Superior vs Temporal Laser Peripheral Iridotomy in Primary Angle Closure Suspects (PACS)

NCT04741919 | Unknown

• 1 other identifier: 3236_2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Dysphotopsias noted from baseline visit before procedure till 3 months after procedure

  We will inquire if patients experienced any of the following before and/or after the iridotomy: halo, lines, crescent, ghost image, glare, spots, shadows, blurring, or other unlisted visual disturbances. This will be part of the questionnaire completed before the procedure, at 2 weeks, and at 3 months.

  3 months from baseline visit

Secondary Outcomes (1)

• Pain during the baseline visit procedure and recollection of pain till 3 months after procedure

  3 months from baseline visit

Study Arms (2)

Superior LPI placement

ACTIVE COMPARATOR

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

Procedure: Yag Laser peripheral Iridotomy

Temporal LPI placement

ACTIVE COMPARATOR

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

Procedure: Yag Laser peripheral Iridotomy

Interventions

Yag Laser peripheral Iridotomy PROCEDURE

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.

Superior LPI placement; Temporal LPI placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Study Officials

• Catherine Birt, MD, FRCSC

  Sunnybrook

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Birt, MD, FRCSC

CONTACT

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

Cindy Rutz

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant will be randomized to a specific LPI placement (superior or temporal) for one eye, and will be given the other alternative placement for the second eye. This is paired-eye comparative clinical trial.

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: February 5, 2021
• Study Start: November 25, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)