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New treatment option for Primary Open Angle Glaucoma
Official title OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
ClinicalTrials.gov ID: NCT06991270
What this study is testing
- What it's testing
- To gain early evidence of safety and assess the effectiveness of the intraocular pressure (IOP)-lowering effectiveness of the OMNI 3.0 Surgical System in primary open-angel glaucoma (POAG).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- Male or female people, 45 years or older
- Visually significant age-related cataract and requiring phacoemulsification cataract surgery, OR, pseudophakic and a minimum of six months since...
- Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4...
- Diagnosed with mild to moderate primary open angle glaucoma (POAG). Diagnosis must include evidence of glaucomatous optic nerve damage or visual...
You likely can't join if
- Any of the following prior ocular procedures:
- Laser trabeculoplasty ≤180 days prior to baseline
- Durysta ≤12 months prior to baseline
- Any implanted glaucoma device
- Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy
- Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU)...
See the full eligibility criteria
- Male or female people, 45 years or older
- Visually significant age-related cataract and requiring phacoemulsification cataract surgery, OR, pseudophakic and a minimum of six months since cataract surgery.
- Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number...
- Diagnosed with mild to moderate primary open angle glaucoma (POAG). Diagnosis must include evidence of glaucomatous optic nerve damage or visual field defect consistent with glaucomatous optic nerve damage
- Any of the following prior ocular procedures:
- Laser trabeculoplasty ≤180 days prior to baseline
- Durysta ≤12 months prior to baseline
- Any implanted glaucoma device
- Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy
- Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU), ≤180 days prior to baseline
- Retinal laser procedure ≤3 months prior to baseline
- Any form of glaucoma other than POAG.
- Use of topical ocular steroids.
- Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place...
- History of penetrating keratoplasty or another corneal transplant; corneal abnormality that would prevent reliable IOP measurement, e.g. keratoconus or abnormally thick (≥ 620 µM) or thin (≤ 480 µM) cornea.
- Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
- BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract.
- BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
The study team makes the final eligibility decision.
Where it's taking place
- Panama City, Panama
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Panama City, Panama. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.