Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
NCT06991270

OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma

Led by Sight Sciences, Inc. · Updated on 2026-01-14

25

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects, 45 years or older
  • Visually significant age-related cataract requiring phacoemulsification cataract surgery, OR pseudophakic with at least six months since cataract surgery
  • Intraocular pressure (IOP) at screening not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or at least 16 mmHg if medicated with 1 to 4 ocular hypotensive medications
  • Stable glaucoma medication regimen for 2 months or more
  • Diagnosed with mild to moderate primary open-angle glaucoma with glaucomatous optic nerve damage or visual field defect consistent with glaucoma
Not Eligible

You will not qualify if you...

  • Prior ocular procedures including laser trabeculoplasty within 180 days, Durysta within 12 months, any implanted glaucoma device, prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy
  • Ciliary ablation procedures including endoscopic cyclophotocoagulation, cyclophotocoagulation, or high intensity focused ultrasound within 180 days
  • Retinal laser procedures within 3 months
  • Any glaucoma type other than primary open-angle glaucoma
  • Use of topical ocular steroids
  • Clinically significant ocular or systemic conditions increasing risk or interfering with study compliance (e.g., wet age-related macular degeneration, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days)
  • History of penetrating keratoplasty or corneal transplant
  • Corneal abnormalities preventing reliable IOP measurement, including keratoconus or abnormal corneal thickness (≥620 µM or ≤480 µM)
  • Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome, or conditions causing elevated episcleral venous pressure
  • Best corrected visual acuity (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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Panama Eye Center

Panama City, Panama

Actively Recruiting

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Research Team

J

Jaime Dickerson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma | DecenTrialz