The availability of MIGS procedures has expanded glaucoma surgeons’ treatment options for controlling patients’ IOP. Given the widespread implementation of various MIGS technologies, a need for robust, large-scale, real-world data has emerged. These types of studies are of critical importance in assessing the effectiveness and safety of different MIGS procedures beyond the trials necessary to receive either CE mark or FDA approval.
The Power of Real-World Data
A recent analysis examined post-surgical outcomes over 24 months in glaucoma patients treated with MIGS technologies—like the OMNI® Surgical System (Sight Sciences)—combined with cataract surgery, and those undergoing cataract surgery alone.1 An important aspect of this study was its use of independent data from the IRIS registry, the largest real-world data repository for eye care. This ensured a broad and inclusive representation of data from practices across the United States, enhancing the study’s relevance and applicability. By leveraging real-world data, this analysis provides valuable insights into the efficacy of the OMNI Surgical System in glaucoma management and can aid surgeons in making informed decisions regarding the best treatment options for their patients.
Clinical Outcomes
For the analysis, researchers looked at data from 77,391 patients (428 OMNI; 1,435 iStent inject [Glaukos]; 4,769 Hydrus [Alcon]; and 70,759 cataract surgeries alone). Outcomes included IOP and medication usage over 24 months, stratified by baseline IOP (≤18 and >18 mmHg). In the group of patients with IOP >18 mmHg, those undergoing an OMNI procedure with cataract surgery achieved an average IOP reduction of 6.6 mmHg at 24 months postoperatively (Figure 1). In addition, patients in this group observed an average reduction in medication usage of -1.34 at 24 months postoperatively.
This is an impactful finding because reducing medication burden is crucial for improving patients' quality of life, minimizing the negative impact of medications on the ocular surface, and addressing medication adherence issues.
Beyond these findings, the analysis revealed several other impressive findings. Although the OMNI Surgical System was primarily used for patients with mild to moderate glaucoma—who typically benefit most from MIGS—surgeons also employed it for patients with more advanced disease. This makes the substantial reductions in IOP and medication usage observed in the OMNI group particularly impressive. Additionally, in this study, the OMNI treatment arm included a higher proportion of African-American patients, who have a higher incidence of glaucoma and tend to develop glaucoma at a younger age. Despite these challenging patient characteristics, OMNI performed well in this demographic, highlighting its effectiveness across a diverse population.
From Real-World Data to Clinical Practice
I have been using the OMNI Surgical System for three years, and my clinical experience mirrors the outcomes shown in the data from the IRIS Registry. By performing a MIGS procedure using OMNI, I achieve powerful reductions in IOP and medication burden for my patients with open-angle glaucoma. Considering the negative effects of drops on patients’ ocular surface and overall quality of life, it is beneficial to have a viable MIGS treatment option for patients with both cataracts and glaucoma.
The OMNI Surgical System is also a great option for patients with well-controlled pressure who experience issues with their medication, such as tolerability or poor adherence, and can potentially enable them to eliminate the need for IOP-reducing medications. The surgery is typically well-tolerated and comfortable, with a postoperative recovery period comparable to cataract surgery alone, and OMNI, as a MIGS procedure, is known for its good safety profile.2
Unique Features of the omni surgical system
The OMNI Surgical System is a comprehensive MIGS technology for treating the full spectrum of open-angle glaucoma.2,3 It addresses all three areas of resistance in the conventional outflow system: the trabecular meshwork, Schlemm’s canal, and the collector channels (Figure 2). Another advantage of this technology is that it leaves no foreign body or implant behind, enhancing long-term safety and preserving future treatment options. The system is also easy to operate single-handedly without needing additional equipment or assistance from the scrub team.
The compelling real-world data from the IRIS study, combined with my own clinical experience, underscore OMNI's effectiveness and safety in managing glaucoma, providing a comprehensive treatment option that has the potential to significantly reduce IOP and medication burden for diverse patient populations.
©2024 Sight Sciences, Inc. CE2797
07/2024 OM-3231-OUS.v1.
1. Mbagwu M, Chapman R, Garcia K, et al. Ab interno minimally invasive glaucoma surgery combined with cataract surgery and cataract surgery alone: IRIS® registry study. AJO International. 2024;1(2):100015.
2. Yadgarov A, Dentice K, Aljabi Q. Real-world outcomes of canaloplasty and trabeculotomy combined with cataract surgery in eyes with all stages of open-angle glaucoma. Clin Ophthalmol. 2023;17:2609-2617
3. Dickerson JE Jr, Harvey AE, Brown RH. Ab interno canaloplasty and trabeculotomy outcomes for mild, moderate, and advanced open-angle glaucoma: A ROMEO analysis. Clin Ophthalmol. 2024;18:1433-1440.
Important Product Information
This information is intended solely for healthcare professionals located in the UK and EU. Patients should direct questions to their healthcare professional.
INDICATIONS FOR USE: The OMNI Surgical System is indicated for the catheterization and transluminal viscodilation of Schlemm’s canal and the cutting of trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.
For important product information including cautions and adverse events, please refer to the full instructions for use available at omnisurgical.com/international
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Andrew Tatham is a paid consultant of Sight Sciences, Inc