Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma (CANPEX1)
Primary Purpose
Pseudoexfoliation Glaucoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phacoemulsification
Selective Laser Trabeculoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Pseudoexfoliation Glaucoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phacoemulsification
SLT
Arm Description
Main study intervention will be Phacoemulsification
Main study intervention will be Selective Laser Trabeculoplasty
Outcomes
Primary Outcome Measures
Medication-free intraocular pressure control
Proportion of subjects without use of intraocular pressure lowering medications
Secondary Outcome Measures
Medication-free intraocular pressure control
Proportion of subjects without use of intraocular pressure lowering medications
Intraocular pressure change from baseline
Number of intraocular pressure lowering medications
Time to introduction of intraocular pressure lowering medications
Number of adverse effects
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.
Full Information
NCT ID
NCT04416724
First Posted
June 1, 2020
Last Updated
February 18, 2021
Sponsor
Jayme Vianna
Collaborators
Glaucoma Research Society of Canada, Canadian Glaucoma Society
1. Study Identification
Unique Protocol Identification Number
NCT04416724
Brief Title
Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma
Acronym
CANPEX1
Official Title
Canadian Pseudoexfoliation Glaucoma Trial: Comparison of Phacoemulsification Versus Selective Laser Trabeculoplasty as Initial Treatment for Pseudoexfoliation Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jayme Vianna
Collaborators
Glaucoma Research Society of Canada, Canadian Glaucoma Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudoexfoliation Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phacoemulsification
Arm Type
Experimental
Arm Description
Main study intervention will be Phacoemulsification
Arm Title
SLT
Arm Type
Experimental
Arm Description
Main study intervention will be Selective Laser Trabeculoplasty
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification
Intervention Description
Lens removal by Phacoemulsification
Intervention Type
Device
Intervention Name(s)
Selective Laser Trabeculoplasty
Intervention Description
Laser application in trabecular meshwork
Primary Outcome Measure Information:
Title
Medication-free intraocular pressure control
Description
Proportion of subjects without use of intraocular pressure lowering medications
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Medication-free intraocular pressure control
Description
Proportion of subjects without use of intraocular pressure lowering medications
Time Frame
10 years
Title
Intraocular pressure change from baseline
Time Frame
10 years
Title
Number of intraocular pressure lowering medications
Time Frame
10 years
Title
Time to introduction of intraocular pressure lowering medications
Time Frame
10 years
Title
Number of adverse effects
Time Frame
10 years
Title
Score at the Glaucoma Quality of Life - 15
Description
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.
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayme Vianna, MD
Phone
1-902-473-3765
Email
jayme.vianna@dal.ca
12. IPD Sharing Statement
Learn more about this trial
Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma
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