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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
Jayme Vianna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudoexfoliation Glaucoma

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material on anterior capsule, pupil, or anterior chamber angle
  2. 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
  3. Presence of asymptomatic early cataract

Exclusion Criteria:

  1. Age less than 50 years old
  2. Anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum visible in less than 180º
  3. Previous IOP lowering procedure such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery
  4. Previous use of IOP lowering medication for more than 6 months
  5. 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
  6. IOP at baseline visit higher than 36 mmHg
  7. Visual field damage at baseline visit with mean deviation worse than -15 dB
  8. 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

    First Posted
    June 1, 2020
    Last Updated
    February 18, 2021
    Sponsor
    Jayme Vianna
    Collaborators
    Glaucoma Research Society of Canada, Canadian Glaucoma Society
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    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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