Trial Outcomes & Findings for Micropulse Laser Trabeculoplasty (MLT) Versus Selective Laser Trabeculoplasty (SLT) for Treatment of Open Angle Glaucoma (NCT NCT01956942)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

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

Results posted on

2023-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Micropulse Laser Trabeculoplasty 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. Micropulse Laser Trabeculoplasty	Selective Laser Trabeculoplasty (SLT) 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. Selective Laser Trabeculoplasty
Overall Study STARTED	38	31
Overall Study COMPLETED	38	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Micropulse Laser Trabeculoplasty n=38 Participants 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. Micropulse Laser Trabeculoplasty	Selective Laser Trabeculoplasty (SLT) n=31 Participants 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. Selective Laser Trabeculoplasty	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=38 Participants	0 Participants n=31 Participants	0 Participants n=69 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=38 Participants	12 Participants n=31 Participants	32 Participants n=69 Participants
Age, Categorical >=65 years	18 Participants n=38 Participants	19 Participants n=31 Participants	37 Participants n=69 Participants
Age, Continuous	66.1 years STANDARD_DEVIATION 0.3 • n=38 Participants	67.6 years STANDARD_DEVIATION .85 • n=31 Participants	66.9 years STANDARD_DEVIATION 0.55 • n=69 Participants
Sex: Female, Male Female	16 Participants n=38 Participants	19 Participants n=31 Participants	35 Participants n=69 Participants
Sex: Female, Male Male	22 Participants n=38 Participants	12 Participants n=31 Participants	34 Participants n=69 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	38 participants n=38 Participants	31 participants n=31 Participants	69 participants n=69 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Micropulse Laser Trabeculoplasty n=38 Participants 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. Micropulse Laser Trabeculoplasty	Selective Laser Trabeculoplasty (SLT) n=31 Participants 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. Selective Laser Trabeculoplasty
Intraocular Pressure Reduction	17.01 percentage change Standard Error 1	14.29 percentage change Standard Error 1

PRIMARY outcome

Timeframe: 24-52 week interval

Population: A total of 69 patients with uncontrolled open-angle glaucoma were recruited, candidates with open-angle glaucoma on maximally tolerated medical therapy with the need for additional IOP lowering. All patients had only one eye included in the study.

Intraocular pressure (IOP) reduction comparison between MLT and SLT

Outcome measures

Outcome measures
Measure	Micropulse Laser Trabeculoplasty n=38 Participants 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. Micropulse Laser Trabeculoplasty	Selective Laser Trabeculoplasty (SLT) n=31 Participants 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. Selective Laser Trabeculoplasty
Intraocular Pressure (IOP) Reduction Comparison Between MLT and SLT	15.7 mmHg Standard Deviation 0.2	14.35 mmHg Standard Deviation 0.3

PRIMARY outcome

Timeframe: 52 weeks

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

Outcome measures

Outcome measures
Measure	Micropulse Laser Trabeculoplasty n=38 Participants 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. Micropulse Laser Trabeculoplasty	Selective Laser Trabeculoplasty (SLT) n=31 Participants 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. Selective Laser Trabeculoplasty
Intraocular Pressure (IOP) Reduction	37 percentage of participants	36 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Micropulse Laser Trabeculoplasty n=38 Participants 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. Micropulse Laser Trabeculoplasty	Selective Laser Trabeculoplasty (SLT) n=31 Participants 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. Selective Laser Trabeculoplasty
Measurement of Pain/Inflammation by a Pain Scale Post Laser Treatments From Micropulse and Selective Laser Trabeculoplasty. During Treatment	1.34 score on a scale Interval 0.0 to 10.0	2.83 score on a scale Interval 0.0 to 10.0
Measurement of Pain/Inflammation by a Pain Scale Post Laser Treatments From Micropulse and Selective Laser Trabeculoplasty. 1 Week Post Treatment	0.89 score on a scale Interval 0.0 to 10.0	2.81 score on a scale Interval 0.0 to 10.0

Adverse Events

Micropulse Laser Trabeculoplasty (MLT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Selective Laser Trabeculoplasty (SLT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Belyea

Ophthalmology Department The George Washington University

Phone: 2027412800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place