UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038726 |
|---|---|
| Receipt number | R000044105 |
| Scientific Title | Verification of the night-vision aid (HOYA MW10 HiKARI) in patient with visual field defect |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2023/12/04 11:31:05 |
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Basic information
Public title
Verification of the night-vision aid (HOYA MW10 HiKARI) in patient with visual field defect
Acronym
Verification of the night-vision aid (HOYA MW10 HiKARI)
Scientific Title
Verification of the night-vision aid (HOYA MW10 HiKARI) in patient with visual field defect
Scientific Title:Acronym
Verification of the night-vision aid (HOYA MW10 HiKARI)
Region
| Japan |
Condition
Condition
patient with visual field defect
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect verification of the night-vision aid (HOYA MW10 HiKARI) for visual field in the patient with visual field defect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change in the angle on the visual field test by camera lenses with three different angles of view
Key secondary outcomes
The amount of change in maximum reading speed on the MNREAD-J by camera lenses with three different angles of view
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Rotation of the examination camera lens
Group1: standard-angle lens (27 degrees), middle-angle lens (90 degrees), and wide-angle lens (142 degrees)
Interventions/Control_2
Rotation of the examination camera lens
Group2: middle-angle lens (90 degrees), wide-angle lens (142 degrees), and standard-angle lens (27 degrees)
Interventions/Control_3
Rotation of the examination camera lens
Group3: wide-angle lens (142 degrees), standard-angle lens (27 degrees), and middle-angle lens (90 degrees)
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
| 13 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Best corrected decimal visual acuity higher than (0.1) on the better eye.
2. The central visual field remains
3. Able to come to the hospital in the examination day
4. Obtained informed consent after explanation with the instructions
Key exclusion criteria
1. Unable to visual field test correctly
2. Determined to be inappropriate by the person in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Ikeda |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Ophthalmology
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2806
ymocl@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Mawatari |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Ophthalmology
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2806
Homepage URL
go_mawatari@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, University of Miyazaki
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
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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
| 2020 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044105
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
