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NCT Number: NCT06933836

DSLT Performance in Treatment-naïve Patients With Newly Diagnosed 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.

Recruiting

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Key information

Conditions

Open Angle Glaucoma (OAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnet Dulaney Perkins Eye Centers

Mesa, Arizona, 85206, United States

Location status: Recruiting

Location contact

Christine Funke, Medical Doctor

CONTACT

[email protected]

4804201005

Christine Funke, Medical Doctor

PRINCIPAL_INVESTIGATOR

Derek J Arnson, Master of Education

CONTACT

[email protected]

4804201005

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Other Improvements to Disease State through DSLT Treatment

    Time frame: 12 months

    • Change in mean deviation.. (dB)

  2. Other Improvements to Disease State through DSLT Treatment

    Time frame: 12 months

    • Change in RNFL /GCA (µm)

  3. Other Improvements to Disease State through DSLT Treatment

    Time frame: 12 months

    • Overall IOP reduction (mmHG)

  4. Other Improvements to Disease State through DSLT Treatment

    Time frame: 12 months

    • Medication reduction (#0-5)

  5. Other Improvements to Disease State through DSLT Treatment

    Time frame: 12 months

    • SSIs (% on trabeculectomy, glaucoma drainage implant (GDI), other)

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Funke, Medical Doctor

CONTACT

[email protected]

4804201005

Derek J Arnson, Master of Education

CONTACT

[email protected]

4804201005

Sponsors and collaborators

Lead sponsor

Barnet Dulaney Perkins Eye Centers

Network

Collaborators

  • Alcon, a Novartis Company

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

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.

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