Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

NCT ID: NCT04416724

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2033-08-31

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.

Conditions

Pseudoexfoliation Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phacoemulsification

Main study intervention will be Phacoemulsification

Group Type: EXPERIMENTAL

Phacoemulsification

Intervention Type: PROCEDURE

Lens removal by Phacoemulsification

SLT

Main study intervention will be Selective Laser Trabeculoplasty

Group Type: EXPERIMENTAL

Selective Laser Trabeculoplasty

Intervention Type: DEVICE

Laser application in trabecular meshwork

Interventions

Phacoemulsification

Lens removal by Phacoemulsification

Intervention Type: PROCEDURE

Selective Laser Trabeculoplasty

Laser application in trabecular meshwork

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaucoma Research Society of Canada

OTHER

Sponsor Role: collaborator

Canadian Glaucoma Society

UNKNOWN

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nova Scotia Health

Halifax, Nova Scotia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marcelo Nicolela, MD

Role: CONTACT

nicolela@dal.ca

902-473-2839

Facility Contacts

Marcelo Nicolela, MD

Role: primary

nicolela@dal.ca

902-473-2839

Other Identifiers

CANPEX1

Identifier Type: -

Identifier Source: org_study_id