Standalone OMNI Surgical System for Open-angle Glaucoma (OMNIgl)

July 19, 2021 updated by: Iqbal Ahmed
The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP). The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising MIGS procedure. It combines two procedures known as trabeculotomy and viscodilation of Schlemm's canal in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for certain indications in ophthalmic surgery. To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP).1 The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising procedure which targets the conventional outflow pathway.2 This device treats the trabecular meshwork, Schlemm's canal and the distal collector channels, all conventional pathway points of aqueous outflow resistance. Its designed microcatheter allows for cannulation of Schlemm's canal, dilation using the controlled delivery of viscoelastic as well as a trabeculotomy by stripping the trabecular meshwork will retracting the catheter.3 Goniotomy-assisted transluminal trabeculotomy (GATT) has shown promising results in using an ab interno approach to cleave the trabecular meshwork.4 Alternatively, viscodilation alone has also shown an IOP lowering effect. 5 The OMNI Surgical System combines both procedures in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for delivery of small amounts of viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures.6 To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6H 0J8
        • Prism Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma with IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.
  • Exclusions: Other forms of glaucoma, prior incisional glaucoma surgery, prior corneal graft (PKP, DALK, DSAEK, DMEK), Shafer angle grading <2 in 2 or more quadrants.

Description

Inclusion Criteria

  • Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma.
  • An IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy.
  • Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.

Exclusion Criteria:

  • Other forms of glaucoma,
  • prior incisional glaucoma surgery,
  • prior corneal graft (PKP, DALK, DSAEK, DMEK),
  • Shafer angle grading <2 in 2 or more quadrants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Oen Angle Glaucoma
• Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma with IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.
Device: OMNI surgical system
GATT + viscodilation
Other Names:
  • OMNI surgical systems

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lower Intraocular Pressure and medication dependence
Time Frame: Postoperative week 1, month 1, month 3, annually
Change in IOP less than or equal to baseline with a medication reduction to 1 or less or an IOP change of 20% or less from baseline with medication
Postoperative week 1, month 1, month 3, annually

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Examine the adverse event profile of the OMNI surgical system in patients with open angle glaucoma.
Time Frame: 1 month post operatively

Absence of the following complications:

1. ) Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia, and/or; 2.) At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, endophthalmitis
1 month post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iqbal Ahmed

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
OMNI Medical Services, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Iqbal Ahmed, MD, Prism Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Angle Glaucoma

Clinical Trials on OMNI surgical system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings