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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038726
Receipt No. 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 2021/05/31

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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 number of viewpoints on the Humphrey visual field analyzer 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
Email 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
Email go_mawatari@med.miyazaki-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Faculty of Medicine, University of Miyazaki
Institute
Department

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
Email 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 Open public 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
2022 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
2021 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044105

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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