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NCT Number: NCT07401290

The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma

Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vance Thompson Vision, Alexandria, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients diagnosed with pseudoexfoliation glaucoma (PXFG), with optic neuropathy consistent with glaucomatous damage of any severity
  • Open iridocorneal angle by gonioscopy, defined as a Shafer Grade II or greater
  • Treatment naive, or washed out IOP ranging from ≥18-35 mmHg
  • Able to complete medication washout safely and all follow-up visits
  • Participants must have a best correct visual acuity of 20/40 or better in the study eye(s), be able to undertake a reliable Humphrey visual field (HVF) (defined as fixation losses, false positives and false negatives less than 33%), and must have field loss no worse than -20 dB in treatment eye

Exclusion criteria

  • Any contraindication to SLT or unable to have DSLT
  • Angle closure glaucoma or any other types of glaucoma other than PXFG
  • Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye
  • Any prior refractive surgery
  • H/o LPI within last 6 months
  • A history of any significant cataract required during study duration or cataract surgery in the last 6 months
  • Prior laser trabeculoplasty (ALT/SLT)
  • History of ocular inflammation and infection
  • Patients who are pregnant or have any clinically relevant systemic disease that may prevent them from reliably completing follow-up visits
  • Vulnerable populations that cannot provide proper informed consent will not be enrolled, such as children, prisoners, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons

Treatment and study plan

Direct selective laser trabeculoplasty

Device

A non-invasive laser procedure for treating glaucoma and ocular hypertension by improving the eye's natural fluid drainage

Primary outcomes

  1. Primary Effective Endpoint

    Time frame: 6 months

    Proportion of eyes achieving ≥20% reduction in washed-out IOP at month 6 compared to washed-out baseline IOP

Secondary outcomes

  1. Secondary Effective Endpoint

    Time frame: 12 months

    Proportion of eyes achieving ≥ 20% reduction in washed out IOP at month 12 compared to washed-out baseline IOP

  2. Secondary Effective Endpoint

    Time frame: 6 and 12 months

    Mean washed out IOP reduction at 6 and 12 months as compared to washed-out baseline IOP

  3. Secondary Effective Endpoint

    Time frame: 6 and 12 months

    Change in # of glaucoma medication(s) at 6 and 12 months

  4. Secondary Effective Endpoint

    Time frame: 6 and 12 months

    Proportion of medication free eyes post-DSLT at 6 and 12 months

  5. Secondary Effective Endpoint

    Time frame: 12 months

    Rate of secondary surgical interventions (SSIs) at 12 months

  6. Secondary Effective Endpoint

    Time frame: 12 months

    Kaplan-Meier survival analysis at 12 months: time to failure (failure defined as an increase in glaucoma medications from baseline or additional IOP lowering procedure)

Study contacts

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

Dana Dubas

CONTACT

[email protected]

402-506-9970

Lorraine Provencher, MD

CONTACT

[email protected]

402-506-9970

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

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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