Abstract
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. Questionnaire development and validation study. The Questionnaire for Visual Disturbances (QUVID) was developed based on a literature and instrument review; 13 clinician interviews among ophthalmologists in the United States and Europe; and 67 hybrid qualitative patient interviews among adult patients in the United States and Australia before and/or after monofocal, traditional multifocal, or trifocal IOL implantation. Assessment of the QUVID's psychometric properties was conducted via a noninterventional cross-sectional study of previously treated cataract patients in the United States, 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). The QUVID includes subitems about the bothersomeness of 7 visual symptoms: starburst, halo, glare, hazy vision, blurred vision, double vision, and dark areas. The postoperative version contains 1 item asking the respondents whether their symptoms bothered them enough to want another surgery, if the IOL was the cause. 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.
Highlights
Assessment of the Questionnaire for Visual Disturbances (QUVID)’s psychometric properties was conducted via a noninterventional crosssectional study of previously treated cataract patients in the United States, 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 intraocular lens (IOL) compared with monofocal IOL controls (n = 457)
Premium IOLs can correct for presbyopia in older patients, and certain types of IOLs can correct for astigmatism
Ogy (AAO)–United States Food and Drug Administration (FDA) Task Force on premium IOLs stated that current patient-reported outcome measures (PROMs) did not adequately assess dysphotopsias following cataract surgery with IOL implantation and recommended developing a questionnaire to better measure those outcomes.[9]
Summary
C ataracts are the leading cause of blindness worldwide and one of the most common causes of visual impairment in adults aged 50 years or older.[1]. Newer presbyopia-correcting IOL designs that do not split light have been introduced that are intended to extend the range of vision without increasing the risk for visual disturbances It is, all the more important to ascertain the safety of newer IOLs so that patients could decide on their own preferences for benefits/risks. There is a need to develop PROMs in the IOL space that will provide reliable and valid results to aid in patient decision making and clinician and patient communication The objective of this project was to develop a questionnaire fit for the purpose of assessing patient-relevant visual symptoms before and after cataract surgery and IOL implantation in clinical trials of newer IOLs. This article presents the rigorous development and validation of the Questionnaire for Visual Disturbances (QUVID), a PROM that was developed to assess safety endpoints in clinical trials and could be used clinically to monitor visual symptoms over time. Development of the QUVID was conducted in accordance with the FDA Guidance to Industry on PROMs as well as reports from the ISPOR PRO (International Society for Pharmacoeconomics and Outcomes Research Patient-Reported Outcomes) Good Research Practices Task Force.[7,8,10]
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