The Safety and Efficacy of Direct SLT in Pseudoexfoliatio... | NCT07401290

Studies
The Safety and Efficacy of Direct SLT in Pseudoexfoliation Glaucoma

NCT07401290

Sponsor

Vance Thompson Vision

Status

Not yet recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Pseudoexfoliation Glaucoma

Interventions

Direct selective laser trabeculoplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2026Estimated

Primary Completion Date

Mar 2028Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Feb 3, 2026

First Submission Date that Met QC Criteria

Feb 3, 2026

First Posted Date

Feb 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treated Group	Experimental	Patients treated with DSLT	Device: Direct selective laser trabeculoplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Lorraine Provencher, MD	Contact	402-506-9970		lorraine.provencher@vancethompsonvision.com
Dana Dubas	Contact	402-506-9970		dana.dubas@vancethompsonvision.com

ID	Term
D007499	Iris Diseases
D014603	Uveal Diseases
D005128	Eye Diseases