DSLT Performance in Treatment-naïve Patients With Newly Diagnosed Open Angle Glaucoma

April 16, 2025 updated by: Barnet Dulaney Perkins Eye Centers

How Does First Line Treatment With DSLT Perform in Treatment-naïve Patients With Newly Diagnosed Primary Open Angle Glaucoma

DSLT demonstrates a ≥ 20% reduction of IOP from pre-treatment baseline in POAG patients naïve of previous glaucoma treatment at 12 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

DSLT enables newly diagnosed patients to remain well controlled and off medications

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Barnet Dulaney Perkins Eye Centers
        • Contact:
        • Contact:
        • Contact:
          • Christine Funke, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

55 Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POAG subjects

Description

Inclusion Criteria:

  • Primary open angle glaucoma
  • Patients age 30 or greater with an IOP of 18-26 mmHg
  • Mild to moderate POAG patients (mild or moderate according to the AAO PPP Guidelines)
  • DSLT procedure

Exclusion Criteria:

  • History of prior glaucoma treatment - this includes past medication use (in either eye), previous lasers or incisional surgery
  • Angle closure patients
  • Ocular Hypertension
  • Baseline VF MD of worse than -12dB
  • Uncontrolled systemic microvascular disease (eg. HTN, DM)
  • Subjects with peri-limbal findings (e.g. melanosis, tumors, extensive pterygium, significant senile arcus and pterygium)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment naïve (including medication in either eye, previous laser or surgery) mild to moderate POA
(including medication in either eye, previous laser or surgery) mild to moderate POA
Device: DSLT enables newly diagnosed patients to remain well controlled and off medications
DSLT enables newly diagnosed patients to remain well controlled and off medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of IOP Reduction Through DSLT Utilization
Time Frame: 12 months
Proportion of patients (%) with DSLT success as defined as IOP lowering of >20% and no additional medications or procedures at 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other Improvements to Disease State through DSLT Treatment
Time Frame: 12 months
• Change in mean deviation.. (dB)
12 months
Other Improvements to Disease State through DSLT Treatment
Time Frame: 12 months
• Change in RNFL /GCA (µm)
12 months
Other Improvements to Disease State through DSLT Treatment
Time Frame: 12 months
• Overall IOP reduction (mmHG)
12 months
Other Improvements to Disease State through DSLT Treatment
Time Frame: 12 months
• Medication reduction (#0-5)
12 months
Other Improvements to Disease State through DSLT Treatment
Time Frame: 12 months
• SSIs (% on trabeculectomy, glaucoma drainage implant (GDI), other)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barnet Dulaney Perkins Eye Centers

Collaborators

Alcon, a Novartis Company

Investigators

  • Principal Investigator: Christine Funke, Medical Doctor, Barnet Dulaney Perkins Eye Centers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alcon - IIT Proposal 95645649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon completion of the study collection, the investigators will share the findings of the DSLT treatment with other researchers to then be published

IPD Sharing Time Frame

The data will be available after the study is completed tentatively 12/2026 and available for 12 months until 12/2027.

IPD Sharing Access Criteria

The investigators will allow other researchers to contact us for information and the study results, the final results is the only thing that others will have access to upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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