UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial to determine the short-term influence of cataract surgery on circadian biological rhythm and related health outcomes
Acronym	The CLOCK-IOL Study Cataract Surgery and Circadian Biological Rhythm among Japanese Older People with Cataract in Nara, Kansai Region: Influence of Intra Ocular Lens Implantation
Scientific Title	A randomized controlled trial to determine the short-term influence of cataract surgery on circadian biological rhythm and related health outcomes
Scientific Title:Acronym	The CLOCK-IOL Study Cataract Surgery and Circadian Biological Rhythm among Japanese Older People with Cataract in Nara, Kansai Region: Influence of Intra Ocular Lens Implantation
Region	Japan

Condition
Condition	Cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether cataract surgery modifies the internal biological rhythm and improves its related health outcomes such as depression, sleep quality, body mass regulation and glucose/lipid metabolism at 3 months after surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Depressive sympoms assessed using the short version of geriatric depression scale (GDS-15)
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cataract surgery with implantation of intraocular lens
Interventions/Control_2	Control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)patients scheduled for the first cataract surgery 2)age <=60 years 3)cataract with <=grade 2 nuclear opacification according to LOCS III
Key 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
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Keigo Middle name Last name Saeki
Organization	Nara Medical University School of Medicine
Division name	Department of Community Health and Epidemiology
Zip code	634-8521
Address	840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL	0744-29-8841
Email	saekik@naramed-u.ac.jp

Public contact
Name of contact person	1st name Keigo Middle name Last name Saeki
Organization	Nara Medical University School of Medicine
Division name	Department of Community Health and Epidemiology
Zip code	634-8521
Address	840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL	0744-29-8841
Homepage URL
Email	saekik@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University School of Medicine, Department of Community Health and Epidemiology
Institute
Department

Funding Source
Organization	Nara medical university school of medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Nara Medical University
Address	Shijo-cho 840, Kashihara-shi, Nara
Tel	0744-22-3051
Email	ychiken@naramed-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	奈良県立医科大学付属病院　　　　　　　　　　　 Nara Medical University Hospital

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	169
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 07 Month 15 Day
Date of IRB	2014 Year 03 Month 31 Day
Anticipated trial start date	2014 Year 07 Month 28 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 15 Day
Last modified on	2021 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016916