In a recent presentation, three glaucoma experts discussed why they implemented the OMNI Surgical System (Sight Sciences; Figure 1) in their practices. They identified nine compelling reasons why the OMNI technology adds value to their practices while offering their patients a welcome alternative to medication management and minimally invasive treatment options.
Figure 1. The OMNI Surgical System.
Reason 1: Three Points Addressed
Philip Ngai, MD, MS, MBA: The OMNI technology uniquely addresses all three known points of resistance in the aqueous outflow system. It is the only MIGS device capable of addressing the trabecular meshwork, Schlemm's canal, and the distal collector channels at the same time. Because there is no practical way of diagnosing the location of the resistance in the conventional outflow pathway, addressing all three points of outflow resistance increases the odds of successfully lowering IOP with a single procedure.
Reason 2: elegant technology
Neda Shamie, MD: The OMNI Surgical System is an implant-free, MIGS technology indicated to treat primary open-angle glaucoma (POAG) via canaloplasty followed by trabeculotomy. The device combines these two functions into one elegant procedure. With the handheld device, the surgeon traverses the anterior segment, inserts the microcatheter into the Schlemm's canal, and performs manual dilation (Figure 2). Then, the surgeon may deliver a controlled amount of viscoelastic through the microcatheter to further remove resistance within Schlemm's canal and the collector channels. He or she performs the trabeculotomy by reinserting the microcatheter and then pulling back on the handpiece.
Figure 2. The OMNI Surgical System addresses all three known points of resistance in the aqueous outflow system.
Reason 3: Solo or In Combination
Noureen Khan, MD: OMNI can be used as a standalone option or in combination with cataract surgery. This versatility provides advantages for us as surgeons and for our patients. There is a large population (85%) of primary open-angle glaucoma patients who don’t yet need cataract surgery,1 and these individuals can benefit from a short and safe procedure that lowers their IOP. For those who have already received cataract surgery, the OMNI procedure is a minimally invasive procedure that offers the potential to reduce their dependence on IOP-lowering medications while enjoying quick recovery times and an attractive safety profile.
Reason 4: Versatility
Dr. Shamie: OMNI is a versatile technology that can be used at any stage of glaucoma. The procedure is customizable—the surgeon can tailor it to the needs of each particular eye. Its unique 360º access to the diseased conventional outflow pathway, in combination with its ability to address all three points of resistance, makes the procedure with OMNI ideal for treating a range of disease severity.
Reason 5: Ergonomics
Dr. Khan: The OMNI Surgical System is well-designed, ergonomic, and intuitive. The design of the Ergo-Series device maximizes ergonomics and surgical ease of use. Its beveled cannula tip allows for gentle and precise access into Schlemm's canal to create a precise otomy. The finger wheel, which advances the microcatheter, has enhanced prominence and wider ridges for improved tactile feel. In addition, the textured handle gives the surgeon a comfortable and secure grip during procedures. Finally, OMNI has a priming feature that allows for an easy attachment of the OVD-containing cartridge directly to the device. The OVD is then dispensed from an internal reservoir during the surgery, saving time and enhancing efficiency.
Reason 6: Implant-Free
Dr. Shamie: The OMNI Surgical System offers a MIGS procedure that is implant-free and has been proven safe and effective.2 The ROMEO extension study published in 2023 was designed to provide safety and effectiveness at 24 months postoperatively for two cohorts: canaloplasty followed by trabeculotomy in combination with cataract surgery and standalone canaloplasty followed by trabeculotomy in pseudophakic patients.3 The proportion of total patients at 2 years who met the primary success criteria (either a ≥20% IOP reduction or IOP between 6 and 18 mm Hg and no increase in medication or SSI) was 75%; the proportion of patients who met the success criteria and who either had cataract surgery plus OMNI or OMNI as a standalone procedure was 72.1% and 79.3%, respectively. Additionally, 33.3% of patients were medication-free at two years.3
Reason 7: Fewer Drops
Dr. Ngai: The OMNI Surgical System may reduce or eliminate patients’ dependence on topical IOP drop therapy. This potential benefit alleviates (or eliminates) the risk of patients’ nonadherence, and it generally makes for happy patients. In 2022, investigators in the GEMINI study evaluated the combined use of the OMNI Surgical System during cataract surgery on IOP and IOP-lowering medication use. At 12 months, 76% of the eyes had an IOP of between 6 and 18 mm Hg, 84.2% of the eyes achieved an IOP reduction of >20% from baseline, and 80% were free of IOP-lowering medications. Moreover, the investigators reported very few adverse events.2 These impressive data give me the confidence that I am making a difference in my patients’ lives.
Dr. Khan: The potential to reduce drop burden is a huge benefit for our patients. With all of the available minimally invasive glaucoma procedures to reduce pressure and lower drop burden, this should encourage a shift in surgeons’ mindsets on how to care for glaucoma patients: early in the disease progression.
Reason 8: Smooth Recovery
Dr. Ngai: Postoperative care after the OMNI procedure is like standard cataract surgery. Expectations for a smooth recovery may be challenging to maintain with traditional glaucoma procedures. However, MIGS performed with OMNI has a predictably smooth recovery process, even for challenging cases. When conditions such as hyperemia, a systemic inflammatory disease, or narrow eyelid fissures present challenges that may cause surgeons to hesitate to use conjunctival-based glaucoma procedures, surgery with OMNI is an excellent option.
Reason 9: Future Options
Dr. Khan: As we know, glaucoma management is a journey. The OMNI Surgical System does not preclude us from performing more advanced glaucoma procedures should they be needed in the future. This flexibility offers options to our patients that may not have been available before, and it can expand the scope of our practices and the value we can provide to our patients. By intervening early and using the OMNI to achieve meaningful IOP reduction, we surgeons can significantly impact the burden of future medical therapies, potentially decrease disease progression, potentially reduce drop noncompliance, and offer significant value to our patients.
1. Kwon H. Y, Fingert H. J, Greenlee C. E. Chapter 2: Epidemiology of glaucoma. In: A Patient’s Guide to Glaucoma. FEP International; 2008:11-18.
2. Gallardo MJ, Pyfer MF, Vold SD, et al. Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study. Clinical Ophthalmology. 2022;Volume 16:1225-1234. doi:10.2147/OPTH.S362932
3. Williamson BK, Vold SD, Campbell A, et al. Canaloplasty and Trabeculotomy with the OMNI System in Patients with Open-Angle Glaucoma: Two-Year Results from the ROMEO Study. Clinical Ophthalmology. 2023;Volume 17:1057-1066. doi:10.2147/OPTH.S407918
IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE: The OMNI Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
CONTRAINDICATIONS: Do not use the OMNI Surgical System in any situations where the iridocorneal angle is compromised or has been damaged (e.g., from trauma or surgery), since it may not be possible to visualize the angle or to properly pass the microcatheter. Do not use the OMNI Surgical System in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris. Do not use the OMNI Surgical System in quadrants with previous MIGS implants. Please visit OMNISurgical.com/ifu for the full instructions for use, warnings, precautions, and adverse event information.
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