A randomized controlled trial to determine the short-term influence of cataract surgery on circadian biological rhythm and related health outcomes
Not Applicable
- Conditions
- Cataract
- Registration Number
- JPRN-UMIN000014559
- Lead Sponsor
- ara Medical University School of Medicine, Department of Community Health and Epidemiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 169
Inclusion Criteria
Not provided
Exclusion Criteria
1)severe mental illness and dementia 2)severe corneal opacity 3)glaucoma with visual field deficit of at least MD>14dB (Humphrey Perimeter) 4)vitreous haemorrhage 5)proliferative diabetic retinopathy 6)macular edema 7)age-related macular degeneration 8)patients needing emergent cataract surgery 9)patients needing combined cataract and glaucoma surgery or combined cataract surgery and vitrectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depressive sympoms assessed using the short version of geriatric depression scale (GDS-15)
- Secondary Outcome Measures
Name Time Method 1 Sleep Outcomes 1) Objective sleep quality (measured using actigrapgh) 2) Subjective sleep quality (Pittsburgh Sleep Quality Index :PSQI) 3) Sleepiness (Epworth Sleepiness Scale :ESS) 2 Glucose-lipid metabolism outcomes 1) FPG, HbA1c 2) TG, T-chol. LDL/HDL cholesterol 3) BMI(Body Mass Index), Abdominal circumference 3 Ophthalmic outcomes 1) Visual accuity 2) Subjective visual function (The National Eye Institute Visual Function Questionnaire:NEI VFQ-25) 4 Circadian rhythm outcomes 1)6-sulfatoxymelatonin (aMT6-s) in a morning spot urine sample 2)Circadian activity rhythm (actigraph) 3)Wrist temperature 4)Post Illumination Pupil Response (PIPR) 5)Morningness-Eveningness Questionnaire (MEQ) 6)Munich ChronoType Questionniare