Understanding the visual function symptoms and associated functional impacts of phakic presbyopia

Abstract

Background Presbyopia is defined as the age-related deterioration in the ability to focus on close objects, causing difficulty with near vision tasks. The study aim was to understand the lived experience of phakic presbyopia and identify all relevant visual function symptoms and associated functional impacts. Methods Fifty individuals with clinician-confirmed phakic presbyopia (US n = 30, France n = 10, Germany n = 10) and seven healthcare professionals (HCPs) participated in in-depth, face-to-face, qualitative concept elicitation interviews. Verbatim transcripts were analyzed using thematic analysis methods. Results Visual function symptoms reported by participants with phakic presbyopia were categorized as: primary near vision functioning symptoms (impaired near visual acuity, n = 50/50, 100%; difficulty with near vision in dim light, n = 42/50, 84%; difficulty focusing at close distances, n = 30/50, 60%; difficulty seeing things when glare is present, n = 30/50, 60%) and secondary symptoms (eye strain, n = 37/50, 74%; dry eyes, n = 35/50, 70%; headaches, n = 30/50, 60%). Proximal impacts on functional vision included difficulty reading in near vision (n = 49/50, 98%, including printed text and handwriting), seeing objects in near vision n = 48/50, 96%, and performing activities of daily living that require near vision (n = 49/50, 98%, including using a smartphone or computer). Distal impacts on functional vision included emotional, work, financial and social impacts. HCP interviews supported participant findings. Conclusion Findings provide a comprehensive understanding of the lived experience of phakic presbyopia which informed the development of a presbyopia conceptual model and patient-reported outcome assessments of vision correction independence and near vision functioning. The sample did not include those whose vision cannot be adequately corrected with lenses or surgery.

Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items

“…Psychometric evaluation of the NAVQ-P and additional PRO instruments has been conducted in line with regulatory best-practice guidelines for development of PRO instruments, adding to the previous qualitative evidence supporting the content validity of the NAVQ-P in phakic presbyopia [ 2 , 3 ].…”

“…Several patient-reported outcome (PRO) instruments have been developed to assess patient-reported near-vision function, however few have been validated as disease specific measures to support efficacy endpoints in presbyopia clinical trials [ 3 – 8 ]. An initial instrument review identified the Near Activity Visual Questionnaire (NAVQ) as a potentially suitable instrument to measure near vision function [ 8 ].…”

“…There are a number of considerations when managing pseudo-phakic presbyopia in comparison to phakic presbyopia such as navigating corneal scars and residual corneal irregularities from prior incisions, increased prevalence of some symptoms such as dry eyes [ 9 ] and differences in visual function such as poorer intermediate vision [ 11 , 12 ]. As a result, research was conducted to modify the NAVQ for it to reflect current use of digital screens and to confirm its content validity in people with phakic presbyopia [ 3 , 4 , 8 ], in line with best practice guidelines for PRO development [ 2 – 8 , 13 – 16 ]. The research was conducted in two phases: phase one; qualitative research to modify and assess the content validity of the NAVQ-P and phase two; psychometric validation of the NAVQ-P.…”

Comparison of Literature Review, Social Media Listening, and Qualitative Interview Research Methods in Generating Patient-Reported Symptom and Functional Impact Concepts of Presbyopia

“…The HCP interviews were conducted via telephone over two rounds and included 30 min of CE [ 29 ]. HCPs were either ophthalmologists or optometrists and were identified based on their expertise and contribution to the research field.…”

“…This involved the review of posts from Twitter, online forums, blogs, and news outlets to supplement the literature review and provide further insight into the lived experience of presbyopia [ 28 ]. Third, qualitative CE interviews with individuals with presbyopia and healthcare professionals (HCPs), who were experienced in treating presbyopia, were conducted to gain a comprehensive understanding of the individual experience of phakic presbyopia (with the natural crystalline lens still intact) and to identify all relevant visual function symptoms and associated functional impacts [ 29 ]. A further aim of the study was to develop a conceptual model based on the findings from the literature review, SML study, and qualitative CE interviews.…”