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

Primary Purpose

Open Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micropulse Laser Trabeculoplasty
Selective Laser Trabeculoplasty
Sponsored by
David Belyea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring GLAUCOMA, MICROPULSE, LASER, TRABECULOPLASTY, OPEN ANGLE, INTRAOCULAR PRESSURE

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • George Washington University Medical Faculty Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Micropulse Laser Trabeculoplasty

Selective Laser Trabeculoplasty (SLT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Intraocular Pressure (IOP) Reduction Comparison Between MLT and SLT
Intraocular pressure (IOP) reduction comparison between MLT and SLT
Intraocular Pressure (IOP) Reduction
Percentage of participants with a decrease of greater or equal to 3 mmHg intraocular pressure from baseline

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2013
Last Updated
May 19, 2023
Sponsor
David Belyea
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1. Study Identification

Unique Protocol Identification Number
NCT01956942
Brief Title
Micropulse Laser Trabeculoplasty (MLT) Versus Selective Laser Trabeculoplasty (SLT) for Treatment of Open Angle Glaucoma
Official Title
Phase IV Study of Micropulse Laser Trabeculoplasty Versus Selective Laser Trabeculoplasty for Treatment of Open Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Belyea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
GLAUCOMA, MICROPULSE, LASER, TRABECULOPLASTY, OPEN ANGLE, INTRAOCULAR PRESSURE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micropulse Laser Trabeculoplasty
Arm Type
Experimental
Arm Description
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.
Arm Title
Selective Laser Trabeculoplasty (SLT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Micropulse Laser Trabeculoplasty
Other Intervention Name(s)
MLT, Laser
Intervention Type
Device
Intervention Name(s)
Selective Laser Trabeculoplasty
Other Intervention Name(s)
SLT, Laser
Primary Outcome Measure Information:
Title
Intraocular Pressure Reduction
Description
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.
Time Frame
within 6 weeks to 3 months after the laser procedure is completed
Title
Intraocular Pressure (IOP) Reduction Comparison Between MLT and SLT
Description
Intraocular pressure (IOP) reduction comparison between MLT and SLT
Time Frame
24-52 week interval
Title
Intraocular Pressure (IOP) Reduction
Description
Percentage of participants with a decrease of greater or equal to 3 mmHg intraocular pressure from baseline
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Measurement of Pain/Inflammation by a Pain Scale Post Laser Treatments From Micropulse and Selective Laser Trabeculoplasty.
Description
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
Time Frame
at the time of treatment and at 1 week following the laser procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Belyea, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18700451
Citation
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.
Results Reference
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PubMed Identifier
15465546
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.
Results Reference
background
PubMed Identifier
19668712
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.
Results Reference
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Micropulse Laser Trabeculoplasty (MLT) Versus Selective Laser Trabeculoplasty (SLT) for Treatment of Open Angle Glaucoma

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