Pseudoexfoliation GlaucomaNCT07401290
The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma
A study testing Direct selective laser trabeculoplasty in people with Pseudoexfoliation Glaucoma, run by Vance Thompson Vision at 3 sites in United States.
Trial summary
Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pseudoexfoliation Glaucoma
- What is being tested?
- Direct selective laser trabeculoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Vance Thompson Vision
Alexandria, Minnesota, 56308
Deborah Ristvedt, DO, (320) 762-2166, deborah.ristvedt@vancethompsonvision.com
Miranda Danielson, (320) 762-2166, miranda.danielson@vancethompsonvision.com
Vance Thompson Vision
Fargo, North Dakota, 58078
Michael Greenwood, MD, (701) 566-5390, michael.greenwood@vancethompsonvision.com
McKenzie Schueller, (701) 566-5390, mckenzie.schueller@vancethompsonvision.com
Vance Thompson Vision
Omaha, Nebraska, 68137
Lorraine Provencher, MD, 4025069970, lorraine.provencher@vancethompsonvision.com
Dana Dubas, 4025069970
About this study
Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma.
- Conditions
- Pseudoexfoliation Glaucoma
- Being tested
- Direct selective laser trabeculoplasty
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct selective laser trabeculoplastyDevice
A non-invasive laser procedure for treating glaucoma and ocular hypertension by improving the eye's natural fluid drainage
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Experimental | Patients treated with DSLT Receives: Device: Direct selective laser trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effective Endpoint
Proportion of eyes achieving ≥20% reduction in washed-out IOP at month 6 compared to washed-out baseline IOP
Measured: 6 months
Secondary outcomes (6)
Secondary Effective Endpoint
Proportion of eyes achieving ≥ 20% reduction in washed out IOP at month 12 compared to washed-out baseline IOP
Measured: 12 months
Secondary Effective Endpoint
Mean washed out IOP reduction at 6 and 12 months as compared to washed-out baseline IOP
Measured: 6 and 12 months
Secondary Effective Endpoint
Change in # of glaucoma medication(s) at 6 and 12 months
Measured: 6 and 12 months
Secondary Effective Endpoint
Proportion of medication free eyes post-DSLT at 6 and 12 months
Measured: 6 and 12 months
Secondary Effective Endpoint
Rate of secondary surgical interventions (SSIs) at 12 months
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoexfoliation GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorraine Provencher, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401290
- Sponsor's protocol ID
- DSLT_PXFG IIT
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma
- ClinicalTrials.gov ID
- NCT07401290
- Acronym / sponsor ID
- DSLT_PXFG IIT
- Conditions
- Pseudoexfoliation Glaucoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, single arm, interventional study evaluating DSLT in patients with pseudoexfoliative glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Experimental | Device: Direct selective laser trabeculoplastyPatients treated with DSLT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct selective laser trabeculoplastyA non-invasive laser procedure for treating glaucoma and ocular hypertension by improving the eye's natural fluid drainage | Device | Treated Group |
Primary outcome
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
6 secondary outcomes
Secondary Effective Endpoint
Time frame: 12 months
Secondary Effective Endpoint
Time frame: 6 and 12 months
Secondary Effective Endpoint
Time frame: 6 and 12 months
Secondary Effective Endpoint
Time frame: 6 and 12 months
Secondary Effective Endpoint
Time frame: 12 months
Secondary Effective Endpoint
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct selective laser trabeculoplasty in people with Pseudoexfoliation Glaucoma, run by Vance Thompson Vision at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorraine Provencher, MD (402-506-9970, lorraine.provencher@vancethompsonvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effective Endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.