacoemulsification |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Medication-free intraocular pressure control | Proportion of subjects without use of intraocular pressure lowering medications | 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelo Nicolela, MD | Contact | 902-473-2839 | nicolela@dal.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health | Recruiting | Halifax | Nova Scotia | B3H 2Y9 | Canada |
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| ID | Term |
|---|---|
| D017889 | Exfoliation Syndrome |
| ID | Term |
|---|---|
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Selective Laser Trabeculoplasty |
| Device |
Laser application in trabecular meshwork |
|
| 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 |
| D059708 | Ultrasonic Surgical Procedures |