Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID04416724

Canadian Pseudoexfoliation Glaucoma Trial: Comparing Phacoemulsification and Selective Laser Trabeculoplasty as Initial Treatments

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

200

Participants Needed

1

Research Sites

417 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

Researchers are evaluating two initial treatment options for patients newly diagnosed with pseudoexfoliation glaucoma who need to lower their intraocular pressure (IOP). This randomized clinical trial compares Selective Laser Trabeculoplasty (SLT), a laser treatment targeting the eye's drainage system, and Phacoemulsification (PHACO), a procedure that removes the lens. The study focuses on patients who also have early, symptom-free lens clouding and aims to determine which treatment better controls IOP without medication over two years. Participants will be randomly assigned to receive either the PHACO procedure or SLT. Those who do not reach their target IOP with the initial treatment will then receive medication to lower IOP. The study follows guidelines from the Canadian Ophthalmological Society for managing glaucoma. Longer-term outcomes will be assessed through chart reviews at five and ten years after treatment. During the study, patients will be monitored regularly for two years to assess their IOP control without medication as the main outcome. Secondary measures include changes in IOP, timing of medication use, visual function reported by patients, and any side effects. The research team will also review records at 5 and 10 years to gather extended follow-up data. Overall participation may last a decade for those involved in long-term monitoring.

CONDITIONS

Brief 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...

  • Pseudoexfoliation syndrome detected by exfoliative material on the eye during slit-lamp exam
  • Clinical decision to lower intraocular pressure based on pseudoexfoliation glaucoma or elevated IOP
  • Presence of early, asymptomatic cataract
Not Eligible

You will not qualify if you...

  • Age less than 50 years
  • Anterior chamber angle closure with less than 180° pigmented trabeculum visible
  • Previous eye pressure lowering procedures such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery
  • Previous use of IOP lowering medication for more than 6 months
  • Eye or systemic conditions or medications affecting IOP, including uveitis, neovascular or traumatic glaucoma, corneal problems, or oral steroids
  • Baseline intraocular pressure higher than 36 mmHg
  • Visual field damage worse than -15 dB mean deviation
  • Unable or unwilling to give informed consent to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure with follow-up as needed

Participants receive either Phacoemulsification (lens removal) or Selective Laser Trabeculoplasty (laser application) as initial treatment for pseudoexfoliation glaucoma.

1 treatment visit plus follow-up visits depending on assigned intervention

Long-term Monitoring

Duration - Up to 10 years

Participants are monitored for medication-free intraocular pressure control and other outcomes up to 10 years after treatment.

Regular visits scheduled over 10 years

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

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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