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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014680
Receipt No. R000017070
Scientific Title A randomized controlled trial to determine the long-term influence of clear intra ocular lens (IOL) and yellow IOL with cataract surgery on circadian biological rhythm and related health outcomes
Date of disclosure of the study information 2014/07/28
Last modified on 2014/07/29

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Basic information
Public title A randomized controlled trial to determine
the long-term influence of clear intra ocular lens (IOL) and yellow IOL with cataract surgery on circadian biological rhythm and related health outcomes
Acronym The CLOCK-IOL Color 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 long-term influence of clear intra ocular lens (IOL) and yellow IOL with cataract surgery on circadian biological rhythm and related health outcomes
Scientific Title:Acronym The CLOCK-IOL Color 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 The purpose of this study is to determine whether cataract surgery with clear IOL improve circadian rhythm misalignment and decrease incidence or mortality rate of its related diseases such as sleep disturbance, depression, obesity, dyslipidemia, diabetes, cancer, stroke, and ischemic heart disease, and age related macular degeneration compared with cataract surgery with yellow IOL.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes All-cause mortality rate
Incidence rate of age related macular degeneration
Key secondary outcomes 1 Frequency of Diseases
1) Prevalence of depression insomnia obesity dyslipidemia and diabetes
2) Incidence rate of cancer, stroke and ischemic heart disease

2 Ophthalmic outcomes
1) Retinal and Choroidal thickness(OCT: optical coherence tomography)
2) Macular pigment density
3) Aberrations(spherical and coma)
4) Contrast sensitivity
5) Accommodation
6) Subjective visual function (The National Eye Institute Visual Function Questionnaire: NEI VFQ-25)
7) Post Illumination Pupil Response (PIPR)

3 Glucose-lipid metabolism outcomes
1) FPG HbA1c
2) TG T-chol LDL chol and HDL chol BMI(Body Mass Index) Abdominal circumference

4 Depression Sleep Outcomes
1) Depressive symptoms
(Geriatric Depression Scale:GDS)
2) Objective sleep quality(measured using actigrapgh)
3) Subjective sleep quality(Pittsburgh Sleep Quality Index:PSQI)
4) Sleepiness(Epworth Sleepiness Scale:ESS)

5 Circadian rhythm outcomes
1) 6-sulfatoxymelatonin(aMT6-s)in a morning spot urine sample
2) Circadian activity rhythm(actigraph)
3) Distal- proximal gradient of skin temperatures (wrist-abdominal)
4) Morningness-Eveningness Questionnaire (MEQ)
5) Munich ChronoType Questionniare


In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
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
Device,equipment
Interventions/Control_1 Yellow IOL group
Phacoemulsification and yellow IOL implantation(SN60AT,SN60WF(Alcon)).
Interventions/Control_2 Clear IOL group
Phacoemulsification and clear IOL implantation (SA60AT(Alcon)).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Nahoko Ogata
Organization Nara Medical University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL 0744-29-8884
Email ogata@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomo Nishi
Organization Nara Medical University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL 0744-29-8884
Homepage URL
Email tomon@naramed-u.ac.jp

Sponsor
Institute Department of Ophthalmology
Nara Medical University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 28 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 28 Day
Last modified on
2014 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017070


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