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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014559
Receipt No. R000016916
Scientific Title A randomized controlled trial to determine the short-term influence of cataract surgery on circadian biological rhythm and related health outcomes
Date of disclosure of the study information 2014/07/15
Last modified on 2016/07/15

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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
Middle name
Last name Keigo Saeki
Organization Nara Medical University School of Medicine
Division name Department of Community Health and Epidemiology
Zip code
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
Middle name
Last name Keigo Saeki
Organization Nara Medical University School of Medicine
Division name Department of Community Health and Epidemiology
Zip code
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
Address
Tel
Email

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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 28 Day
Last follow-up date
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
2016 Year 07 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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