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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000020776 |
Receipt No. | R000023865 |
Scientific Title | Relationship between subjective happines and ocular disorders |
Date of disclosure of the study information | 2016/02/01 |
Last modified on | 2016/03/28 |
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 |
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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 |
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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 | |
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 |
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Age-upper limit |
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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 |
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Organization | Keio university school of medicine | ||||||
Division name | Department of ophthalmology | ||||||
Zip code | |||||||
Address | Shinanomachi 35, Shinjuku-ku, Tokyo Japan | ||||||
TEL | 81333598302 | ||||||
fwic7788@mb.infoweb.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | Keio university school of medicine | ||||||
Division name | Department of ophthalmology | ||||||
Zip code | |||||||
Address | Shinanomachi 35, Shinjuku-ku, Tokyo Japan | ||||||
TEL | 81333598302 | ||||||
Homepage URL | |||||||
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 | |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |