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

NCT01956942 | Completed Results

• 1 other identifier: 041310
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma

Keywords

GLAUCOMA; MICROPULSE; LASER; TRABECULOPLASTY; OPEN ANGLE; INTRAOCULAR PRESSURE

Outcome Measures

Primary Outcomes (3)

• Intraocular Pressure Reduction

  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.

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

• Intraocular Pressure (IOP) Reduction Comparison Between MLT and SLT

  Intraocular pressure (IOP) reduction comparison between MLT and SLT

  24-52 week interval

• Intraocular Pressure (IOP) Reduction

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

  52 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Micropulse Laser Trabeculoplasty

EXPERIMENTAL

Patient's randomized to MLT would be treated with the following settings: 300 micron spot size, 0.3 second duration, 15% duty cycle, and 1000 milliWatt power. They would be treated with confluent laser spots across the entire 360 degrees of the trabecular meshwork. Each patient would receive pre-treatment with a drop on iopidine or brimonidine to prevent post-operative intraocular pressure (IOP) spikes as per standard pre-laser trabeculoplasty protocol.

Device: Micropulse Laser Trabeculoplasty

Selective Laser Trabeculoplasty (SLT)

ACTIVE COMPARATOR

Patient's randomized to SLT would be treated with the following settings: 400 micron spot size, 0.3 second duration, and 1.00 milliWatt (mW) power. They would be treated with confluent laser spots across the entire 360 degrees of the trabecular meshwork. Each patient would receive pre-treatment with a drop on iopidine or brimonidine to prevent post-operative IOP spikes as per standard pre-laser trabeculoplasty protocol.

Device: Selective Laser Trabeculoplasty

Interventions

Micropulse Laser Trabeculoplasty DEVICE

Also known as: MLT, Laser

Micropulse Laser Trabeculoplasty

Selective Laser Trabeculoplasty DEVICE

Also known as: SLT, Laser

Selective Laser Trabeculoplasty (SLT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• David Belyea: lead

Study Sites (1)

George Washington University Medical Faculty Associates

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

Location

Related Publications (3)

• Detry-Morel M, Muschart F, Pourjavan S. Micropulse diode laser (810 nm) versus argon laser trabeculoplasty in the treatment of open-angle glaucoma: comparative short-term safety and efficacy profile. Bull Soc Belge Ophtalmol. 2008;(308):21-8.

  PMID: 18700451 BACKGROUND

• Juzych MS, Chopra V, Banitt MR, Hughes BA, Kim C, Goulas MT, Shin DH. Comparison of long-term outcomes of selective laser trabeculoplasty versus argon laser trabeculoplasty in open-angle glaucoma. Ophthalmology. 2004 Oct;111(10):1853-9. doi: 10.1016/j.ophtha.2004.04.030.

  PMID: 15465546 BACKGROUND

• Fea AM, Bosone A, Rolle T, Brogliatti B, Grignolo FM. Micropulse diode laser trabeculoplasty (MDLT): A phase II clinical study with 12 months follow-up. Clin Ophthalmol. 2008 Jun;2(2):247-52. doi: 10.2147/opth.s2303.

  PMID: 19668712 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Lasers

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Limitations and Caveats

One site.

Results Point of Contact

• Title: Dr. David Belyea
• Organization: Ophthalmology Department The George Washington University

dbelyea@mfa.gwu.edu

2027412800

Study Officials

• David Belyea, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 24, 2017
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-05

Locations

US (1)