---
title: A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
nct_id: NCT05044793
overall_status: COMPLETED
sponsor: Sight Sciences, Inc.
study_type: OBSERVATIONAL
primary_condition: Glaucoma, Open-Angle
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05044793.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05044793"
ct_last_update_post_date: 2025-01-22
last_seen_at: "2026-05-12T06:38:57.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System

**Official Title:** A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)

**NCT ID:** [NCT05044793](https://clinicaltrials.gov/study/NCT05044793)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 70
- **Lead Sponsor:** Sight Sciences, Inc.
- **Conditions:** Glaucoma, Open-Angle
- **Start Date:** 2021-09-01
- **Completion Date:** 2023-08-21
- **CT.gov Last Update:** 2025-01-22

## 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

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

* 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)
```

## Arms

- **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.
- **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.

## 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.

## Primary Outcomes

- **Primary Safety Endpoint** _(time frame: 12 months)_ — Rate of occurrence of sight-threatening adverse events

## Locations (4)

- Grene Vision Group, Wichita, Kansas, United States
- Oklahoma Eye Surgeons, Oklahoma City, Oklahoma, United States
- Northern Ophthalmics, Jenkintown, Pennsylvania, United States
- El Paso Eye Surgeons, El Paso, Texas, United States

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.grene vision group|wichita|kansas|united states` — added _(2026-05-12)_
- `locations.oklahoma eye surgeons|oklahoma city|oklahoma|united states` — added _(2026-05-12)_
- `locations.northern ophthalmics|jenkintown|pennsylvania|united states` — added _(2026-05-12)_
- `locations.el paso eye surgeons|el paso|texas|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05044793*  
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