George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
NCT Number: NCT01956942
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Washington D.C., District of Columbia, 20037, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: MLT, Laser
Other names: SLT, Laser
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.
Time frame: 24-52 week interval
Intraocular pressure (IOP) reduction comparison between MLT and SLT
Time frame: 52 weeks
Percentage of participants with a decrease of greater or equal to 3 mmHg intraocular pressure from baseline
Time frame: 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
David Belyea
Other
Phase IV Study of Micropulse Laser Trabeculoplasty Versus Selective Laser Trabeculoplasty for Treatment of Open Angle Glaucoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07082816
Eye Diseases, Glaucoma
Dothan, Alabama, United States
View Trial DetailsNCT06441643
Eye Diseases, Glaucoma
Garden Grove, California, United States
View Trial DetailsNCT05938699
Eye Diseases, Glaucoma
Rochester, Minnesota, United States
View Trial DetailsNCT04773106
Eye Diseases, Glaucoma
Bochum, Germany
View Trial Details