Background
Glaucoma is a progressive optic neuropathy characterized by elevated intraocular pressure (IOP), leading to irreversible vision loss. Current treatment strategies often involve medications, which can be challenging for patients due to adherence issues and side effects. Direct Selective Laser Trabeculoplasty (DSLT) represents a potential surgical alternative for managing IOP in patients with naive, untreated glaucoma. This study aims to evaluate the efficacy of DSLT in achieving significant IOP reduction without the need for postoperative medications.
Unmet Medical Need:
Overview of DSLT
Direct Selective Laser Trabeculoplasty (DSLT) is an emerging technology in glaucoma management that combines laser techniques to reduce intraocular pressure (IOP). While it works off the auspices of a previous technology (SLT), the method of delivery is significantly different.
Current Research Landscape
Most existing studies focus on patients who have already received other forms of treatment or who have more advanced glaucoma. This creates an unmet need to evaluate how DSLT can be effectively integrated into the management of patients at the very beginning of their glaucoma journey. Understanding its efficacy in this population is crucial for establishing best practices and improving long-term outcomes.
Interventional Glaucoma Management vs. Standard of Care
Standard of care for newly diagnosed glaucoma typically involves medications, such as topical prostaglandin analogs, which can have side effects and may not be effective for all patients. In contrast, interventional glaucoma management-such as DSLT-offers a potentially more direct approach to lowering IOP without the need for ongoing medication. Investigating DSLT in this context could lead to a paradigm shift in how newly diagnosed patients are managed, reducing their reliance on medications and potentially improving adherence and quality of life.
Conclusion
Addressing this research gap will not only help clarify the role of DSLT in early glaucoma management but could also enhance patient outcomes and guide future treatment protocols. Focusing on newly diagnosed patients is essential for determining the long-term benefits and risks associated with this innovative technology.
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Subjects 18 years or older who have primary open angle glaucoma or ocular hypertension who are treatment naïve.
Cohort
Prospective
Direct Selective Laser Trabuloplasty
DeviceEligible participants will undergo the DSLT procedure to facilitate controlled aqueous outflow. DSLT will consist of 120 shots, 400 µm spot size, energy 1.4-1.8 mJ delivered at the limbus over 2.4 seconds
Percent Reduction in IOP from baseline at 6 months
Percent Reduction in IOP from baseline at 6 months
Percentage of Eyes Achieving ≥ 20% Reduction in IOP at 6 months
The success rate of IOP reduction at 6 months, where success is defined as % of eyes achieving ≥20% reduction from baseline pre-treatment IOP.
IOP reduction from baseline at 1 and 3 months
Percentage IOP reduction from baseline at 1 and 3 months
Rate of Secondary Interventions at 6 months
The rate of secondary interventions (e.g., additional treatment or procedures) at 6 months post-DSLT.
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Brian Shafer
Lead sponsor
Shafer Vision Institute
Sponsor institution
