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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment called Yag Laser Peripheral Iridotomy (LPI) for individuals with a specific eye condition known as PACS, which can lead to glaucoma. The study compares two laser application methods to determine which causes fewer light disturbances and less pain over time. Participants should have the condition in both eyes but no history of certain eye problems or surgeries. The trial aims to discover if the laser's position affects the results, with one group receiving treatment on the upper part of the eye and the other on the side. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this laser technique is safe for glaucoma patients?

Research has shown that YAG laser peripheral iridotomy is generally safe for treating certain types of glaucoma. Many patients handle the procedure well, though some experience side effects. One study found that 38% of patients had a temporary rise in eye pressure afterward. About 35% reported seeing particles or glare in their vision, and 19% experienced light bleeding in the iris, the colored part of the eye. Another study identified a few cases of corneal burns, though these were rare. Despite these side effects, the procedure remains widely used and is considered effective for preventing serious eye problems, such as optic nerve damage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Laser Peripheral Iridotomy (LPI) for glaucoma because it offers a targeted approach to relieve eye pressure by creating a small opening in the iris with a laser. Unlike traditional surgical methods, this laser technique is minimally invasive and can be performed in an outpatient setting. The trial compares two different placements of the laser treatment—superior and temporal—to determine the most effective positioning, which could optimize results and improve patient outcomes. This focus on precision and placement could potentially lead to better management of glaucoma, reducing the risk of vision loss with greater convenience for patients.

What evidence suggests that this trial's treatments could be effective for glaucoma?

Research has shown that Yag Laser Peripheral Iridotomy (LPI) effectively treats primary angle-closure glaucoma. Studies have found that LPI can stop sudden glaucoma attacks in most cases. One study discovered that after LPI, 67.2% of patients had a wider angle in their eye, which helps lower eye pressure. However, some patients might notice their vision becomes less clear over time. This trial will compare two different placements of LPI: superior and temporal. While LPI generally works better in Caucasian eyes compared to Asian eyes, it remains a common treatment to prevent serious eye pressure problems. ^{2 6 7 8 9}

Who Is on the Research Team?

Catherine Birt, MD, FRCSC

Principal Investigator

Sunnybrook

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3914230/

Clinical Outcomes of Peripheral Iridotomy in Patients with ... Forty eyes (50.6%) underwent lens extraction due to reduced visual acuity. The mean 10× logMAR visual acuity score for all patients significantly declined from ...

2. esmed.org esmed.org/MRA/mra/article/view/2098

Effects of Laser Peripheral Iridotomy in Primary Angle ... The success rate at 24 weeks ITC more than2 angle was 10.4% , ITC>3angles 22.4% and ITC> 4angles in 67.2% respectively.In all cases, IOP was ...

3. aaojournal.org aaojournal.org/article/S0161-6420(23)00201-4/fulltext

Fourteen-Year Outcome of Angle-Closure Prevention with ... At the 14-year visit, LPI-treated eyes showed more severe nuclear cataract, higher IOP, and larger angle width and limbal anterior chamber depth ...

4. eyewiki.org eyewiki.org/Laser_Peripheral_Iridotomy

Laser Peripheral Iridotomy In AAC, laser iridotomy relieves the attack in most cases. Superior outcomes have been reported in Caucasian eyes compared to Asian eyes. In AAC ...

5. aetna.com aetna.com/cpb/medical/data/300_399/0354.html

YAG Laser in Ophthalmology and Other Selected Indications In a prospective, randomized, controlled trial, Scott et al (2011) tested the hypothesis that Nd:YAG laser peripheral iridotomy (LPI) significantly reduces the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21035866/

YAG laser peripheral iridotomy for the prevention of ... Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were ...

7. glaucoma.org.au glaucoma.org.au/news-details/treatment/what-are-short-and-long-term-effects-of-peripheral-iridotomy-pi-laser

What are Short and Long-Term Effects of Peripheral ... Laser PI helps to reduce the risk of angle closure (sudden rise of intraocular pressure) and reduced risk of glaucoma (optic nerve damage).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07195370

Testing YAG Laser Iridotomy for Primary Angle-Closure ... Study Overview. This study evaluates the effectiveness and safety of YAG laser peripheral iridotomy performed at two different locations ( ...

9. journals.viamedica.pl journals.viamedica.pl/ophthalmology_journal/article/view/OJ.2022.0034/70374

Study of power use and complication frequency of Nd:YAG ... Complications included elevated IOP in 38.27% (31/81), aqueous flare/debris in 34.56% (24/81), iris bleeding in 18.51% (15/81), corneal burns in ...