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

Not Applicable

Recruiting

• Conditions: Open Angle Glaucoma

• Registration Number: NCT06851546
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2025-01-06
• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-17
• Study Completion: 2025-12-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Difference in mean intraocular pressure (IOP)	Baseline, 3 months, 6 months, 9 months	During each visit, two consecutive IOP measurements will be obtained per eye, and the average of these values will be reported.

Secondary Outcome Measures

Name	Time	Method
Change in intraocular pressure (IOP)	Baseline, 3 months, 6 months, 9 months	Change in intraocular pressure (IOP), reported as a percentage
Intraocular pressure (IOP) lowering eye drops	9 months	Total number of patients that did not need intraocular pressure (IOP) lowering drops after the selective laser trabeculoplasty (SLT)

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Eye Care Centre, Victoria General Hospital; 🇨🇦 Halifax, Nova Scotia, Canada