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The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study)
  1. Tomo Nishi1,
  2. Keigo Saeki2,
  3. Kenji Obayashi2,
  4. Kimie Miyata1,
  5. Nobuhiro Tone3,
  6. Hiroki Tsujinaka1,
  7. Mariko Yamashita1,
  8. Naonori Masuda1,
  9. Yutarou Mizusawa1,
  10. Masahiro Okamoto1,
  11. Taiji Hasegawa1,
  12. Shinji Maruoka1,
  13. Tetsuo Ueda1,
  14. Masashi Kojima1,
  15. Toyoaki Matsuura1,
  16. Norio Kurumatani2,
  17. Nahoko Ogata1
  1. 1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan
  2. 2Department of Community Health and Epidemiology, Nara Medical University School of Medicine, Nara, Japan
  3. 3Center for Academic Industrial and Governmental Relations, Nara Medical University School of Medicine, Nara, Japan
  1. Correspondence to Dr Keigo Saeki; saekik{at}naramed-u.ac.jp

Abstract

Introduction Blue light information plays an important role in synchronising internal biological rhythm within the external environment. Circadian misalignment is associated with the increased risk of sleep disturbance, obesity, diabetes mellitus, depression, ischaemic heart disease, stroke and cancer. Meanwhile, blue light causes photochemical damage to the retina, and may be associated with age-related macular degeneration (AMD). At present, clear intraocular lenses (IOLs) and blue-blocking IOLs are both widely used for cataract surgery; there is currently a lack of randomised controlled trials to determine whether clear or blue-blocking IOLs should be used.

Methods and analysis This randomised controlled trial will recruit 1000 cataract patients and randomly allocate them to receive clear IOLs or blue-blocking IOLs in a ratio of 1:1. The primary outcomes are mortality and the incidence of cardiovascular disease, cancer and AMD. Secondary outcomes are fasting plasma glucose, triglycerides, cholesterol, glycated haemoglobin, sleep quality, daytime sleepiness depressive symptoms, light sensitivity, the circadian rhythm of physical activity, wrist skin temperature and urinary melatonin metabolite. Primary outcomes will be followed until 20 years after surgery, and secondary outcomes will be assessed at baseline and 1 year after surgery.

Ethics and dissemination Ethical approval has been obtained from the Institutional Review Board of Nara Medical University (No. 13-032). The findings of this study will be communicated to healthcare professionals, participants and the public through peer-reviewed publications, scientific conferences and the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) home page.

Trial registration number UMIN000014680.

  • ONCOLOGY

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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