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Completed

NCT Number: NCT06851546

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

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

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Care Centre, Victoria General Hospital, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

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.

Primary outcomes

  1. Difference in mean intraocular pressure (IOP)

    Time frame: 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 outcomes

  1. Change in intraocular pressure (IOP)

    Time frame: Baseline, 3 months, 6 months, 9 months

    Change in intraocular pressure (IOP), reported as a percentage

  2. Intraocular pressure (IOP) lowering eye drops

    Time frame: 9 months

    Total number of patients that did not need intraocular pressure (IOP) lowering drops after the selective laser trabeculoplasty (SLT)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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