UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027299 |
|---|---|
| Receipt number | R000026049 |
| Scientific Title | Influence of glaucoma on circadian biological rhythm |
| Date of disclosure of the study information | 2017/05/11 |
| Last modified on | 2023/11/14 19:25:33 |
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Basic information
Public title
Influence of glaucoma on circadian biological rhythm
Acronym
Influence of glaucoma on circadian biological rhythm
Scientific Title
Influence of glaucoma on circadian biological rhythm
Scientific Title:Acronym
Influence of glaucoma on circadian biological rhythm
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether glaucoma affect circadian biological rhythm
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of circadian rhythm-related disorder (depressive symptoms, sleep disturbance and cognitive impairment)
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) Cognitive function (Mini Mental State Examination: MMSE)
Key secondary outcomes
1 Ophthalmic outcomes
1) Visual acuity and intraocular pressure
2) Retinal and Choroidal thickness(OCT: optical coherence tomography)
3) OCT angiography
4) Visual field
5) ocular circulation (LSFG: Laser Speckle Flowgraphy)
6) Post Illumination Pupil Response (PIPR)
7) Contact Dermatitis
8) The 25-itemNational Eye Institute Visual Function Questionnaire (NEI VFQ-25)
2 Glucose-lipid metabolism outcomes
1) FPG HbA1c
2) TG T-chol LDL chol and HDL chol BMI(Body Mass Index) Abdominal circumference
3 Circadian rhythm outcomes
1) 6-sulfatoxymelatonin(aMT6-s)in a morning spot urine sample
2) Circadian activity rhythm
3) skin temperatures
4) ambulatory blood pressure monitoring (ABPM)
4 Vascular endothelial function
Asymmetric Dimethylarginine (ADMA)
5 Neurotrophic factor
Brain-derived neurotrophic factor (BDNF)
6 Residential characteristics
7 Dietary habit
8 Physical activity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients meets glaucoma criteria for Taijimi study.
Key exclusion criteria
1)severe mental illness and dementia
2)severe corneal opacity and cataract
3)vitreous hemorrhage
4)severe retinal and choroidal disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tadanobu |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nara Medical University School of Medicine
Division name
Department of Ophthalmology
Zip code
634-8521
Address
840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL
0744-22-3051
yoshikat@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadanobu |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nara Medical University School of Medicine
Division name
Department of Ophthalmology
Zip code
634-8521
Address
840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL
0744-22-3051
Homepage URL
yoshikat@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University School of Medicine, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma, Mitsui Sumitomo Insurance Foundation, Osakagasgroup welfare foundation, KAKENHI, The Osaka community Foundation, Setsuro Fujii Memorial-the Osaka Foundation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University School of Medicine
Address
840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
Tel
0744-22-3051
kenkyu@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
| 2017 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
172
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2017 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026049
