The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma

NCT07401290 | Not Yet Recruiting FDA Device

• 1 other identifier: DSLT_PXFG IIT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pseudoexfoliation Glaucoma

Outcome Measures

Primary Outcomes (1)

• Primary Effective Endpoint

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

  6 months

Secondary Outcomes (6)

• Secondary Effective Endpoint

  12 months

• Secondary Effective Endpoint

  6 and 12 months

• Secondary Effective Endpoint

  6 and 12 months

• Secondary Effective Endpoint

  6 and 12 months

• Secondary Effective Endpoint

  12 months

Study Arms (1)

Treated Group

EXPERIMENTAL

Patients treated with DSLT

Device: Direct selective laser trabeculoplasty

Interventions

Direct selective laser trabeculoplasty DEVICE

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

Treated Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (3)

Vance Thompson Vision

Alexandria, Minnesota, 56308, United States

Location

Vance Thompson Vision

Omaha, Nebraska, 68137, United States

Location

Vance Thompson Vision

Fargo, North Dakota, 58078, United States

Location

MeSH Terms

Conditions

Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases

Central Study Contacts

Lorraine Provencher, MD

CONTACT

402-506-9970; lorraine.provencher@vancethompsonvision.com

Dana Dubas

CONTACT

402-506-9970; dana.dubas@vancethompsonvision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (3)