ClinicalTrials.gg
Not yet recruitingNCT07401290Updated Feb 10, 2026

The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma

An interventional study of Direct selective laser trabeculoplasty in Pseudoexfoliation Glaucoma, sponsored by Vance Thompson Vision. Not yet recruiting at 3 sites in United States. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Vance Thompson Vision · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Sex
All
01

Study summary

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

02

Conditions studied

  • Pseudoexfoliation Glaucoma

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03

In context

Exfoliation Syndrome

72 studies on the registry are indexed under Exfoliation Syndrome; 20 are open to participants now.

This study's planned enrollment of 40 is below the median of 64 across 34 interventional studies indexed under Exfoliation Syndrome.

Browse Exfoliation Syndrome studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any 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 (/SLT)
  • History of ocular inflammation and infection
  • Patients who are pregnant or have any systemic disease that may prevent them from reliably completing follow-up visits
  • Vulnerable populations that cannot provide proper will not be enrolled, such as children, prisoners, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Treated Group

    Patients treated with DSLT

    Device: Direct selective laser trabeculoplasty

Interventions

  • DeviceDirect selective laser trabeculoplasty

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

06

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. Secondary Effective Endpoint

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

    Time frame: 12 months

  2. Secondary Effective Endpoint

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

    Time frame: 6 and 12 months

  3. Secondary Effective Endpoint

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

    Time frame: 6 and 12 months

  4. Secondary Effective Endpoint

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

    Time frame: 6 and 12 months

  5. Secondary Effective Endpoint

    Rate of secondary surgical interventions (SSIs) at 12 months

    Time frame: 12 months

  6. 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)

    Time frame: 12 months

07

Study locations

3 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07401290
Lead sponsor
Vance Thompson Vision
Responsible party
Lorraine Provencher (Sponsor-Investigator, Vance Thompson Vision) — Principal investigator
First posted
Feb 10, 2026
Start date
Mar 2026 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Feb 10, 2026

Study contacts

Lorraine Provencher, MD
Contact
lorraine.provencher@vancethompsonvision.com
402-506-9970
Dana Dubas
Contact
dana.dubas@vancethompsonvision.com
402-506-9970

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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