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

Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956942
• Other study ID #: 041310
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: July 24, 2017

Study information

• Verified date: May 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 24, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Device:
• Micropulse Laser Trabeculoplasty

• Selective Laser Trabeculoplasty

Locations

Country	Name	City	State
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
David Belyea

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Intraocular Pressure (IOP) Reduction Comparison Between MLT and SLT	Intraocular pressure (IOP) reduction comparison between MLT and SLT	24-52 week interval
Primary	Intraocular Pressure (IOP) Reduction	Percentage of participants with a decrease of greater or equal to 3 mmHg intraocular pressure from baseline	52 weeks
Secondary	Measurement of Pain/Inflammation by a Pain Scale Post Laser Treatments From Micropulse and Selective Laser Trabeculoplasty.	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	at the time of treatment and at 1 week following the laser procedure