BLOG: Forthcoming study, real-world data registry validate safety of office-based surgery
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Safety is the most critical data point with respect to ophthalmic office-based surgery being accepted as an option for surgeons who are considering adding an in-office surgical suite to their practice.
Later this quarter, a multicenter study evaluating the safety of office-based surgery (OBS) will be published in a peer-review journal. The study, which includes case records of 18,005 consecutive patients who underwent OBS for visually significant cataract, refractive lens exchange (RLE) or phakic IOL implantation at 36 participating sites across the United States, found that ophthalmic OBS is as safe as or safer than any lens-based ophthalmic surgery previously reported in the literature. Outcome measures included the assessment of intraoperative and postoperative complications such as the incidence of unplanned vitrectomy, iritis, corneal edema and endophthalmitis following lens surgery.
The OBS multicenter registry was not limited by FDA protocols because all the procedures and technology involved in the study are already FDA approved. Anyone familiar with the steps involved in an FDA clinical trial knows that the findings that emerge after the trial are often the most useful. Without strict clinical trial parameters framing the analysis, real-world data (RWD) as it’s known, paints a bigger picture that offers deeper perspective on all of the elements involved in the investigation. Concurrent to the OBS lens surgery safety study, iOR Partners developed a RWD registry. The iRWD Registry is an ongoing compendium of how modern ophthalmic surgeons practice throughout the specialty.
As we add data to the iRWD — which now includes more than 30,000 cases — the registry continues to show that OBS is as safe as or safer than ophthalmic lens surgeries performed in hospital outpatient departments and ASCs. So, it clearly validates that it is safe to perform lens implant surgery on appropriate patients in an accredited OBS suite. But, in addition to this vital safety data, other information uploaded to the registry is proving invaluable. Among other things, the registry tracks which surgical technique was used, which patients received intracameral antibiotics, which lens implants and other products were used, as well as the age of the patient and their general and ocular comorbidities. To populate the registry, iOR Partners provides participating OBS practices with an iPad and software system to be used in the operating room. The surgeon inputs the data, which are then confidentially transferred into a HIPAA-compatible database.
The outcomes and trends emerging from retrospective analysis of the registry offer unique observations. For example, iRWD revealed that OBS safety outcomes were the same for patients in the Medicare age range of 65 years or older as they were for younger patients. Another example of data unique to the iRWD Registry is a compilation of outcomes from 5,000 RLE procedures. Office-based glaucoma, retina, oculoplastics and cornea procedures are also being gathered. With respect to this data, we are looking at parameters such as whether surgery was bilateral or eyes were done separately and what type of anesthesia was used — topical, local or standby.
The iRWD Registry stands to provide a rich field of information on RLE, ICL and other procedures that is currently lacking in the literature. The registry has already proved invaluable in validating the safety of office-based cataract surgery and will continue to serve as a record of OBS safety — and other parameters — on a grander scale as this model becomes more widely accepted as the next logical evolutionary development in ophthalmic surgery.
Reference:
- Real-world data collection for ophthalmic office-based surgery. https://iorpartners.com/knowledge-resources/white-papers-presentations-case-studies/ior-partners-obs-occurrence-data/. Accessed March 2, 2023.
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