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  • Disease-specific assessment of Vision Impairment in Low Luminance in age-related macular degeneration – a MACUSTAR study report

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Clinical science
Disease-specific assessment of Vision Impairment in Low Luminance in age-related macular degeneration – a MACUSTAR study report
  1. Jan Henrik Terheyden1,
  2. Susanne G Pondorfer1,
  3. Charlotte Behning2,
  4. Moritz Berger3,
  5. Jill Carlton4,
  6. Donna Rowen4,
  7. Christine Bouchet5,
  8. Stephen Poor5,
  9. Ulrich F O Luhmann6,
  10. Sergio Leal7,
  11. Frank G Holz1,
  12. Thomas Butt8,
  13. John E Brazier4,
  14. Robert P Finger1
  15. the MACUSTAR consortium
    1. 1 Department of Ophthalmology, University Hospital Bonn, Bonn, Germany
    2. 2 Department of Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany
    3. 3 Department of Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany
    4. 4 School of Health and Related Research, University of Sheffield, Sheffield, UK
    5. 5 Novartis Pharma AG, Basel, Switzerland
    6. 6 Roche Pharmaceutical Research and Early Development, Translational Medicine Ophthalmology, Roche Innovation Center Basel, Basel, Switzerland
    7. 7 Bayer AG, Berlin, Germany
    8. 8 UCL Institute of Ophthalmology, University College London, London, UK
    1. Correspondence to Professor Robert P Finger, Department of Ophthalmology, University Hospital Bonn, Bonn, Germany; Robert.Finger{at}ukbonn.de

    Abstract

    Background/aims To further validate the Vision Impairment in Low Luminance (VILL) questionnaire, which captures visual functioning and vision-related quality of life (VRQoL) under low luminance, low-contrast conditions relevant to age-related macular degeneration (AMD).

    Methods The VILL was translated from German into English (UK), Danish, Dutch, French, Italian and Portuguese. Rasch analysis was used to assess psychometric characteristics of 716 participants (65% female, mean age 72±7 years, 82% intermediate AMD) from the baseline visit of the MACUSTAR study. In a subset of participants (n=301), test–retest reliability (intraclass correlation coefficient (ICC) and coefficient of repeatability (CoR)) and construct validity were assessed.

    Results Four items were removed from the VILL with 37 items due to misfit. The resulting Vision Impairment in Low Luminance with 33 items (VILL-33) has three subscales with no disordered thresholds and no misfitting items. No differential item functioning and no multidimensionality were observed. Person reliability and person separation index were 0.91 and 3.27 for the Vision Impairment in Low Luminance Reading Subscale (VILL-R), 0.87 and 2.58 for the Vision Impairment in Low Luminance Mobility Subscale (VILL-M), and 0.78 and 1.90 for the Vision Impairment in Low Luminance Emotional Subscale (VILL-E). ICC and CoR were 0.92 and 1.9 for VILL-R, 0.93 and 1.8 for VILL-M and 0.82 and 5.0 for VILL-E. Reported VRQoL decreased with advanced AMD stage (p<0.0001) and was lower in the intermediate AMD group than in the no AMD group (p≤0.0053).

    Conclusion The VILL is a psychometrically sound patient-reported outcome instrument, and the results further support its reliability and validity across all AMD stages. We recommend the shortened version of the questionnaire with three subscales (VILL-33) for future use.

    Trial registration number NCT03349801.

    • Diagnostic tests/Investigation
    • Macula

    Data availability statement

    Data are available upon reasonable request. The datasets used in the present study are available from the MACUSTAR consortium upon reasonable request.

    https://creativecommons.org/licenses/by/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    https://doi.org/10.1136/bjophthalmol-2021-320848

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      Data availability statement

      Data are available upon reasonable request. The datasets used in the present study are available from the MACUSTAR consortium upon reasonable request.

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      Footnotes

      • Collaborators MACUSTAR Consortium: H Agostini, L Altay, R Atia, F Bandello, P G Basile, C Behning, M Belmouhand, M Berger, A Binns, C J F Boon, M Böttger, C Bouchet, J E Brazier, T Butt, C Carapezzi, J Carlton, A Carneiro, A Charil, R Coimbra, M Cozzi, D P Crabb, J Cunha-Vaz, C Dahlke, L de Sisternes, H Dunbar, R P Finger, E Fletcher, H Floyd, C Francisco, M Gutfleisch, R Hogg, F G Holz, C B Hoyng, A Kilani, J Krätzschmar, L Kühlewein, M Larsen, S Leal, Y T E Lechanteur, U F O Luhmann, A Lüning, I Marques, C Martinho, G Montesano, Z Mulyukov, M Paques, B Parodi, M Parravano, S Penas, T Peters, T Peto, M Pfau, S Poor, S Priglinger, D Rowen, G S Rubin, J Sahel, D Sanches Fernandes, C Sánchez, O Sander, M Saßmannshausen, M Schmid, S Schmitz-Valckenberg, H Schrinner-Fenske, J Siedlecki, R Silva, A Skelly, E Souied, G Staurenghi, L Stöhr, D Tavares, J Tavares, D J Taylor, J H Terheyden, S Thiele, A Tufail, M Varano, L Vieweg, J Werner, L Wintergerst, A Wolf, N Zakaria.

      • Contributors JHT, SGP, CBe, SP, UFOL, SL, FGH and RPF designed the study. JHT, SGP, CB, MB, JC, DR, TB, JB and RPF interpreted the data. JHT, SGP, JC, DR and RPF drafted the manuscript and all authors. CBe, MB, CBo, SP, UFOL, SL, FGH, TB and JB critically revised the manuscript for important intellectual content. All authors approved the final version of the manuscript to be published and agreed to be accountable for all aspects of the work. JHT and RPF are the guarantors.

      • Funding This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking (grant agreement number 116076). This joint undertaking received support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

      • Disclaimer The communication reflects the author's view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.

      • Competing interests JHT: Heidelberg Engineering, Optos, Carl Zeiss Meditec, CenterVueSGP: Heidelberg Engineering, Optos Carl Zeiss Meditec, CenterVue; CBe: None; MB: None; JC: None; DR: None; CBo: employee of Novartis; SP: employee of Novartis; UFOL: employee of F. Hoffmann-La Roche; SL: employee of Bayer; FGH: Acucela, Allergan, Apellis, Bayer, Boehringer-Ingelheim, Bioeq/Formycon, CenterVue, Ellex, Roche/Genentech, Geuder, Grayburg Vision, Heidelberg Engineering, Kanghong, LinBioscience, NightStarX, Novartis, Optos, Pixium Vision, Oxurion, Stealth BioTherapeutics, Zeiss; TB: None; JB: None; RPF: Bayer, Ellex, Novartis, Novartis, Opthea, Alimera, Santhera, Roche/Genentech, CentreVue, Zeiss.

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

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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