Efficacy of Selective Laser Trabeculoplasty Targeting Nasal Versus Inferior 180-degree

NCT06851546 | Completed

• 1 other identifier: 24-008197
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study to optimize Selective Laser Trabeculoplasty (SLT) application when used in the management of open angle glaucoma (OAG)

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Difference in mean intraocular pressure (IOP)

  During each visit, two consecutive IOP measurements will be obtained per eye, and the average of these values will be reported.

  Baseline, 3 months, 6 months, 9 months

Secondary Outcomes (2)

• Change in intraocular pressure (IOP)

  Baseline, 3 months, 6 months, 9 months

• Intraocular pressure (IOP) lowering eye drops

  9 months

Study Arms (2)

Nasal 180° Selective Laser Trabeculoplasty (SLT)

EXPERIMENTAL

The Nasal 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye. After 90 days, the Inferior 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye.

Procedure: Nasal 180° Selective Laser Trabeculoplasty (SLT); Procedure: Inferior 180° Selective Laser Trabeculoplasty (SLT)

Inferior 180° Selective Laser Trabeculoplasty (SLT)

EXPERIMENTAL

The Inferior 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye. After 90 days, the Nasal 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye.

Procedure: Nasal 180° Selective Laser Trabeculoplasty (SLT); Procedure: Inferior 180° Selective Laser Trabeculoplasty (SLT)

Interventions

Nasal 180° Selective Laser Trabeculoplasty (SLT) PROCEDURE

The Nasal 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye. As per standard procedure, the laser will initially be set at 0.8 mJ (or 0.4 mJ for heavily pigmented TM). The energy level will then be adjusted in 0.1 mJ increments: increased until micro-bubble formation is observed or decreased if bubbles are noted. The desired endpoint is the production of a few fine 'champagne bubbles' every 2-3 laser spots. Larger gas bubbles and trabecular meshwork blanching will require the operator to titrate the power downwards in 0.1 mJ increments. Prophylactic IOP lowering and anti-inflammatory drops will be left to physician preference.

Inferior 180° Selective Laser Trabeculoplasty (SLT); Nasal 180° Selective Laser Trabeculoplasty (SLT)

Inferior 180° Selective Laser Trabeculoplasty (SLT) PROCEDURE

The Inferior 180° Selective Laser Trabeculoplasty (SLT) will be performed on the right eye. As per standard procedure, the laser will initially be set at 0.8 mJ (or 0.4 mJ for heavily pigmented TM). The energy level will then be adjusted in 0.1 mJ increments: increased until micro-bubble formation is observed or decreased if bubbles are noted. The desired endpoint is the production of a few fine 'champagne bubbles' every 2-3 laser spots. Larger gas bubbles and trabecular meshwork blanching will require the operator to titrate the power downwards in 0.1 mJ increments. Prophylactic IOP lowering and anti-inflammatory drops will be left to physician preference.

Inferior 180° Selective Laser Trabeculoplasty (SLT); Nasal 180° Selective Laser Trabeculoplasty (SLT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Ability to comprehend the study procedures and agreement to proceed with primary SLT treatment
• Diagnosis of primary or secondary open angle glaucoma or glaucoma suspects with ocular hypertension
• Bilateral disease
• Pre-SLT IOP \>21 mmHg measured at least twice during patient's lifetime with or without medication
• Open angles with moderate to intense trabecular pigmentation
• Mild to moderate visual field defects (24-2 standard mean deviations better than the Swedish interactive thresholding algorithm standard of 12 dB)
• No adequate IOP control (low treatment compliance, substantial adverse effects with eyedrops, and at least 2 IOP measurements higher than the individualized target IOP)

You may not qualify if:

• Unwilling or unable to give consent
• Unable to attend scheduled post-operative visits
• Previous history of either laser treatment or intraocular surgery, except for non-complicated cataract surgery (performed \>6 months before SLT)
• History of ocular trauma
• Narrow angles
• Retinal detachment
• Active iris neovascularization or active proliferative retinopathy
• Active uveitis
• Monocular patients
• Current use of steroids (ocular, periocular, or systemic)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Eye Care Centre, Victoria General Hospital

Halifax, Nova Scotia, NS B3H 2Y9, Canada

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Arthur Sit

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: January 6, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)