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- Qualitative Development of Patient-Reported Outcome Items to Assess the Visual Impact of Soft Contact Lenses for Myopia Control
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Board # 149
215149
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Alex Nixon, OD, MS, FAAO
Johnson and Johnson Vision
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Vrushali Korde, PhD
Johnson and Johnson Vision
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Jie Xu, PhD
Johnson and Johnson Vision
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Robert Morlock, PhD
PRO-Spectus
PURPOSE
The prevalence of myopia has increased dramatically, and the related long-term complications are a significant global public health concern (Holden et al., 2016). Multifocal soft contact lenses (MFSCLs) have been demonstrated to slow myopia progression in children through randomized controlled trials (Chamberlain et al., 2019; Walline et al., 2020). Beyond myopia control efficacy, a collaborative US-FDA workshop stated the importance of using patient-reported outcomes (PROs) in clinical trials to assess the impact of the myopia control treatment, but noted that there were no appropriate published PRO measures available (Walline et al., 2018). The purpose of this study was to evaluate the comprehension, relevance, usability, and feasibility of a novel PRO measure assessing visual symptoms and their impact in children wearing soft contact lenses for myopia control.
METHODS
Clinician, parent and pediatric patient participants who met study inclusion/exclusion criteria were recruited from clinical sites that fit children with soft contact lenses for myopia control. An experienced interviewer conducted 1-on-1 virtual interviews facilitated by a semi-structured interview guide. Concept elicitation interviews were conducted to identify important concepts, develop items and inform the conceptual framework; cognitive debriefing interviews were used to ensure the relevance, appropriateness, comprehension, and interpretability for the population of interest. Qualitative thematic analysis of verbatim interview transcripts was performed. Findings contributed to the development and modification of PRO items. PRO items measuring visual impact were categorized as visual symptoms, near vision activities, distance vision activities and school related activities.
RESULTS
5 clinicians, 29 parents and 32 pediatric patient participants (age 7-15) were interviewed. Visual symptoms that theoretically could manifest included ghosting, halo, glare, starburst, low light impairment, fluctuating vision, streaks of light, and blur. Clinicians indicated visual symptoms in this population were rare. Parents and pediatric patient participants confirmed visual symptoms were rare and the impact was minimal if they did occur. If symptoms were reported, they were transient and most likely reported during the initial trial period of MFSCL wear and resolved with continued wear.
CONCLUSION
Qualitative input was used to develop a novel PRO measure to assess visual symptoms and their impact in children wearing soft contact lenses for myopia control. The items are relevant and understandable for subjects 7-15 years old. Quantitative PRO data is needed for psychometric validation to assess the measurement properties of the new PRO measure.
The prevalence of myopia has increased dramatically, and the related long-term complications are a significant global public health concern (Holden et al., 2016). Multifocal soft contact lenses (MFSCLs) have been demonstrated to slow myopia progression in children through randomized controlled trials (Chamberlain et al., 2019; Walline et al., 2020). Beyond myopia control efficacy, a collaborative US-FDA workshop stated the importance of using patient-reported outcomes (PROs) in clinical trials to assess the impact of the myopia control treatment, but noted that there were no appropriate published PRO measures available (Walline et al., 2018). The purpose of this study was to evaluate the comprehension, relevance, usability, and feasibility of a novel PRO measure assessing visual symptoms and their impact in children wearing soft contact lenses for myopia control.
METHODS
Clinician, parent and pediatric patient participants who met study inclusion/exclusion criteria were recruited from clinical sites that fit children with soft contact lenses for myopia control. An experienced interviewer conducted 1-on-1 virtual interviews facilitated by a semi-structured interview guide. Concept elicitation interviews were conducted to identify important concepts, develop items and inform the conceptual framework; cognitive debriefing interviews were used to ensure the relevance, appropriateness, comprehension, and interpretability for the population of interest. Qualitative thematic analysis of verbatim interview transcripts was performed. Findings contributed to the development and modification of PRO items. PRO items measuring visual impact were categorized as visual symptoms, near vision activities, distance vision activities and school related activities.
RESULTS
5 clinicians, 29 parents and 32 pediatric patient participants (age 7-15) were interviewed. Visual symptoms that theoretically could manifest included ghosting, halo, glare, starburst, low light impairment, fluctuating vision, streaks of light, and blur. Clinicians indicated visual symptoms in this population were rare. Parents and pediatric patient participants confirmed visual symptoms were rare and the impact was minimal if they did occur. If symptoms were reported, they were transient and most likely reported during the initial trial period of MFSCL wear and resolved with continued wear.
CONCLUSION
Qualitative input was used to develop a novel PRO measure to assess visual symptoms and their impact in children wearing soft contact lenses for myopia control. The items are relevant and understandable for subjects 7-15 years old. Quantitative PRO data is needed for psychometric validation to assess the measurement properties of the new PRO measure.
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