In a recent press release, the AAO announced that its patient-reported outcome measure for premium IOLs won FDA designation as a Medical Device Development Tool (MDDT). The designation allows medical device sponsors to use the Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) to clinically evaluate patients’ perception of visual disturbances following premium IOL cataract surgery.

Whereas clinical studies previously relied on safety endpoints based on traditional IOLs, the AAO says the AIOLIS enables researchers to analyze patient symptoms and promote the patient's experience of their premium IOLs during the regulatory decision-making process. 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.

AIOLIS is the product of a collaboration among the AAO, David Geffen School of Medicine at UCLA, Ron D. Hays, PhD, an expert in patient-reported outcomes, RAND, and IOL manufacturers Alcon, Bausch + Lomb, Carl Zeiss Meditec AG and Johnson & Johnson Vision. It was field tested by 20 cataract surgeons in sites across the United States and two international sites.