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What Real-World Evidence Means for the Future of Glaucoma Treatment

Author: Mike Mbagwu, MD
February 2022
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The landscape of surgical glaucoma treatment has shifted rapidly in recent years, with movement towards earlier intervention with minimally invasive glaucoma surgery (MIGS) in appropriate patients. Analyses from the American Academy of Ophthalmology IRIS Registry (Intelligent Research In Sight) presented at the virtual 2021 American Glaucoma Society meeting showed a twofold increase in the use of MIGS from 2013 to 2018. 

Traditional filtration surgeries to reduce intraocular pressure in patients with glaucoma – such as trabeculectomies – are generally regarded as more invasive treatments with a greater risk profile. They are now typically performed only after other treatment methods were unsuccessful.

Now, due to advances in MIGS, interventions for patients with glaucoma can occur much earlier in the course of their disease. This has the benefit of slowing down and in some cases stabilizing glaucomatous disease progression, and maintaining eyesight.

The development of new treatments and surgical options is driving expansion within the glaucoma market – particularly the introduction of new devices. Now, due to advances in MIGS, interventions for patients with glaucoma can occur much earlier in the course of their disease. This has the benefit of slowing down and in some cases stabilizing glaucomatous disease progression, and maintaining eyesight.

The challenge for ophthalmologists, patients with glaucoma, life sciences companies, and health insurers, has been that most MIGS procedures are relatively new and are often performed alongside (and approved with) cataract procedures. Consequently, much remains unknown about the effectiveness of these procedures compared to one another, which types of patients each procedure can most benefit, and at what point in the course of  a patient’s disease would performing each procedure give maximal benefit.

The State of MIGS Procedures

MIGS procedures are performed by using microscopic-sized equipment and very small incisions. MIGS procedures have a lower risk profile for serious complications versus trabeculectomies. Clinicians and patients, however, must weigh the careful balance of trading some degree of effectiveness for increased safety, according to the Glaucoma Research Foundation

MIGS procedures received some attention recently when the U.S. Centers for Medicare and Medicaid Services (CMS) proposed a cut to the 2022 Medicare Physician Fee Schedule associated with some MIGS procedures. Specifically, the proposal would have reduced reimbursement by 90% for implanting an aqueous drainage device in combination with cataract surgery. While this initial proposal was amended prior to being instituted, it stands to reason that even more cuts to reimbursement may occur in the near future.

The controversy over the fee cut highlights the need for real-world evidence to enable clinicians and researchers to evaluate the effectiveness of various MIGS procedures. 

Verana Health Helps Deliver Quality MIGS Insights

Verana Health has partnered with the American Academy of Ophthalmology to manage the IRIS Registry, the nation’s first comprehensive eye disease clinical registry and the largest specialty clinical database in medicine. The IRIS Registry contains up to nine years of longitudinal records involving hundreds of millions of patient encounters from more than 15,000 clinicians.

VeraQTM, Verana Health’s population health data engine, takes detailed IRIS Registry clinical data collected from de-identified patient records and ingests, links and curates the data to create QdataTM, fit-for-purpose, quality data sets ready for life sciences analysis. Qdata goes beyond the diagnosis and treatment information contained in solely claims data to deliver deeper insight on real-world outcomes associated with various MIGS procedures. 

IRIS Registry data provides an average length of glaucoma patient follow-up that is substantial enough to show not just the short-term intraocular pressure (IOP) for one or a few clinic visits, but longer-term IOP control and/or additional glaucoma procedures performed in the future.

Qdata Glaucoma—leveraging the IRIS Registry and linked with medical and pharmacy claims—enables researchers to identify specific de-identified patient cohorts to study and develop a greater understanding of MIGS procedures and other glaucoma treatment patterns and outcomes. IRIS Registry data provides an average length of glaucoma patient follow-up that is substantial enough to show not just the short-term intraocular pressure (IOP) for one or a few clinic visits, but longer-term IOP control and/or additional glaucoma procedures performed in the future.   

What Life Sciences Can Learn from Real-world MIGS Data 

For life sciences companies, this data can be a valuable source for a host of insights about market trends, including which MIGS procedures are most frequently adopted, which types of patients benefit most from different modalities, and which clinicians are performing which MIGS procedures – to cite just a few. Also valuable for life sciences companies is the ability to swiftly conduct postmarketing safety surveillance using the real-world evidence drawn from a more diverse and representative population, rather than enrolling patients one by one in a clinical study in the hopes of capturing potentially rare side effects.

To that end, Verana Health recently launched its MIGS PRO Field Testing Study, an analysis of evolving MIGS treatment patterns and subsequent patient reported experiences that are informed by IRIS Registry data and patient surveys. 

Verana Health began the project by developing a dynamic algorithm using electronic health records (EHRs) to identify and engage with high-volume MIGS practice sites for patient recruitment. Currently, Verana Health is working closely with those sites and making progress towards its recruitment goal. 

The study will enable Verana Health to explore the different ways that IRIS Registry data can be used to provide insights on the rapidly changing MIGS landscape and to build relationships with practices and life science companies who are at the forefront of the field. This study is one of many varying use cases for real-world data in glaucoma with surgical and therapeutic innovation as the standard of care continues to evolve.If you’d like more information on leveraging real-world glaucoma data to inform your research, please take a moment to fill out this form.