OBJECTIVES : Presbyopia is characterized by deterioration of near-vision eyesight with onset occurring around age 40. This research describes qualitative work conducted to inform the development of patient-reported outcome (PRO) questionnaires to evaluate presbyopia impacts and coping behaviors.

METHODS : Concept elicitation (CE) interviews were conducted with 20 US presbyopic participants to understand the impacts and coping behaviors of the condition. Presbyopia experts aided in informing selection of relevant measurement concepts that were important to patients and construction of draft PROs. The PROs were evaluated through cognitive debriefing (CD) interviews with 20 additional presbyopic participants for interpretability and relevance.

RESULTS : The most frequently reported impacts from CE interviews included difficulty reading small- and normal-sized text in both regular and dimly lit settings. Frequently reported non-reading impacts included difficulty working with small objects, difficulty performing daily chores, taking longer to complete tasks, and feeling older wearing glasses. Coping mechanisms such as wearing glasses, squinting, and holding reading materials farther out were reported. A task-based PRO was developed instructing participants to complete four near-vision paper-based reading tasks (book, newspaper, nutrition label, menu) under standardized settings, and assess their vision-related reading ability and associated satisfaction. A second PRO was developed to evaluate non-reading impacts and coping behaviors. Cognitive debriefing of these PROs supported participants’ interpretation of tasks and items as intended, as well as their relevance. Participant feedback informed minor changes to item wording and response options.

CONCLUSIONS : These PROs have been developed in accordance with regulatory guidance, with input from both patients and clinical experts and evaluate important concepts for patients living with and managing presbyopia. Additionally, the task-based PRO is a novel approach to assessing performance-based reading tests, allowing patients to characterize their experience following the activity. Psychometric testing is ongoing to evaluate the performance of the PROs and inform score interpretation.