Standalone OMNI Surgical System for Open-angle Glaucoma

Open Angle Glaucoma Clinical Trial

— OMNIgl  

Official title:

Standalone OMNI Surgical System for Open-angle Glaucoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04427995
• Other study ID #: 948
• Status: Terminated
• Start date: March 25, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: July 2021
• Source: Prism Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: April 1, 2021
• Est. primary completion date: March 31, 2021
• Gender: All
• Age group: 30 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Device:
• OMNI surgical system
GATT + viscodilation

Locations

Country	Name	City	State
Canada	Prism Eye Institute	Oakville	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Iqbal Ahmed	OMNI Medical Services, LLC

Country where clinical trial is conducted

Canada, 

References & 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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.00000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Examine the adverse event profile of the OMNI surgical system in patients with open angle glaucoma.	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

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