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

NCT ID: NCT06851546

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2025-11-10

Brief Summary

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

Detailed Description

The purpose of this research is to determine the most effective method in using Selective Laser Trabeculoplasty (SLT) for lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. We will investigate the IOP lowering differences between nasal 180° SLT and inferior 180° SLT,. The second stage will assess the effect of repeating SLT in the opposite 180° sector after 3 months.

Conditions

Open Angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nasal 180° Selective Laser Trabeculoplasty (SLT)

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.

Group Type: EXPERIMENTAL

Nasal 180° Selective Laser Trabeculoplasty (SLT)

Intervention Type: 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)

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

Nasal 180° Selective Laser Trabeculoplasty (SLT)

Intervention Type: 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)

Intervention Type: 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.

Interventions

Nasal 180° Selective Laser Trabeculoplasty (SLT)

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.

Intervention Type: PROCEDURE

Inferior 180° Selective Laser Trabeculoplasty (SLT)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Arthur J. Sit, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arthur Sit

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Eye Care Centre, Victoria General Hospital

Halifax, Nova Scotia, Canada

Countries

United States; Canada

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

24-008197

Identifier Type: -

Identifier Source: org_study_id