UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044856 |
|---|---|
| Receipt number | R000051237 |
| Scientific Title | Effect of Visual Impairment on Quality of Life by Eye Disease in Japan |
| Date of disclosure of the study information | 2021/07/14 |
| Last modified on | 2021/07/14 10:45:50 |
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Basic information
Public title
Effect of Visual Impairment on Quality of Life by Eye Disease in Japan
Acronym
Effect of Visual Impairment on Quality of Life by Eye Disease in Japan
Scientific Title
Effect of Visual Impairment on Quality of Life by Eye Disease in Japan
Scientific Title:Acronym
Effect of Visual Impairment on Quality of Life by Eye Disease in Japan
Region
| Japan |
Condition
Condition
retinal pigmentosa, age-related macular degeneration, corneal degeneration, severe diabetic retinopathy, glaucoma, cataract, and 50 healthy individuals as controls.
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the Japanese-version of the impact of vision impairment (IVI), a vision-related quality of life (VRQoL) questionnaire and evaluate the impact of VI and ocular pathologies using the Japanese IVI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the impact of vision impairment (IVI)
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Visually impaired patients aged 20 years and older (good visual acuity in one eye is less than 0.5) who visit our ophthalmology clinic.
Key exclusion criteria
Developmental abnormalities, behavioral disorders, and dementia cases that make vision screening difficult
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Saiko |
| Middle name | |
| Last name | Matsumura |
Organization
Toho University School of Medicine
Division name
Department of Ophthalmology
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan
TEL
0337624151
saiko.matsumura@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Saiko |
| Middle name | |
| Last name | Matsumura |
Organization
Toho University School of Medicine
Division name
Department of Ophthalmology
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan
TEL
0337624151
Homepage URL
saiko.matsumura@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Toho University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University School of Medicine
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8540, Japan
Tel
0337624151
saiko.matsumura@med.toho-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 14 | 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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
International Collaborative Research
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2021 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051237
