GlaucomaNCT07428668
Change in IOP Fluctuation After DSLT
An observational study of Glaucoma, run by Ophthalmology Associates, Fort Worth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Voyager DSLT
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to 3 Apr 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older diagnosed with OAG or OHT, eligible for DSLT treatment.
Who may be able to join
- 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).
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- IOP-lowering medication regimen in the study eye as follows:
- 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.
- Successful DSLT treatment.
Who cannot join
- 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.
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- 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.).
- Lens status in the study eye:
- Visually significant cataract expected to require cataract surgery within the next 6 months.
- Cataract surgery within 24 months prior to Visit 1 (Screening).
- Anterior chamber intraocular lens (IOL) or implantable contact lens.
- Congenital or traumatic cataract (except Mittendorf dots).
- Choroidal detachment, effusion, choroiditis, neovascularization, or any active choroidopathy.
- Retinal or optic nerve disorders in either eye, either degenerative or evolutive, that are not associated with the existing glaucoma condition, including proliferative diabetic retinopathy (mild background diabetic retinopathy permissible), central retinal artery occlusion, central retinal vein occlusion, wet age-related macular degeneration, advanced dry age-related macular degeneration, (e.g., presence of numerous large drusen associated with disturbance to or elevation of the retinal pigment epithelium), significant retinal pigment epithelial changes or optic atrophy.
- Other ocular status in the study eye as follows:
- Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma).
- History of chronic ocular inflammatory disease or presence of active ocular inflammation (e.g., uveitis, iritis, iridocyclitis, retinitis, ocular herpes).
- Prior administration of a glaucoma stent (e.g., iStent, Hydrus Microstent).
- Prior administration of an intracameral implant or drug product (e.g., Travoprost Intraocular Implant, Durysta [bimatoprost intracameral implant], Dexycu [dexamethasone intraocular suspension]).
- Any pathology for which, in the investigator's judgment, the following would be either at risk or contraindicated:
- Implantation of iStent infinite. ii. Implantation of a Travoprost Intraocular Implant. iii. Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits).
- Fellow eye status as follows:
- Best spectacle corrected visual acuity of worse than 20/200.
- Fellow eye actively enrolled in this trial or any other clinical trial.
- Subject status as follows:
- Breast-feeding, pregnant or planning to become pregnant during the course of the study.
- Uncontrolled systemic disease (e.g., diabetes, hypertension) that could compromise participation in the study.
- Immunodeficiency conditions.
- Use within 30 calendar days of Visit 1 (Screening) or anticipated use during the study of any ophthalmic steroid, or any oral, parenteral, injected, or orally inhaled steroid medication that may cause an increase in IOP. Note: Nasally inhaled steroids are acceptable, as are topical dermal steroids provided they are not applied to the face.
- Current participation in any study, or participation within 30 days of Visit 1 (Screening).
- Current (within 30 days) or anticipated use of systemic acetazolamide or methazolamide.
- Change in an existing chronic systemic therapy that could substantially affect IOP or the study outcomes within 30 days prior to Visit 1 (Screening), or anticipated change during the study.
- Any ocular disease or condition that, in the opinion of the Investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
- CCT>620.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ophthalmology Associates
Fort Worth, Texas, 76102
Kaitlin Sinclair
Brian Flowers, MD
About this study
Official title: Change in Diurnal Intraocular Pressure Fluctuation Following Direct Selective Laser Trabeculoplasty
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
- Being tested
- Voyager DSLT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voyager DSLTDevice
Voyager DSLT
| Study group | Role | What they receive |
|---|---|---|
| Voyager DSLT | Prospective, single-center, single arm, observational study Receives: Device: Voyager DSLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diurnal intraocular pressure (IOP) fluctuation
Measured: Measured at baseline and at 6 months post-DSLT treatment
Secondary outcomes (2)
Change in mean intraocular pressure (IOP)
Measured: 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: Measured at baseline and at 6 months post-DSLT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start2 Apr 2026
- Primary completion3 Apr 2027 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmology Associates, Fort Worth
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Brian Flowers, MD, Principal investigator, Ophthalmology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428668
- Sponsor's protocol ID
- BF-26-01
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Diurnal Intraocular Pressure Fluctuation Following Direct Selective Laser Trabeculoplasty
- ClinicalTrials.gov ID
- NCT07428668
- Acronym / sponsor ID
- BF-26-01
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ophthalmology Associates, Fort WorthUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 3 Apr 2027 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 24 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voyager DSLT | – | Device: Voyager DSLTProspective, single-center, single arm, observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older diagnosed with OAG or OHT, eligible for DSLT treatment.
Key inclusion criteria (16 listed)
- Visit 1 (Screening)
- Subject status as follows:
- 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:
- Angle anatomy in the study eye defined as follows:
Key exclusion criteria (42 listed)
- Visit 1 (Screening)
- Status in the study eye as follows:
- 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.
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 |
|---|---|---|
| Voyager DSLTVoyager DSLT | Device | Voyager DSLT |
Primary outcome
Change in diurnal intraocular pressure (IOP) fluctuation
Time frame: Measured at baseline and at 6 months post-DSLT treatment
2 secondary outcomes
Change in mean intraocular pressure (IOP)
Time frame: 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.
Time frame: Measured at baseline and at 6 months post-DSLT treatment
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 20 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Brian Flowers, MD principal investigator
Ophthalmology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Ophthalmology Associates, Fort Worth at 1 site 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 16 inclusion and 42 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kaitlin Sinclair ((817)332-2020, ksinclair@oafw2020.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diurnal intraocular pressure (IOP) fluctuation (time frame: Measured at baseline and at 6 months post-DSLT treatment). 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 20 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.