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Patient-reported outcome measures in presbyopia: a literature review
  1. Garima Sharma1,
  2. Sima Chiva-Razavi2,
  3. Daniel Viriato2,
  4. Christel Naujoks2,
  5. Francesco Patalano2,
  6. Sarah Bentley3,
  7. Amy Findley3,
  8. Chloe Johnson3,
  9. Rob Arbuckle3,
  10. James Wolffsohn4
  1. 1Novartis Healthcare, Hyderabad, India
  2. 2Novartis Pharma AG, Basel, Switzerland
  3. 3Adelphi Values Patient-Centered Outcomes, Bollington, UK
  4. 4Optometry, Aston University, Birmingham, UK
  1. Correspondence to Ms Sima Chiva-Razavi; sima.chiva-razavi{at}novartis.com

Abstract

Presbyopia is the age-related loss of near-distance focusing ability. The aim of this study was to identify patient-reported outcome measures (PROMs) used in clinical trials and quality-of-life studies conducted in individuals with presbyopia and to assess their suitability for use in individuals with phakic presbyopia. Literature searches were performed in Medline and Embase up until October 2017. Specific search terms were used to identify presbyopia studies that included a PROM. All clinical trials with PROM-supported endpoints in presbyopia were identified on ClinicalTrials.gov. Further searches were conducted to retrieve articles documenting the development and psychometric evaluation of the PROMs identified. A total of 703 records were identified; 120 were selected for full-text review. Twenty-one clinical trials employed PROMs to support a primary or secondary endpoint. In total, 13 PROMs were identified; a further 23 publications pertaining to the development and validation of these measures were retrieved. Most PROMs were developed prior to release of the Food and Drug Administration (FDA) 2009 patient-reported outcome guidance and did not satisfy regulatory standards. The Near Activity Visual Questionnaire (NAVQ) was identified as the most appropriate for assessing near-vision functioning in presbyopia. While the NAVQ was developed in line with the FDA guidance, the items do not reflect changes in technology that have occurred since the questionnaire was developed in 2008 (eg, the increase in smartphone use), and the measure was not validated in a purely phakic presbyopia sample. Further research is ongoing to refine the NAVQ to support trial endpoints related to changes in near-vision functioning associated with phakic presbyopia.

  • eye (globe)
  • field of vision
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Footnotes

  • Contributors GS performed the initial literature search and analysis of data in April 2017. CN did the reanalysis and reporting. SB, AF, CJ and RA did the update of the literature search, along with analysis and reporting, and contributed to critical analysis of NAVQ. DV had the idea of this study. SC-R took over DV's role as the guarantor. FP helped with planning the publication. JW actively collaborated with Novartis to provide all available evidence for NAVQ and permission to use copy of the NAVQ in the manuscript.

  • Funding This study was funded by Novartis Pharma, Basel, Switzerland.

  • Competing interests GS is an employee of Novartis Pharma. SC-R, DV, CN and FP are employees and shareholders of Novartis Pharma. SB, AF and RA are employees of Adelphi Values, which received funding from Novartis to conduct some aspects of the study. CJ was an employee of Adelphi Values during the conduct of this study. While JW was one of the developers of the NAVQ, he did not influence the conclusions and outcome of this review.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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