Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT04416724

Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

Led by Nova Scotia Health Authority · Updated on 2024-08-21

200

Participants Needed

1

Research Sites

564 weeks

Total Duration

On this page

Sponsors

N

Nova Scotia Health Authority

Lead Sponsor

G

Glaucoma Research Society of Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of pseudoexfoliation syndrome confirmed by eye exam showing exfoliative material
  • Clinical decision to lower intraocular pressure due to pseudoexfoliation glaucoma or elevated eye pressure
  • Presence of early asymptomatic cataract
  • Age 50 years or older
Not Eligible

You will not qualify if you...

  • Age less than 50 years
  • Narrow anterior chamber angle with less than 180 degrees of visible trabeculum
  • Previous eye pressure lowering procedures such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery
  • Use of intraocular pressure lowering medication for more than 6 months
  • Eye or systemic diseases or medications that affect eye pressure, including uveitis, neovascular or traumatic glaucoma, corneal problems affecting measurement, or oral steroids
  • Baseline eye pressure greater than 36 mmHg
  • Severe visual field damage with mean deviation worse than -15 dB
  • Unable or unwilling to give informed consent to join the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Nova Scotia Health

Halifax, Nova Scotia, Canada, B3H 2Y9

Actively Recruiting

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Research Team

M

Marcelo Nicolela, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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