FDA Approves AAO’s Assessment Tool to Advance Premium IOL Cataract Surgery

The U.S. Food and Drug Administration (FDA) has qualified the Assessment of IntraOcular Lens Implant Symptoms (AIOLIS), developed by the American Academy of Ophthalmology (AAO), as a Medical Device Development Tool (MDDT).

This designation empowers medical device sponsors to employ AIOLIS in the clinical assessment of patients' perceptions regarding visual disturbances following premium intraocular lens (IOL) cataract surgery.

Comprehensive Assessment Tool: Understanding AIOLIS

The AIOLIS questionnaire comprises 15 questions each on the frequency and bother of ocular symptoms, alongside inquiries about general vision and the necessity of corrective eyewear. It targets key visual symptoms, including halos, glare, starbursts, and blurry vision, over a recent week. Notably, AIOLIS questions are accompanied by written definitions and visual aids to facilitate precise patient responses.

The development of AIOLIS was a collaborative effort involving the AAO, UCLA, Ron D. Hays, PhD, RAND, and four major IOL device manufacturers: Alcon, Bausch & Lomb, Carl Zeiss Meditec AG, and Johnson & Johnson. The questionnaire underwent extensive field testing by 20 cataract surgeons across various U.S. and international sites.

Clinical Validation: FDA Focus Groups

Moreover, the FDA conducted 13 focus groups involving 93 patients, both pre- and post-cataract surgery, to assess AIOLIS. The results demonstrated a significant reduction in reported symptoms postoperatively. Common preoperative symptoms included glare, blurry vision, starbursts, hazy vision, snowballs, and halos.

Regarding the MDDT assessment, the FDA affirmed the reliability and validity of AIOLIS scores in describing patients' experiences during intraocular lens implant surgery. The observed changes in scores over time and their correlation with other outcomes underscore the utility of AIOLIS within the approved context of use.

The FDA's designation of AIOLIS as an MDDT marks a significant advancement in the evaluation of premium IOL cataract surgery outcomes, promising to enhance patient care and satisfaction within the field of ophthalmology.

References

FDA Approves Assessment Tool to Help Drive Innovation in Premium IOL Cataract Surgery. Press release; May 24, 2024. Accessed May 28, 2024. 

MDDT SUMMARY OF EVIDENCE AND BASIS OF QUALIFICATION DECISION FOR Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) V. 1.0. U230223/S001. https://www.fda.gov/media/178644/download