NCT06991270

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026May 2027

First Submitted

Initial submission to the registry

May 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

May 19, 2025

Last Update Submit

January 12, 2026

Conditions

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Primary Effectiveness Endpoint

    Proportion of subjects with a ≥ 20% reduction from baseline in mean IOP at the 3-month post-operative endpoint and on the same or fewer medications as preoperatively.

    3 months

Secondary Outcomes (2)

  • Secondary Effectiveness Endpoint 1

    3 months

  • Secondary Effectiveness Endpoint 2

    3 months

Other Outcomes (2)

  • Safety Endpoint

    3 months

  • Safety Endpoint

    3 months

Study Arms (1)

OMNI 3.0

EXPERIMENTAL

Canaloplasty and trabeculotomy using the OMNI 3.0 surgical system, combined with phacoemulsification cataract surgery, OR as a standalone procedure in pseudophakic eyes.

Device: OMNI 3.0 Surgical System

Interventions

OMNI 3.0 Surgical SystemDEVICE

Canaloplasty and trabeculotomy.

OMNI 3.0

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, 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 of components), with a stable medication regimen for ≥2 months.
  • 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

You may not qualify 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), ≤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 the subject at risk of significant vision loss during the study period (e.g., wet age-related macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits). Dry AMD and Non- proliferative diabetic retinopathy are not excluded.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panama Eye Center

Panama City, Panama

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Jaime Dickerson, PhD

CONTACT

+1 (817) 845-0859jdickerson@sightsciences.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 27, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

PA(1)