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Abstract
BackgroundPresbyopia is the age-related deterioration in the ability to focus on close objects. In order to develop a patient-reported outcome (PRO) instrument to assess near vision functioning, the Near Activity Visual Questionnaire (NAVQ) was adapted to incorporate modern technology (e.g. smartphones) and to be appropriate for use in phakic presbyopia, leading to the development of the NAVQ-Presbyopia (NAVQ-P). Additional single-item instruments of near vision correction independence (NVCI), correction preference (NVCP), and vision satisfaction (NVS) were also developed. The study aimed to evaluate the content validity of the NAVQ-P and additional instruments in individuals with phakic presbyopia.MethodsParticipants in the US (n = 15), Germany (n = 10) and France (n = 10) took part in face-to-face, qualitative, cognitive debriefing interviews. Seven healthcare professionals (HCPs) were also interviewed to assess the clinical relevance of the PRO instruments. Interviews started with open-ended qualitative concept elicitation questioning; participants then completed the PRO instruments on an electronic tablet using a “think-aloud” process and were asked about their understanding and relevance of each item, instruction, response scale and recall period. Interviews were conducted in two rounds allowing for modifications between rounds.ResultsThe participants interpreted the majority of the PRO instruments and recall period correctly and consistently. They were able to select an appropriate response option without difficulty. Minor modifications were made to the PRO instruments based on interview findings. Instruction/item wording was modified to include reference to use of a magnifying glass, in addition to glasses and contact lenses. Two items were added to assess difficulty with precision tasks (e.g. sewing) and taking longer to adjust from distance to near vision. HCPs confirmed the relevance of the concepts being measured for presbyopia and recommended the addition of an item assessing contrast sensitivity.ConclusionsDeveloped in accordance with the FDA PRO Guidance, the findings support content validity of the NAVQ-P as a suitable, well-understood instrument of relevant near vision functioning concepts in individuals with phakic presbyopia. The NVCI and additional PRO instruments are appropriate to assess near vision correction independence, correction preference, and vision satisfaction. Future work will assess the psychometric properties of the NAVQ-P and additional PRO instruments.
Highlights
Presbyopia occurs when the physiologically normal agerelated reduction in the eye’s focusing range reaches a point, when optimally corrected for distance vision, that the clarity of vision at near is insufficient to satisfy an individual’s requirements [1, 2]
The near vision correction independence (NVCI) and additional patient-reported outcome (PRO) instruments are appropriate to assess near vision correction inde‐ pendence, correction preference, and vision satisfaction
Future work will assess the psychometric properties of the Near Activity Visual Questionnaire (NAVQ)-P and additional PRO instruments
Summary
Presbyopia occurs when the physiologically normal agerelated reduction in the eye’s focusing range reaches a point, when optimally corrected for distance vision, that the clarity of vision at near is insufficient to satisfy an individual’s requirements [1, 2]. It is hypothesized to be caused by a loss of lens elasticity preventing focal point change [3, 4]. Individuals with presbyopia have difficulty with near vision function tasks (e.g. reading or threading a needle [7, 8]) and experience burden associated with wearing glasses [9]. Presbyopia is the age-related deterioration in the ability to focus on close objects. The study aimed to evaluate the content validity of the NAVQ-P and additional instruments in individuals with phakic presbyopia
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