Development and Validation of a Visual Symptom-Specific Patient-Reported Outcomes Instrument for Adults with Cataract IOL Implants.

Purpose To develop a patient-reported outcome measure for capturing visual and ocular symptoms before and after implantation of intraocular lenses (IOLs) for treatment of cataracts. Design Questionnaire development and validation study. Methods The Questionnaire for Visual Disturbances (QUVID) was developed based on a literature and instrument review; 13 clinician interviews among ophthalmologists in the United States (US) and Europe; and 67 hybrid qualitative patient interviews among adult patients in the US and Australia before and/or after monofocal, traditional multifocal, or trifocal IOL implantation. Assessment of the QUVID's psychometric properties was conducted via a non-interventional cross-sectional study of previously treated cataract patients in the US, Canada, and Australia (n=150), and assessment of ability to detect meaningful change via 2 pivotal US clinical trials among patients with trifocal or extended vision IOL compared with monofocal IOL controls (n=457). Results The QUVID includes sub-items about the bothersomeness of 7 visual symptoms: Starbursts, Halos, Glare, Hazy Vision, Blurred Vision, Double Vision, and Dark Area. The post-operative version contains 1 item asking the respondents whether their symptoms bothered them enough to want another surgery, if the IOL was the cause. Conclusions The QUVID was reviewed by the US Food and Drug Administration and found appropriate as a fit-for-purpose measure, demonstrating requisite evidence for content validity, construct validity, reliability, and ability to detect change.