A 2021 retrospective analysis of more than 200,000 patients who underwent minimally invasive glaucoma surgery (MIGS) from 2013 to 2018 determined that the use of MIGS procedures increased more than fivefold during that time period, yet we are still learning about which patients stand to benefit the most from MIGS. The study’s authors concluded that this significant increase in MIGS procedures called for trials comparing outcomes “of novel MIGS versus traditional surgical treatments for glaucoma.”
Sight Sciences and Verana Health answered the call with a comparative outcomes study that evaluates and compares intraocular eye pressure (IOP) and medication reduction as clinical outcomes among FDA-approved or cleared MIGS used in combination with cataract surgery versus cataract surgery alone at pre-specified time points up to 24 months. This is the first real-world evidence (RWE) study of its kind to help the ophthalmology community and other stakeholders understand how MIGS procedures fit into the glaucoma treatment landscape. Read our white paper detailing this study here.
As did the 2021 retrospective study, the Sight Sciences/Verana Health analysis relied on curated real-world data (RWD) from the American Academy of Ophthalmology (Academy) IRIS® Registry (Intelligent Research in Sight). Our joint study reviewed effectiveness data from FDA-approved or cleared ab-interno MIGS devices within the IRIS Registry’s real-world database from 2018 to 2020.
Identifying the right RWD to understand efficacy
While there is no cure yet for glaucoma, appropriate treatment can slow down vision loss. Unfortunately, treatment options such as prescription eye drops, oral medications and invasive surgery can be challenging for glaucoma patients for a variety of reasons. As a practicing ophthalmologist, I see how difficult it is for some patients to undergo surgery, or to place drops in their eyes and adhere to a dosage schedule. Based on IRIS Registry data, the average age of a patient receiving an initial glaucoma procedure is 71 years old. They may also have other medical comorbidities that further limit treatment options.
We must do more for the 3 million Americans and 80 million people worldwide with glaucoma.
We must do more for the 3 million Americans and 80 million people worldwide with glaucoma. That’s why our research collaboration with Sight Sciences is so important. Sight Sciences is leveraging Verana Health’s Qdata® Glaucoma RWD data module to develop data to further support the efficacy of its OMNI® Surgical System – a minimally invasive, implant-free glaucoma procedure that uniquely addresses all three known points of resistance in the aqueous outflow system: the trabecular meshwork, Schlemm’s canal and the collector channels. IOP is the only known modifiable risk factor for glaucoma, and OMNI enables surgeons to reduce IOP while avoiding more aggressive surgical interventions or foreign body implants associated with legacy MIGS procedures. OMNI is indicated for canaloplasty followed by trabeculotomy, and can be used before, in combination with, or following cataract surgery.
“We may have been able to do this project on our own, but it would have required several vendors and subpar data sources — it is just time consuming and expensive. The attractiveness of working with Verana Health and the IRIS Registry besides its unmatched credibility is their ability to perform more frequent data refreshes, handle electronic health records in a compliant and consistent manner, and leverage artificial intelligence to conduct a more thorough analysis of ophthalmologists’ clinical notes all under one roof.”John Liu, Senior Vice President
Global Market Access at Sight Sciences
Citing Verana Health’s “unmatched credibility,” Sight Sciences chose our company as its glaucoma research partner because of our partnership with the Academy and our ability to curate data from the IRIS Registry using the Qdata Glaucoma module. With nine years of longitudinal data on more than 75 million de-identified patients from approximately 16,000 participating clinicians, the IRIS Registry is one of the largest specialty society clinical data registries in all of medicine and the first comprehensive eye disease clinical registry in the U.S.
American Academy of Ophthalmology IRISⓇ Registry (Intelligent Research in Sight) Industry Report 2021
Learn more about why Sight Sciences selected Verana Health, as well as details on the comparative MIGS study using IRIS Registry data, in this case study.