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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

NCT07076303 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-07-22

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Direct Selective Laser Trabuloplasty

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

Sponsors & Collaborators

  • Brian Shafer

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-11
Primary Completion
2026-02-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076303 on ClinicalTrials.gov