July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Development and Qualitative validation of KAMRA Inlay Patient Questionnaire (KIPQ)
Author Affiliations & Notes
  • Srividhya Vilupuru
    Acufocus, Irvine, California, United States
  • Ling Lin
    Acufocus, Irvine, California, United States
  • Corina van de Pol
    Optometry, Marshall B. Ketchum University, Fullerton, California, United States
    Acufocus, Irvine, California, United States
  • Robin L Chalmers
    Clinical Trial Consultant, Atlanta, Georgia, United States
  • Linda Abetz Webb
    Patient-Centered Outcomes Assessments, Cheshire, United Kingdom
  • Footnotes
    Commercial Relationships   Srividhya Vilupuru, Acufocus (E); Ling Lin, AcuFocus (E); Corina van de Pol, AcuFocus (C); Robin Chalmers, AcuFocus (C); Linda Webb, AcuFocus (C)
  • Footnotes
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Investigative Ophthalmology & Visual Science July 2018, Vol.59, 5177. doi:
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      Srividhya Vilupuru, Ling Lin, Corina van de Pol, Robin L Chalmers, Linda Abetz Webb; Development and Qualitative validation of KAMRA Inlay Patient Questionnaire (KIPQ). Invest. Ophthalmol. Vis. Sci. 2018;59(9):5177.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : The purpose of the study was to ensure concept coverage, content validity and understandability of the KIPQ to assess visual symptoms in patients with presbyopia who had been implanted with the KAMRA inlay.

Methods : Twenty-one subjects with the KAMRA inlay were included in the first phase of the study. Subjects had varying education (67% ≥ high school), ethnicity (81% Caucasian), age (48%: 45-55 and 52%: 56 to 60 years), gender (71% female), satisfaction level (52%) and inlay experience (43% ≤ 1 year). Concept elicitation and cognitive debriefing interviews were conducted on the draft KIPQ, which included 16 visual symptoms and 2 satisfaction items. All interviews were transcribed verbatim and the KIPQ was modified and retested iteratively after the analysis of each set of five interviews. Data were analyzed for the total sample, by education level, race and inlay experience. Subjects rated the questionnaire on ease of completion, comprehensibility, acceptability and redundancy on a 1 (e.g., very easy) to 10 (e.g., very hard). Conceptual saturation (no new information arises from the data) was assessed by comparing concepts that arose within each patient set. In the second phase, cognitive debriefing interviews were conducted with 8 prior subjects on modifications made based on the results from the initial phase.

Results : Visual symptoms related to far and near vision under different lighting conditions, night vision (glare, halos, starbursts), dry eye, binocular vision were included. Concept saturation was achieved by the final set of interviews, and resulted in the addition of two symptoms to the KIPQ. Subjects reported that the KIPQ was easy to complete, understand, acceptable and lacked redundancy (rating range of 1-2 for all subjects), though clinical assessment of the interviews suggested some confusion in the interpretation of night vision symptoms. Therefore, photographs from the PROWL questionnaire were added, which enhanced patient understanding of night vision symptoms in the final study phase. There were no major differences between education level, ethnicity, age, satisfaction level and implantation time with any items. The final KIPQ instrument has 18 visual symptom and 2 satisfaction items.

Conclusions : The final KIPQ instrument has achieved content validity and will be implemented in a post-approval study for further assessment in those who will be implanted with the KAMRA inlay.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.


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