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Procedure
Laser Peripheral Iridotomy for Glaucoma
N/A
Recruiting
Led By Catherine Birt, MD, FRCSC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
clinical evidence of bilateral occludable angles (PACS) defined as: Peripheral anterior synechia (PAS) absent and trabecular meshwork not visible in ≥6 clock hours under non-indentation gonioscopy, Along with, absence of PAC or PACG, in both eyes.
Be older than 18 years old
Must not have
or any sign of Angle Closure Glaucoma (manifest glaucomatous neuropathy detected by OCT).
a history suggestive of an acute angle closure attack (based on symptoms) documented intraocular pressure over 30 mmHg,
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months from baseline visit
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the side effects and pain levels of those who have a clear indication for bilateral laser peripheral iridotomy (LPI) in the right or left eye.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include discomfort during the procedure, light flashes, blurry vision right after treatment, minor bleeding inside the eye, and increased eye pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye exam shows I have narrow angles in both eyes but no glaucoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with or show signs of Angle Closure Glaucoma.
Select...
I have had symptoms or an attack of very high eye pressure.
Select...
I have not had any eye surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months from baseline visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months from baseline visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dysphotopsias noted from baseline visit before procedure till 3 months after procedure
Secondary study objectives
Pain during the baseline visit procedure and recollection of pain till 3 months after procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Superior LPI placementActive Control1 Intervention
Each participant will be randomized to receive an LPI placement superiorly in one eye.
Group II: Temporal LPI placementActive Control1 Intervention
Each participant will be randomized to receive an LPI placement temporally in one eye.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,289 Total Patients Enrolled
Catherine Birt, MD, FRCSCPrincipal InvestigatorSunnybrook
1 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye exam shows I have narrow angles in both eyes but no glaucoma.I have been diagnosed with or show signs of Angle Closure Glaucoma.I have had symptoms or an attack of very high eye pressure.I have not had any eye surgeries.
Research Study Groups:
This trial has the following groups:- Group 1: Superior LPI placement
- Group 2: Temporal LPI placement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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