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Spotlight on OMNI® Edge Surgical System

Ophthalmology 360

This Spotlight Series article is editorially independent content supported by Sight Sciences.

The primary goal of glaucoma surgery is to enhance the outflow of aqueous humor and reduce intraocular pressure (IOP) to levels that support optic nerve health. The development of microinvasive glaucoma surgery (MIGS) has transformed the treatment landscape, positioning surgical intervention as a viable option in the early stages of the disease. This shift has been driven by MIGS’ strong safety profile, proven effectiveness, and minimal disruption and trauma to ocular tissues.1,2

OMNI® Edge Surgical System: Enhanced Control and Versatility

Sight Sciences introduced a new addition to its OMNI product line—OMNI Edge Surgical System at the 2025 American Society of Cataract and Refractive Surgery Annual Meeting. OMNI Edge is indicated for canaloplasty followed by trabeculotomy to reduce IOP in adults with primary open-angle glaucoma (POAG). The device is only indicated for use with cohesive viscoelastic fluid; it’s not advised for use with dispersive viscoelastic fluid or visco-adaptive fluids.3,4

Building on the original OMNI Surgical System, OMNI Edge features TruSync™ technology for precise, synchronized viscoelastic delivery and nearly double the capacity (21 µL). Designed for versatility in MIGS, the OMNI Edge reduces IOP by addressing all 3 primary resistance areas in the aqueous outflow system: the trabecular meshwork, Schlemm’s canal, and the collector channels. The system is adaptable to various stages of POAG and can be used as a standalone treatment or in combination with cataract surgery.3

Efficacy Data

Multiple studies have demonstrated the safety, effectiveness, and durability of the OMNI procedure in both standalone and combination cataract procedures, including the ROMEO study.

ROMEO Study

ROMEO was a multicenter, retrospective, observational, consecutive study of patients treated with the OMNI Surgical System from 11 ophthalmic practices in 8 states. A total of 129 patients aged 45 years and older who met the inclusion criteria were enrolled. Inclusion criteria incorporated patients who:4

  • Underwent transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System with at least 273 to 456 days of follow-up
  • Had a visually significant cataract or were pseudophakic at the preoperative visit
  • Were diagnosed with OAG, including pigmentary and pseudoexfoliative glaucoma
  • Had visual field mean deviation not worse than –12 dB
  • Were on zero to 4 topical ocular hypotensive agents
  • Had open angles (Shaffer grade ≥3)

Postoperative follow-up examinations were performed at 1, 6, and 12 months. The findings showed that the combination of canaloplasty followed by trabeculotomy with the OMNI system provided effective IOP reduction, sustained IOP control, and meaningful reduction in medication for up to 12 months postoperatively.4

The results for the subgroup of patients with baseline IOP ≥16 mmHg are shown in TABLE 1.4

 

A post-hoc responder analysis was also conducted to evaluate the proportion of patients who experienced a ≥20 reduction in IOP at month 12, had no increase in medication, and had no secondary surgery. The results in patients who had OMNI performed as a standalone procedure and in conjunction with cataract surgery are shown in TABLES 2 and 3.4

 

 

Contraindications

The Instructions for Use for the OMNI Edge includes a few contraindications. The system should not be in any situations where the iridocorneal angle is compromised or damaged, in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlets canals with plateau iris, or in quadrants with previous MIGS implants.4

Safety and Tolerability

Overall, the procedure was well-tolerated. Adverse events (AEs) for the 129 patients were reported for the study eye only and classified as intraoperative or postoperative. All reported AEs were nonserious, with 44.2% of patients experiencing ≥1 AEs and 55.8% experiencing no AEs. The most common AEs included posterior capsule opacity (14.7%), mild anterior chamber inflammation (10.9%), cystoid macular edema (5.4%), corneal edema (4.7%), and IOP >10 mmHg above baseline >30 days postoperatively.4

To download the OMNI Edge Instructions for Use, visit https://omnisurgical.com/instructionsforuse.

References

  1. Hirsch L, Cotliar J, Vold S, et al. Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study. J Cataract Refract Surg. 2021;47(7):907-915. doi:10.1097/j.jcrs.0000000000000552
  2. Vold SD, Williamson BK, Hirsch L, et al. Canaloplasty and trabeculotomy with the OMNI system in pseudophakic patients with open-angle glaucoma: the ROMEO study. Ophthalmol Glaucoma. 2021;4(2):173-181. doi:10.1016/j.ogla.2020.10.001
  3. Sight Sciences to debut OMNI® Edge Surgical System at the 2025 ASCRS Annual Meeting, expanding the OMNI product portfolio. News release, Sight Sciences Inc; April 21, 2025. Accessed June 10, 2025. https://www.sightsciences.com/us/sight-sciences-to-debut-omni-edge-surgical-system-at-the-2025-ascrs-annual-meeting-expanding-the-omni-product-portfolio/
  4. OMNI Edge Surgical System Instructions for Use. Sight Sciences; 2025.

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