UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between subjective happines and ocular disorders
Acronym	Relationship between subjective happines and ocular disorders
Scientific Title	Relationship between subjective happines and ocular disorders
Scientific Title:Acronym	Relationship between subjective happines and ocular disorders
Region	Japan

Condition
Condition	Myopia, hyperopia, emmetropia, myopic astigmatism, hyperopic astigmatism, mixed astigmatism, cataract, glaucoma, macular degeneration, diabetic retinopathy, epi retinal membrane, retinal detachment, retinitis pigmentosa, optic neuropathy, corneal opacity, keratoconus, corneal endothelial dysfunction, dry eye, conjunctivitis, Orbital fracture, ptosis, lacrimal duct obstruction
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate relationship between subjective happiness and visual function of the patients with popular ocular disorders
Basic objectives2	Others
Basic objectives -Others	To compare subjective happeniss scale among popular ocular disorders
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective Happiness Scale,
Key secondary outcomes	quality of sleep, visual function

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
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Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who come to out patient clinic and are 20 years old or more.
Key exclusion criteria	Patients who are judged to be inappropriate as a subject due to various reasons, such as the patients can't undergo ocular examinations or reply the questionnaires because of decreased cognitive function.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuno Negishi
Organization	Keio university school of medicine
Division name	Department of ophthalmology
Zip code
Address	Shinanomachi 35, Shinjuku-ku, Tokyo Japan
TEL	81333598302
Email	fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuno Negishi
Organization	Keio university school of medicine
Division name	Department of ophthalmology
Zip code
Address	Shinanomachi 35, Shinjuku-ku, Tokyo Japan
TEL	81333598302
Homepage URL
Email	fwic7788@mb.infoweb.ne.jp.

Sponsor
Institute	Keio university school of medicine
Institute
Department

Funding Source
Organization	Keio university school of medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
Organization
Address
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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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 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	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	cross sectional study. Patients who recieves medical examination at the department of ophthalmology, Keio University Hospital.

Management information
Registered date	2016 Year 01 Month 28 Day
Last modified on	2016 Year 03 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023865

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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