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FDA qualifies Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) as Medical Device Development Tool

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Article

The AIOLIS will be used to clinically evaluate patients’ perception of visual disturbances following premium IOL cataract surgery.

(Image Credit: AdobeStock/Toowongsa)

(Image Credit: AdobeStock/Toowongsa)

The US Food and Drug Administration (FDA) has qualified the AAO’s patient-reported outcome measure for Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) as a Medical Device Development Tool (MDDT).

According to AAO, this will allow medical device sponsors to use the Academy’s AIOLIS to clinically evaluate patients’ perception of visual disturbances following premium IOL cataract surgery.1

The AIOLIS consists of 15 questions each on the frequency and bother of ocular symptoms, 5 questions about general vision, a question about vision up close, and a question regarding the frequency of wearing glasses or contact lenses, for a total of 37 questions.2

The symptom questions assess the frequency and nuisance of 15 key visual symptoms over the last 7 days.

The key symptoms the questions focus on include:

  • Snowballs
  • Halos
  • Starbursts or streaks
  • Glare during the day and night
  • Light flashes or streaks with eyes open
  • Light flashes with eyes closed
  • Rings and spider webs
  • Hazy vision
  • Blurry vision
  • Distortion in vision
  • Double or multiple images
  • Dark, crescent-shaped shadow or dark line
  • Floaters
  • Flickering or shimmering images

The AAO states that most symptoms are presented to the patient with written definitions and pictures to help patients more accurately identify the visual symptom and more accurately record their response.1

The AIOLIS was developed in a multi-year collaboration among the Academy, UCLA, Ron D Hays, PhD, RAND, and 4 IOL device manufacturers (Alcon, Bausch & Lomb, Carl Zeiss Meditec AG, and Johnson & Johnson). AIOLIS was also field tested by 20 cataract surgeons in sites across the US as well as 2 sites outside of the US.1

Furthermore, the FDA stated 13 focus groups were conducted with 93 patients (87 in English and 6 in Spanish) where the AIOLIS was administered online to adults scheduled for binocular implantation of the same IOL. The survey was completed pre-operatively (n = 716) and postoperatively (n = 554) and showed that 86%-88% of the respondents had only 1 missing answer out of 27 questions asked on both preoperative and postoperative surveys.2

According to the results from the focus groups, the percentage of all symptoms decreased significantly (p <.0001) from before to after surgery, except for dark crescent-shaped shadows, which were uncommon preoperatively and postoperatively (4% at both time points). The most common preoperative symptoms were glare (pre-operative/post-operative 84%/36%), blurry vision (68%/22%), starbursts (66%/28%), hazy vision (63%/18%), snowballs (55%/17%) and halos (52%/22%).2

In regards to the MDDT assessment, the FDA stated“the current evidence demonstrates adequate reliability of the scores to describe the experience of patients undergoing intraocular lens implant surgery” and that “the change of scores across time, and relationships with other outcomes support the validity of the scores within the approved context of use.”

References:
  1. FDA Approves Assessment Tool to Help Drive Innovation in Premium IOL Cataract Surgery. Press release; May 24, 2024. Accessed May 28, 2024. https://www.aao.org/newsroom/news-releases/detail/fda-approves-assessment-tool-to-help-drive-innovat
  2. 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
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