NCT04416724

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
88mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Oct 2022Aug 2033

First Submitted

Initial submission to the registry

June 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
2.4 years until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2033

Expected
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

June 1, 2020

Last Update Submit

August 19, 2024

Conditions

Pseudoexfoliation Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Medication-free intraocular pressure control

    Proportion of subjects without use of intraocular pressure lowering medications

    2 years

Secondary Outcomes (6)

  • Medication-free intraocular pressure control

    10 years

  • Intraocular pressure change from baseline

    10 years

  • Number of intraocular pressure lowering medications

    10 years

  • Time to introduction of intraocular pressure lowering medications

    10 years

  • Number of adverse effects

    10 years

  • +1 more secondary outcomes

Study Arms (2)

Phacoemulsification

EXPERIMENTAL

Main study intervention will be Phacoemulsification

Procedure: Phacoemulsification

SLT

EXPERIMENTAL

Main study intervention will be Selective Laser Trabeculoplasty

Device: Selective Laser Trabeculoplasty

Interventions

PhacoemulsificationPROCEDURE

Lens removal by Phacoemulsification

Phacoemulsification
Selective Laser TrabeculoplastyDEVICE

Laser application in trabecular meshwork

SLT

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

MeSH Terms

Conditions

Exfoliation Syndrome

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Iris DiseasesUveal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Central Study Contacts

Marcelo Nicolela, MD

CONTACT

902-473-2839nicolela@dal.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 4, 2020

Study Start

October 10, 2022

Primary Completion

August 1, 2025

Study Completion (Estimated)

August 1, 2033

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations

CA(1)