ESCRS - PP15.16 - Omni® Surgical System: Preliminary Results From A Systematic Review Evaluating The Treatment Of Open-Angle Glaucoma

Omni® Surgical System: Preliminary Results From A Systematic Review Evaluating The Treatment Of Open-Angle Glaucoma

Published 2022 - 40th Congress of the ESCRS

Reference: PP15.16 | Type: ESCRS 2022 - Posters | DOI: 10.82333/prqs-k016

Authors: Dan Nguyen* 1 , Dan Lindfield 2 , Carolyn Steeds 3 , Michael Minshall 4

1Ophthalmology,Mid-Cheshire Hospitals NHS Trust,Crewe,United Kingdom, 2Ophthalmology,Royal Surrey County Hospital,Guildford,United Kingdom, 3Valid Insight,Macclesfield,United Kingdom, 4Sight Sciences,Menlo Park,United States

Purpose

Minimally invasive glaucoma surgery (MIGS) is recognised as an option for reducing intraocular pressure (IOP) in primary open angle glaucoma (POAG) patients. The OMNI® Surgical System is a MIGS device designed to perform both ab interno canaloplasty and trabeculotomy without leaving a foreign body in the eye and can be used in combination with cataract surgery or as a standalone procedure. The purpose of this systematic literature review (SLR) was to identify, quality-assess, and extract data on clinical, humanistic, economic outcomes on laser trabeculoplasty and MIGS, including the OMNI® Surgical System.

Setting

This SLR was conducted using published literature from Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Mexico, Poland, South Korea, Spain, Switzerland, United Kingdom, United States of America.

Methods

An SLR was conducted by searching MEDLINE®, EMBASE® and Cochrane databases for studies published in the English language from 2011-2021. Additionally, ClinicalTrials.gov and relevant conference databases from the last 3 years (2018-2021) were searched to retrieve additional studies of interest. Clinical outcomes of interest were change in IOP, reduction in number of medications after the procedure, and adverse events. Search included randomized controlled or single-arm trials, observational or cross-sectional studies, and SLRs with or without meta-analysis, as well as case series. Quality was assessed using standard risk of bias tools.

Results

Eight publications (7 studies) on the OMNI® Surgical System were identified, including 445 patients (490 eyes) overall. Study designs were retrospective observational (4 studies)/case series (1) and prospective clinical trial (1)/case series (1). All publications reported mean levels of IOP at different follow-up times compared to baseline.

- Mean (SD) baseline IOP ranged from 16.4 (4.6) to 24.6 (3.0) mmHg;

- Percent change from baseline was reported for five studies and ranged from:

- 41.4% (9.5) to -9.1% (26.8) at six months;

- 39.8% (10.6) to -12.0% (22.7) at twelve months;

- Reduction in use of IOP lowering medications at 12 months ranged from -1.9 (2.59 to 0.64), to -0.4 (1.7 to 1.2);

The OMNI® Surgical System showed a good safety profile.

Conclusions

This preliminary review of the published clinical data for the OMNI® Surgical System found it to be effective in reducing IOP and number of IOP lowering medications in patients with mild to moderate to POAG.

The OMNI® Surgical System demonstrated a favourable safety profile similar to other MIGS.

Studies reported the OMNI® Surgical System was equally effective when used in combination with cataract surgery or standalone. The OMNI® Surgical System is being further evaluated in RCTs compared with other MIGS at the present time.