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

Not Applicable

Completed

Conditions: Open Angle Glaucoma

Registration Number: NCT01956942

Lead Sponsor: David Belyea

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure Reduction	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.
Intraocular Pressure (IOP) Reduction Comparison Between MLT and SLT	24-52 week interval	Intraocular pressure (IOP) reduction comparison between MLT and SLT
Intraocular Pressure (IOP) Reduction	52 weeks	Percentage of participants with a decrease of greater or equal to 3 mmHg intraocular pressure from baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1): George Washington University Medical Faculty Associates
🇺🇸
Washington, District of Columbia, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States