Recruiting

Superior vs. Temporal Laser

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04741919

Conditions

Primary Angle Glaucoma Closure Suspect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Yag Laser peripheral Iridotomy

Study Details

Brief summary:

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.

Conditions

Primary Angle Glaucoma Closure Suspect

Study ID

NCT04741919

Start date

Nov 25, 2020

Status verified date

Apr, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

\* 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.
  • 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,
  • a history suggestive of an acute angle closure attack (based on symptoms) documented intraocular pressure over 30 mmHg,
  • or any sign of Angle Closure Glaucoma (manifest glaucomatous neuropathy detected by OCT).
  • Patients with previous ocular surgeries will also be excluded.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Superior LPI placement

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

active comparator: Temporal LPI placement

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

Interventions

Yag Laser peripheral Iridotomy

Laser peripheral iridotomy will be performed using neo-dynium:yttrium:aluminium-garnet laser after pretreatment with 2% pilocarpine and brimonidine 0.15%. Superior LPIs will be placed between the 11- and 1-o'clock positions such that they were covered completely by the upper eyelid; nasal/temporal LPIs will be placed between the 2- and 4-o'clock positions or the 8- and 10-o'clock positions such that they were completely clear of the lid margin. Preference will be given to iris crypts, avoiding iris vessels when possible. Laser peripheral iridotomies will be performed in both eyes during the same visit and will be confirmed to be patent after the procedure. Intraoperative data collected will include initial per-shot laser energy in milli joules, number of laser shots, and total laser energy in millijoules. All the patients will be treated with flurometholone 0.1% eye drops QID for 5 days after surgery.

Primary outcome measure

  • Dysphotopsias noted from baseline visit before procedure till 3 months after procedure [ Time Frame: 3 months from baseline visit ]

Central Contacts and Locations

Central contacts

Catherine Birt, MD, FRCSC

416-480-5882catherine.birt@sunnybrook.ca

Cindy Rutz

416-480-5091cindy.rutz@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Catherine Birt, MD, FRCSC

416-480-5882catherine.birt@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 11, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-04-11.