Change in IOP Fluctuation After DSLT

NCT07428668 | Recruiting FDA Device

• 1 other identifier: BF-26-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, single-arm, observational study designed to evaluate the change in diurnal intraocular pressure (IOP) fluctuation following Direct Selective Laser Trabeculoplasty (DSLT) in patients with primary open-angle glaucoma (POAG) who are on 1-3 IOP lowering medications. The study will be conducted at one site and will involve three key visits: a screening visit, a baseline/treatment visit, and a 6-month follow-up visit. During the screening visit, patients will undergo a comprehensive ophthalmic examination, and eligibility will be confirmed. The eye with the higher IOP will be selected if both eyes are eligible. At the baseline visit, diurnal IOP will be recorded at three time points (9am, 12pm, and 4pm) before DSLT is performed. The primary endpoint is the change in diurnal IOP fluctuation 6 months post-treatment. Secondary endpoints include changes in mean diurnal IOP and the proportion of eyes achieving a reduction in IOP fluctuations of ≥1 mmHg. Exploratory endpoints focus on demographic variables associated with IOP fluctuation changes.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Change in diurnal intraocular pressure (IOP) fluctuation

  Measured at baseline and at 6 months post-DSLT treatment

Secondary Outcomes (2)

• Change in mean intraocular pressure (IOP)

  Measured at baseline and at 6 months post-DSLT treatment

• Proportion and absolute number of eyes achieving a reduction in IOP fluctuations of ≥1 mmHg 6 months post-DSLT.

  Measured at baseline and at 6 months post-DSLT treatment

Other Outcomes (1)

• Demographic variables associated with ≥1mmHg diurnal IOP fluctuation reduction.

  Measured at baseline and at 6 months post-DSLT treatment

Study Arms (1)

Voyager DSLT

Prospective, single-center, single arm, observational study

Device: Voyager DSLT

Interventions

Voyager DSLT DEVICE

Voyager DSLT

Voyager DSLT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older diagnosed with OAG or OHT, eligible for DSLT treatment.

You may qualify if:

• Visit 1 (Screening)
• Subject status as follows:
• Male or female, 18 years of age or older.
• Able and willing to attend scheduled follow-up exams for 6 months post-operatively.
• Able and willing to provide written informed consent on the IRB-approved Informed Consent Form.
• Diagnosis of OAG (i.e., primary, pseudoexfoliation, or pigmentary glaucoma) of any severity or OHT in the study eye (i.e., eye to undergo surgery).
• IOP-lowering medication regimen in the study eye as follows:
• a. Zero to three topical IOP-lowering medication classes at the time of Visit 1 (Screening) exam (Note: fixed combination medications \[e.g., Cosopt®, Combigan®, Rocklatan®, Simbrinza®\] count as two medications).
• Angle anatomy in the study eye defined as follows:
• Trabecular meshwork visible on gonioscopy defined by Shaffer grade ≥ 3.
• Normal anatomy as determined by gonioscopy.
• Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper DSLT treatment.
• Visit 2 (Baseline/Treatment)
• Medicated mean diurnal IOP (based on 8AM, 10AM and 4PM assessments) of ≥ 16 mmHg and less than or equal to 30 mmHg.
• Able and willing to attend scheduled follow-up exams for 6 months post-operatively.

You may not qualify if:

• Visit 1 (Screening)
• Status in the study eye as follows:
• Traumatic, malignant, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders.
• Functionally significant visual field loss, including severe nerve fiber bundle defects.
• Visual field (mean deviation) worse than -20 dB using 24-2 SITA Standard or equivalent.
• Prior incisional glaucoma surgery or ALT, or prior MIGS surgery.
• History of iridotomy, SLT, or MicroPulse Laser Trabeculoplasty (MLT) within the past 2 years.
• Unable to provide an adequate and interpretable visual field examination result (i.e., fixation losses, false positives and false negatives must all be less than 33%) in the study eye.
• Vertical C/D ratio \> 0.8 in the study eye.
• Presence of retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
• Corneal status in the study eye as follows:
• Any active inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis).
• Corneal endothelial dystrophy (e.g., bullous keratopathy, Fuch's dystrophy, guttata).
• Prior corneal transplantation, or endothelial cell transplants (e.g., Descemet's Stripping Automated Endothelial Keratoplasty \[DSAEK\]).
• Significant scarring or irregularities (including scars from prior corneal surgery such as PKP, RK, etc.) that may interfere with reliability of applanation IOP measurement anticipated corneal surgery of any type (including LASIK, LASEK, PRK, etc.).

Sponsors & Collaborators

• Ophthalmology Associates, Fort Worth: lead
• Sengi: collaborator

Study Sites (1)

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Brian Flowers, MD

  Ophthalmology Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlin Sinclair

CONTACT

(817)332-2020; ksinclair@oafw2020.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 24, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): April 3, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)