UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054389 |
|---|---|
| Receipt number | R000062128 |
| Scientific Title | Low Vision Conseling Effectiveness Study |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/11/08 10:05:55 |
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Basic information
Public title
Research on Counseling Effectiveness for Low Vision Care
Acronym
Low Vision Counseling Effectiveness Study
Scientific Title
Low Vision Conseling Effectiveness Study
Scientific Title:Acronym
Low Vision Conseling Effectiveness Study
Region
| Japan |
Condition
Condition
Visually impaired persons requiring low vision care
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a system within the hospital to connect visually impaired patients who need low vision care, or visually impaired patients who visit the outpatient ophthalmology clinic at Keio University Hospital, to support outside the hospital when medical personnel determine that low vision care is necessary.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre- and Post-Counseling Low Vision Care for the Visually Impaired Assessed by the Wong-Baker FACES Foundation Scale
Key secondary outcomes
Differences in primary endpoints by gender
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
| 3 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Visually impaired patients who need low vision care, or visually impaired patients who visit the outpatient ophthalmology clinic at Keio University Hospital, who are judged to need low vision care by medical personnel, and who are able to visit the Keio University Hospital Ophthalmology Clinic during the study period.
Key exclusion criteria
A person who is not judged by the health care provider to need low vision
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | Toshiihide |
| Middle name | |
| Last name | Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
https://eye-keio.jp/specialty/clinical-research.php
kurihara@z8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://eye-keio.jp/specialty/clinical-research.php
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
| 2024 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2024 | Year | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062128
