The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study)
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 canc...
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BMJ Publishing Group
2015-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/5/5/e007930.full |
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| author | Taiji Hasegawa Kenji Obayashi Kimie Miyata Tetsuo Ueda Norio Kurumatani Keigo Saeki Nahoko Ogata Hiroki Tsujinaka Mariko Yamashita Tomo Nishi Nobuhiro Tone Naonori Masuda Yutarou Mizusawa Masahiro Okamoto Shinji Maruoka Masashi Kojima Toyoaki Matsuura |
| author_facet | Taiji Hasegawa Kenji Obayashi Kimie Miyata Tetsuo Ueda Norio Kurumatani Keigo Saeki Nahoko Ogata Hiroki Tsujinaka Mariko Yamashita Tomo Nishi Nobuhiro Tone Naonori Masuda Yutarou Mizusawa Masahiro Okamoto Shinji Maruoka Masashi Kojima Toyoaki Matsuura |
| author_sort | Taiji Hasegawa |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-6c02854afaac438faae180f97a92ecbb |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2015-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-6c02854afaac438faae180f97a92ecbb2025-02-09T10:30:09ZengBMJ Publishing GroupBMJ Open2044-60552015-05-015510.1136/bmjopen-2015-007930The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study)Taiji Hasegawa0Kenji Obayashi1Kimie Miyata2Tetsuo Ueda3Norio Kurumatani4Keigo Saeki5Nahoko Ogata6Hiroki Tsujinaka7Mariko Yamashita8Tomo Nishi9Nobuhiro Tone10Naonori Masuda11Yutarou Mizusawa12Masahiro Okamoto13Shinji Maruoka14Masashi Kojima15Toyoaki Matsuura161Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan2Department of Community Health and Epidemiology, Nara Medical University School of Medicine, Nara, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan2Department of Community Health and Epidemiology, Nara Medical University School of Medicine, Nara, Japan2Department of Community Health and Epidemiology, Nara Medical University School of Medicine, Nara, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, JapanDepartment of Ophthalmology, Nara Medical University Graduate School of Medicine, Kashihara, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, JapanJapan Clinical Retina Study (JCREST) group, Kagoshima, Kagoshima, Japan3Center for Academic Industrial and Governmental Relations, Nara Medical University School of Medicine, Nara, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan5 Research and Development Department, AYUMI Pharmaceutical Corporation, Chuo-ku, Tokyo, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan1Department of Ophthalmology, Nara Medical University School of Medicine, Nara, JapanIntroduction 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.https://bmjopen.bmj.com/content/5/5/e007930.full |
| spellingShingle | Taiji Hasegawa Kenji Obayashi Kimie Miyata Tetsuo Ueda Norio Kurumatani Keigo Saeki Nahoko Ogata Hiroki Tsujinaka Mariko Yamashita Tomo Nishi Nobuhiro Tone Naonori Masuda Yutarou Mizusawa Masahiro Okamoto Shinji Maruoka Masashi Kojima Toyoaki Matsuura The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study) BMJ Open |
| title | The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study) |
| title_full | The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study) |
| title_fullStr | The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study) |
| title_full_unstemmed | The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study) |
| title_short | The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study) |
| title_sort | effect of blue blocking intraocular lenses on circadian biological rhythm protocol for a randomised controlled trial clock iol colour study |
| url | https://bmjopen.bmj.com/content/5/5/e007930.full |
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