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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voyager DSLT | Prospective, single-center, single arm, observational study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voyager DSLT | Device | Voyager DSLT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in diurnal intraocular pressure (IOP) fluctuation | Measured at baseline and at 6 months post-DSLT treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic variables associated with ≥1mmHg diurnal IOP fluctuation reduction. | Measured at baseline and at 6 months post-DSLT treatment |
Inclusion Criteria:
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:
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:
Visit 2 (Baseline/Treatment)
Exclusion Criteria:
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.
Corneal status in the study eye as follows:
Lens status in the study eye:
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:
i. 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:
Subject status as follows:
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Adults aged 18 years or older diagnosed with OAG or OHT, eligible for DSLT treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaitlin Sinclair | Contact | (817)332-2020 | ksinclair@oafw2020.com |
| Name | Affiliation | Role |
|---|---|---|
| Brian Flowers, MD | Ophthalmology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Associates | Recruiting | Fort Worth | Texas | 76102 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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