title: Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism.
  
  
  METHODS
  We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical activity and wrist skin temperature, and urinary melatonin metabolite. Chronotype and visual function will be assessed using the 'morningness-eveningness' questionnaire, the Munich chronotype questionnaire, and the National Eye Institute Visual Function Questionnaire.
  
  
  CONCLUSIONS
  Although there are potential limitations due to the difference in duration from baseline survey to outcome measurements between two groups, any seasonal effect on the outcome measurement will be balanced as a result of continuous inclusion of participants through the year, and outcomes will be adjusted for day length at outcome measurements at analysis.
  
  
  BACKGROUND
  UMIN000014559, UMIN Clinical Trials Registry, registered on 15 July 2014.
authors.affiliation: Department of Community Health and Epidemiology, Nara Medical University School of Medicine, 840 Shijocho, Kashiharashi, Nara 634-8521, Japan. saekik@naramed-u.ac.jp.
authors.forename: Keigo
authors.initials: K
authors.lastname: Saeki
authors.forename: Kenji
authors.initials: K
authors.lastname: Obayashi
authors.forename: Tomo
authors.initials: T
authors.lastname: Nishi
authors.forename: Kimie
authors.initials: K
authors.lastname: Miyata
authors.forename: Shinji
authors.initials: S
authors.lastname: Maruoka
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Ueda
authors.forename: Masahiro
authors.initials: M
authors.lastname: Okamoto
authors.forename: Taiji
authors.initials: T
authors.lastname: Hasegawa
authors.forename: Toyoaki
authors.initials: T
authors.lastname: Matsuura
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Tone
authors.forename: Nahoko
authors.initials: N
authors.lastname: Ogata
authors.forename: Norio
authors.initials: N
authors.lastname: Kurumatani
mesh_terms: D001835:Body Weight; D002386:Cataract / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002387:Cataract Extraction; D021081:Chronobiology Disorders / Q000175:diagnosis / Q000209:etiology* / Q000503:physiopathology / Q000523:psychology; D002940:Circadian Rhythm; D002985:Clinical Protocols; D003863:Depression / Q000209:etiology / Q000503:physiopathology / Q000523:psychology; D004734:Energy Metabolism; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D012107:Research Design; D012890:Sleep; D020178:Sleep Disorders, Circadian Rhythm / Q000209:etiology / Q000503:physiopathology / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014785:Vision, Ocular