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NCT Number: NCT01956942

Micropulse Laser Trabeculoplasty (MLT) Versus Selective Laser Trabeculoplasty (SLT) for Treatment of Open Angle Glaucoma

The purpose of this study is to evaluate the effectiveness of a new laser (called Micropulse Laser Trabeculoplasty or MLT) in the treatment of glaucoma compared to the conventional laser presently used which is called selective laser trabeculoplasty or SLT. Both lasers (SLT and MLT) are used as standard of care in the treatment of open angle glaucoma.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

About this study

Glaucoma is the 2nd leading cause of blindness worldwide and affects over 2.5 million Americans over the age of 40. It is thought that elevated intraocular pressure causes damage to the optic nerve fibers which leads to silent vision loss in glaucoma. Therefore, the primary approach to managing this disease process is through intraocular pressure reduction with a) topical drops that decrease intraocular fluid production or increase fluid outflow, b) laser therapy to the outflow structures in the eye (trabecular meshwork) to increase fluid egression, c) or incisional surgery with or without placement of setons to create a new pathway for fluid outflow. When medical therapy has been maximized or patients do not tolerate topical therapy, laser trabeculoplasty is common applied to achieve further intraocular pressure reduction. There are two types of laser therapies: argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). The former involves applying laser to create outflow pathways in the trabecular meshwork (TM) and induces thermal damage to the TM. The latter selectively applies energy which induces inflammatory restructuring of the TM without creating a burn. Studies have shown comparable results between the two treatment modalities with SLT offering the advantage of repeatable treatment. Studies have also shown laser trabeculoplasty to be comparable to the effect of topical drops in intraocular pressure reduction. Side effects for both types of laser trabeculoplasty include post procedure intraocular pressure elevation and intraocular inflammation which is treated with topical drops after the procedure.

This study aims to evaluate the effectiveness of micropulse laser trabeculoplasty in intraocular pressure reduction in patients with open angle glaucoma as compared to conventional selective laser trabeculoplasty. Secondary aims would be to determine whether its reduction is comparable to that of topical intraocular pressure lowering drops, length of therapeutic intraocular pressure reduction, and incidence of side effects commonly encountered with traditional laser trabeculoplasty including intraocular inflammation and intraocular pressure spikes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients of any ange age
  • Diagnosis of open angle glaucoma who have not had recent changes in their medication regimen.

Exclusion criteria

  • Patients with active neovascularization of the angle, angle closure glaucoma, angle recession, or anterior uveitis

Treatment and study plan

Micropulse Laser Trabeculoplasty

Device

Other names: MLT, Laser

Selective laser trabeculoplasty

Device

Other names: SLT, Laser

Primary outcomes

  1. Intraocular Pressure Reduction

    Time frame: within 6 weeks to 3 months after the laser procedure is completed

    evaluate the effectiveness of micropulse laser trabeculoplasty in intraocular pressure reduction in patients with open angle glaucoma as compared to conventional selective laser trabeculoplasty

    The aim of this study was to prospectively compare the efficacy, safety, and tolerability of selective laser trabeculoplasty (SLT) vs micropulse laser trabeculoplasty (MLT) in reducing intraocular pressure (IOP) in open-angle glaucoma patients.

  2. Intraocular Pressure (IOP) Reduction Comparison Between MLT and SLT

    Time frame: 24-52 week interval

    Intraocular pressure (IOP) reduction comparison between MLT and SLT

  3. Intraocular Pressure (IOP) Reduction

    Time frame: 52 weeks

    Percentage of participants with a decrease of greater or equal to 3 mmHg intraocular pressure from baseline

Secondary outcomes

  1. Measurement of Pain/Inflammation by a Pain Scale Post Laser Treatments From Micropulse and Selective Laser Trabeculoplasty.

    Time frame: at the time of treatment and at 1 week following the laser procedure

    The measurement of pain commonly encountered with traditional laser trabeculoplasty including intraocular inflammation will be measured and compared between both lasers (SLT vs. MLT).

    Standardized pain survey (scale of 0=none and 10=severe) Higher number, the more pain was being experienced by subject

Sponsors and collaborators

Lead sponsor

David Belyea

Other

Registry information

Official study title

Phase IV Study of Micropulse Laser Trabeculoplasty Versus Selective Laser Trabeculoplasty for Treatment of Open Angle Glaucoma

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2013
Registry last updated
Jun 13, 2023

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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