The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pseudoexfoliation Glaucoma
• Intervention / Treatment: Device: Direct selective laser trabeculoplasty

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorraine Provencher, MD; Phone Number: 402-506-9970; Email: lorraine.provencher@vancethompsonvision.com
• Study Contact Backup: Name: Dana Dubas; Phone Number: 402-506-9970; Email: dana.dubas@vancethompsonvision.com

Study Locations

• United States
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Vance Thompson Vision
      • Contact: Deborah Ristvedt, DO; Phone Number: (320) 762-2166; Email: deborah.ristvedt@vancethompsonvision.com
      • Contact: Miranda Danielson; Phone Number: (320) 762-2166; Email: miranda.danielson@vancethompsonvision.com
  • Nebraska
    • Omaha, Nebraska, United States, 68137
      • Vance Thompson Vision
      • Contact: Lorraine Provencher, MD; Phone Number: 4025069970; Email: lorraine.provencher@vancethompsonvision.com
      • Contact: Dana Dubas; Phone Number: 4025069970
  • North Dakota
    • Fargo, North Dakota, United States, 58078
      • Vance Thompson Vision
      • Contact: Michael Greenwood, MD; Phone Number: (701) 566-5390; Email: michael.greenwood@vancethompsonvision.com
      • Contact: McKenzie Schueller; Phone Number: (701) 566-5390; Email: mckenzie.schueller@vancethompsonvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated Group; Patients treated with DSLT	Device: Direct selective laser trabeculoplasty; A non-invasive laser procedure for treating glaucoma and ocular hypertension by improving the eye's natural fluid drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effective Endpoint	Proportion of eyes achieving ≥ 20% reduction in washed out IOP at month 12 compared to washed-out baseline IOP	12 months
Secondary Effective Endpoint	Mean washed out IOP reduction at 6 and 12 months as compared to washed-out baseline IOP	6 and 12 months
Secondary Effective Endpoint	Change in # of glaucoma medication(s) at 6 and 12 months	6 and 12 months
Secondary Effective Endpoint	Proportion of medication free eyes post-DSLT at 6 and 12 months	6 and 12 months
Secondary Effective Endpoint	Rate of secondary surgical interventions (SSIs) at 12 months	12 months
Secondary Effective Endpoint	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)	12 months

Collaborators and Investigators

• Sponsor: Vance Thompson Vision

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Iris Diseases; Exfoliation Syndrome
• Other Study ID Numbers: DSLT_PXFG IIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes