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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027299
Receipt No. R000026049
Scientific Title Influence of glaucoma on circadian biological rhythm
Date of disclosure of the study information 2017/05/11
Last modified on 2017/05/11

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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
Middle name
Last name Tadanobu Yoshikawa
Organization Nara Medical University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL 0744-22-3051
Email yoshikat@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadanobu Yoshikawa
Organization Nara Medical University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 840 Shijo-cho, Kashiharashi, Nara, Japan, 634-8521
TEL 0744-22-3051
Homepage URL
Email yoshikat@naramed-u.ac.jp

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

Funding Source
Organization Novartis Pharma
Mitsui Sumitomo Insurance Foundation
Osakagasgroup welfare 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
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
2017 Year 05 Month 11 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
2017 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 11 Day
Last follow-up date
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
2017 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026049

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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