UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014680 |
|---|---|
| Receipt number | 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 12:37:25 |
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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
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
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
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
tomon@naramed-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology
Nara Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017070
