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

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

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:

  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

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.

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

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.

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