UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021945 |
|---|---|
| Receipt number | R000025311 |
| Scientific Title | Development and evaluation of the visual aid using see-through head-mount display for visually impaired persons |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2019/04/30 08:34:49 |
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Basic information
Public title
Development and evaluation of the visual aid using see-through head-mount display for visually impaired persons
Acronym
Development and evaluation of the visual aid using see-through head-mount display
Scientific Title
Development and evaluation of the visual aid using see-through head-mount display for visually impaired persons
Scientific Title:Acronym
Development and evaluation of the visual aid using see-through head-mount display
Region
| Japan |
Condition
Condition
retinitis pigmentosa, diabetic retinopathy, glaucoma, etc.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a wearable visual aid utilizing a see-through display for visually impaired persons
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time required to walk the course and the number of contacts with obstacles are assessed as outcomes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To use a wearable visual aid utilizing a see-through display
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
1. visually impaired patients at Kyushu University Hospital or volunteers
2. persons who are able to come to Kyushu University Hospital
3. persons whose agreement was shown by him/herself
Key exclusion criteria
inappropriate case judged by investigator or subinvestigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Ikeda |
Organization
kyushu University Hospital
Division name
Department of Ophthalmology
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5648
ymocl@pathol1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Ikeda |
Organization
kyushu University Hospital
Division name
Department of Ophthalmology
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5648
Homepage URL
ymocl@pathol1.med.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
HOYA CORPORATION
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
Kyushu University Institutional Review Board for Clinical Trials
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
| 2016 | Year | 05 | 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
28
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025311
