Open Angle GlaucomaNCT01956942
Micropulse Laser Trabeculoplasty (MLT) Versus Selective Laser Trabeculoplasty (SLT) for Treatment of Open Angle Glaucoma
A study testing Micropulse Laser Trabeculoplasty and Selective Laser Trabeculoplasty in people with Open Angle Glaucoma, run by David Belyea at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Micropulse Laser Trabeculoplasty and Selective Laser Trabeculoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 24 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients of any ange age
- Diagnosis of open angle glaucoma who have not had recent changes in their medication regimen.
Who cannot join
- Patients with active neovascularization of the angle, angle closure glaucoma, angle recession, or anterior uveitis
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Phase IV Study of Micropulse Laser Trabeculoplasty Versus Selective Laser Trabeculoplasty for Treatment of Open Angle Glaucoma
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.
Read the 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.
- Conditions
- Open Angle Glaucoma
- Being tested
- Micropulse Laser Trabeculoplasty, Selective Laser Trabeculoplasty
- Keywords
- GLAUCOMA, MICROPULSE, LASER, TRABECULOPLASTY, OPEN ANGLE, INTRAOCULAR PRESSURE
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse Laser TrabeculoplastyDevice
Also called MLT, Laser
Selective Laser TrabeculoplastyDevice
Also called SLT, Laser
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Selective Laser Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 52 weeks
Secondary outcomes (1)
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
Measured: at the time of treatment and at 1 week following the laser procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2017
- Study completion24 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Belyea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Belyea, George Washington University
- Investigators
- David Belyea, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956942
- Sponsor's protocol ID
- 041310
- Status last verified
- May 2023
- First submitted
- 30 Sep 2013
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18700451Juzych 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.
PubMed 15465546Fea 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.
PubMed 19668712
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Micropulse Laser Trabeculoplasty Versus Selective Laser Trabeculoplasty for Treatment of Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01956942
- Acronym / sponsor ID
- 041310
- Conditions
- Open Angle Glaucoma
- Keywords
- GLAUCOMA, MICROPULSE, LASER, TRABECULOPLASTY, OPEN ANGLE, INTRAOCULAR PRESSURE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- David BelyeaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropulse Laser Trabeculoplasty | Experimental | Device: Micropulse Laser TrabeculoplastyPatient'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. |
| Selective Laser Trabeculoplasty (SLT) | Active comparator | Device: Selective Laser TrabeculoplastyPatient'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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of any ange age
- Diagnosis of open angle glaucoma who have not had recent changes in their medication regimen.
Key exclusion criteria (1 listed)
- Patients with active neovascularization of the angle, angle closure glaucoma, angle recession, or anterior uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micropulse Laser TrabeculoplastyAlso: MLT, Laser | Device | Micropulse Laser Trabeculoplasty |
| Selective Laser TrabeculoplastyAlso: SLT, Laser | Device | Selective Laser Trabeculoplasty (SLT) |
Primary outcome
Intraocular Pressure Reduction
Time frame: 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
Time frame: 24-52 week interval
Intraocular pressure (IOP) reduction comparison between MLT and SLT
Intraocular Pressure (IOP) Reduction
Time frame: 52 weeks
Percentage of participants with a decrease of greater or equal to 3 mmHg intraocular pressure from baseline
1 secondary outcome
Measurement of Pain/Inflammation by a Pain Scale Post Laser Treatments From Micropulse and Selective Laser Trabeculoplasty.
Time frame: at the time of treatment and at 1 week following the laser procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18700451Detry-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.
- Background: PubMed 15465546Juzych 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.
- Background: PubMed 19668712Fea 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Belyea, MD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropulse Laser Trabeculoplasty and Selective Laser Trabeculoplasty in people with Open Angle Glaucoma, run by David Belyea at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure Reduction (time frame: within 6 weeks to 3 months after the laser procedure is completed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01956942, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.