NCT04427995

Brief Summary

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.

Trial Health

57
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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

June 5, 2020

Last Update Submit

July 19, 2021

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Lower Intraocular Pressure and medication dependence

    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 Outcomes (1)

  • Examine the adverse event profile of the OMNI surgical system in patients with open angle glaucoma.

    1 month post operatively

Study Arms (1)

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

Interventions

OMNI surgical systemDEVICE

GATT + viscodilation

Also known as: OMNI surgical systems
Oen Angle Glaucoma

Eligibility Criteria

Age30 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prism Eye Institute

Oakville, Ontario, L6H 0J8, Canada

Location

Related Publications (4)

  • Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.

    PMID: 28237137RESULT

  • Francis BA, Akil H, Bert BB. Ab interno Schlemm's Canal Surgery. Dev Ophthalmol. 2017;59:127-146. doi: 10.1159/000458492. Epub 2017 Apr 25.

    PMID: 28442693RESULT

  • Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, Montes de Oca I, Feuer WJ. Gonioscopy-assisted Transluminal Trabeculotomy: An Ab Interno Circumferential Trabeculotomy: 24 Months Follow-up. J Glaucoma. 2018 May;27(5):393-401. doi: 10.1097/IJG.0000000000000956.

    PMID: 29613978RESULT

  • Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm's canal for the reduction of IOP via an ab-interno approach. Clin Ophthalmol. 2018 Oct 23;12:2149-2155. doi: 10.2147/OPTH.S177597. eCollection 2018.

    PMID: 30425450RESULT

Related Links

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Iqbal Ahmed, MD

    Prism Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 11, 2020

Study Start

March 25, 2019

Primary Completion

March 31, 2021

Study Completion

April 1, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

CA(1)