Newswise — SAN FRANCISCO — The U.S. Food and Administration (FDA) last week qualified the American Academy of Ophthalmology’s patient-reported outcome measure for premium intraocular lenses (IOLs) as a Medical Device Development Tool (MDDT). The designation allows medical device sponsors to use the Academy’s Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) to clinically evaluate patients’ perception of visual disturbances following premium IOL cataract surgery. This is the second MDDT the Academy guided to approval, the first was the Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS).
The AIOLIS fills a gap in the evaluation of patient symptoms associated with premium IOLs. Clinical studies previously relied on safety endpoints based on traditional IOLs. Now, researchers have a tool that can be used in regulatory decision-making to promote the patient's point of view and experience of their premium IOLs.
The assessment tool is the result of a multi-year collaboration among the Academy, UCLA, Ron D. Hays, PhD, a leading expert in patient reported outcomes, RAND, and four IOL device manufacturers: Alcon, Bausch & Lomb, Carl Zeiss Meditec AG, and Johnson & Johnson. The AIOLIS instrument was field tested by 20 cataract surgeons in sites across the US and two sites outside of the US.
“This uniquely collaborative journey allowed us to recognize the great value in understanding the visual outcomes of premium IOL cataract surgery from patients' observations and to produce an instrument that reflects those findings,” said Samuel Masket, MD, lead for the AIOLIS development and clinical professor of ophthalmology at the David Geffen School of Medicine at UCLA. “At the end of the day, the devices that the manufacturers provide and what clinicians do at surgery must primarily benefit the patient and satisfy their visual needs.”
AIOLIS questions focus on 15 common symptoms, general vision perceptions, and the need for contact lenses or eyeglasses after surgery. Most symptoms — including floaters, glare, blurry vision, or double vision — include a written definition and a photograph to help patients more accurately identify the visual symptom they are experiencing.
The FDA created the MDDT program to offer pre-qualified evaluation tools to medical device sponsors. Once qualified, tools do not have to be reconfirmed. There are only two MDDTs in ophthalmology.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate and support research to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart® program provides the public with the most trusted information about eye health. For more information, visit aao.org.
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