A Prospective Study on the Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in Achieving >20% Intraocular Pressure (IOP) Reduction Without Medications at 6 Months in Naive, Untreated Glaucoma Patients

Conditions

• Glaucoma
• Primary Open Angle Glaucoma
• Primary Open Angle Glaucoma or Ocular Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Direct Selective Laser Trabuloplasty — DEVICE
  Eligible 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

Study Details

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.

Key Dates

Start date

Mar 11, 2002

Status verified

Mar 2025

Primary completion

Feb 1, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

60 participants (estimated)

Arms

• Arm: Primary Open Angle Glaucoma or Ocular Hypertension
  Subjects with primary open angle glaucoma or ocular hypertension with baseline IOPs greater than 21mmHg.

Primary Outcome Measure

Percent Reduction in IOP from baseline at 6 months [ Time Frame: 6 months ]

Central Contacts

• Brian Shafer, MD
  2672102169
  [email protected]

Locations (1)

Find similar trials in Plymouth Meeting, PA

Related Studies

• Novel Glaucoma Diagnostics
  Recruiting · Wills Eye · Philadelphia, Pennsylvania
• Hydrus® Microstent New Enrollment Post-Approval Study
  Recruiting · Alcon Research · Irvine, California
• A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma
  PHASE3 · Recruiting · AbbVie · Glendale, Arizona
• Diagnostic Innovations in Glaucoma Study
  Recruiting · University of California, San Diego · La Jolla, California