Laser Peripheral Iridotomy for Glaucoma

Overseen By Cindy Rutz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Unilateral PACS, Acute angle closure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Basic Study Design: Prospective, randomized, single-center, single-blinded study to compare dysphotopsias and pain recollection immediately 2 weeks, and 3 months after LPI in PACS patients who have a clear indication for bilateral LPI. Our null hypothesis is that there is no difference in dysphotopsia or pain levels by LPI position. Our alternate hypothesis is that there are more dysphotopsias superiorly and more pain temporally.

Research Team

Catherine Birt, MD, FRCSC

Principal Investigator

Sunnybrook

Eligibility Criteria

This trial is for people with a condition where the eye's drainage angle is too narrow, risking glaucoma. They must have normal macular and optic nerve scans and no history of severe eye pressure or past surgeries. Both eyes should be at risk but not yet have full-blown glaucoma.

Inclusion Criteria

My eye exam shows I have narrow angles in both eyes but no glaucoma.

macular and optic nerve OCT within the 95% range of the normative database for patients to be included in this study.

Exclusion Criteria

evidence of unilateral PACS,

I have been diagnosed with or show signs of Angle Closure Glaucoma.

I have had symptoms or an attack of very high eye pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo laser peripheral iridotomy (LPI) in both eyes, with one eye receiving superior LPI and the other temporal LPI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for dysphotopsias and pain recollection at 2 weeks and 3 months after LPI

3 months

2 visits (in-person)

Treatment Details

Interventions

• Yag Laser peripheral Iridotomy

Trial Overview The study tests if there's a difference in visual disturbances or pain when making a small hole (LPI) with a laser in different parts of the iris to prevent glaucoma. Patients are randomly chosen to get LPI either above or on the side of their iris.

Participant Groups

Group I: Superior LPI placement Active Control 1 Intervention

Each participant will be randomized to receive an LPI placement superiorly in one eye.

Group II: Temporal LPI placement Active Control 1 Intervention

Each participant will be randomized to receive an LPI placement temporally in one eye.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+