- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04416724
Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma (CANPEX1)
February 18, 2021 updated by: Jayme Vianna
Canadian Pseudoexfoliation Glaucoma Trial: Comparison of Phacoemulsification Versus Selective Laser Trabeculoplasty as Initial Treatment for Pseudoexfoliation Glaucoma
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jayme Vianna, MD
- Phone Number: 1-902-473-3765
- Email: jayme.vianna@dal.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Phacoemulsification
Main study intervention will be Phacoemulsification
|
Lens removal by Phacoemulsification
|
EXPERIMENTAL: SLT
Main study intervention will be Selective Laser Trabeculoplasty
|
Laser application in trabecular meshwork
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication-free intraocular pressure control
Time Frame: 2 years
|
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
Time Frame: 10 years
|
Proportion of subjects without use of intraocular pressure lowering medications
|
10 years
|
Intraocular pressure change from baseline
Time Frame: 10 years
|
10 years
|
|
Number of intraocular pressure lowering medications
Time Frame: 10 years
|
10 years
|
|
Time to introduction of intraocular pressure lowering medications
Time Frame: 10 years
|
10 years
|
|
Number of adverse effects
Time Frame: 10 years
|
10 years
|
|
Score at the Glaucoma Quality of Life - 15
Time Frame: 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.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 1, 2021
Primary Completion (ANTICIPATED)
August 1, 2023
Study Completion (ANTICIPATED)
August 1, 2033
Study Registration Dates
First Submitted
June 1, 2020
First Submitted That Met QC Criteria
June 3, 2020
First Posted (ACTUAL)
June 4, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 21, 2021
Last Update Submitted That Met QC Criteria
February 18, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CANPEX1
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pseudoexfoliation Glaucoma
-
Peeter KudduEnrolling by invitationCataract | Pseudoexfoliation Glaucoma | Pseudoexfoliation Syndrome | PseudoexfoliationFinland
-
Assiut UniversityCompletedPseudoexfoliation Syndrome | Pseudoexfoliation Glaucoma in Both Eyes | Pseudoexfoliation of Lens; GlaucomaEgypt
-
Wills EyeTanta Medical School, Tanta UniversityWithdrawnPrimary Open Angle Glaucoma | Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliation Glaucoma in Both EyesUnited States
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Vastra Gotaland RegionGöteborg UniversityActive, not recruitingOcular Hypertension | Glaucoma, Open-Angle | Pseudoexfoliation GlaucomaSweden
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Medical University InnsbruckNot yet recruitingPrimary Open Angle Glaucoma | Pseudoexfoliation GlaucomaAustria
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Vastra Gotaland RegionGöteborg UniversityEnrolling by invitationPrimary Open Angle Glaucoma | Pseudoexfoliation GlaucomaSweden
-
Queen's UniversityPfizer; Glaucoma Research Society of CanadaCompletedPrimary Open Angle Glaucoma | Pseudoexfoliation GlaucomaCanada
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Vastra Gotaland RegionGöteborg UniversityEnrolling by invitationOcular Hypertension | Glaucoma, Open-Angle | Pseudoexfoliation GlaucomaSweden
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[Redacted]WithheldPrimary Open Angle Glaucoma | Open Angle Glaucoma | Pseudoexfoliation Glaucoma | Pigmentary GlaucomaUnited States, Germany, Italy, Philippines, Spain, United Kingdom
-
University Hospital of PatrasCompletedMicropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation GlaucomaPrimary Open-angle Glaucoma | Pseudoexfoliation Glaucoma
Clinical Trials on Phacoemulsification
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University Tunis El ManarCompletedEffect of Cataract Surgery on Corneal Endothelium; About 2 TechniquesTunisia
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State University of New York at BuffaloActive, not recruitingGlaucomaUnited States
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University of California, San FranciscoTerminated
-
Iladevi Cataract and IOL Research CenterCompleted
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University of Turin, ItalyCompleted
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Centre Hospitalier Régional Metz-ThionvilleCompleted
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Democritus University of ThraceCompleted
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Ophthalmic Consultants, Corneal and Refractive...Unknown
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Iladevi Cataract and IOL Research CenterCompletedPosterior Capsule OpacificationIndia