A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System

NCT05044793 | Completed Results FDA Device

• 1 other identifier: 07408
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint

  Rate of occurrence of sight-threatening adverse events

  12 months

Other Outcomes (4)

• Change in Intraocular Pressure (IOP)

  12 months

• Change in Hypotensive Medications

  12 months

• Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months

  12 months

Study Arms (2)

Cohort A

Subjects who had a surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.

Device: OMNI® Surgical System

Cohort B

Subjects without a surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.

Device: OMNI® Surgical System

Interventions

OMNI® Surgical System DEVICE

The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Cohort A; Cohort B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who received treatment and completed Protocol #06213

You may qualify if:

• Participated in, received treatment, and completed Protocol #06213

You may not qualify if:

• Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits
• Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age 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)

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (4)

Grene Vision Group

Wichita, Kansas, 62708, United States

Location

Oklahoma Eye Surgeons

Oklahoma City, Oklahoma, 73112, United States

Location

Northern Ophthalmics

Jenkintown, Pennsylvania, 19406, United States

Location

El Paso Eye Surgeons

El Paso, Texas, 79902, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: VP, Medical and Clinical Affairs
• Organization: Sight Sciences, Inc.

jdickerson@sightsciences.com

1-877-266-1144

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 16, 2021
• Study Start: September 1, 2021
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)