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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020559
Receipt No. R000023738
Scientific Title Development of the device for the visual evaluation and improvement
Date of disclosure of the study information 2016/12/05
Last modified on 2020/07/20

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Basic information
Public title Development of the device for the visual evaluation and improvement
Acronym The device for the visual evaluation and improvement
Scientific Title Development of the device for the visual evaluation and improvement
Scientific Title:Acronym The device for the visual evaluation and improvement
Region
Japan

Condition
Condition Eye disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop the device for the evaluation of the visual function , and for the improvement of the visual function in low-vision patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Quality of life (QOL) related to the vision (evaluated by VFQ-25 score)
stability of the preferred retinal locus, visual acuity, reading performance
Key secondary outcomes Relationships between the QOL and the each parameter.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Evaluate of the most usable area in the retina, and do the training to see the object using the area. Evaluation and training would be completed at once. If the patient would like to do it again, then the training would be done several times. And, the potential for the low vision aid would be investigated in this device. Evaluation for this would be completed at once.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Low-vision patients and normal volunteer
Key exclusion criteria Patients that the doctor judged as not suitable for the candidate.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ishiko
Organization Asahikawa Medical University
Division name Medicine and Engineering Combined Research Institute
Zip code
Address 2-1-1-1 Midorigaokahigashi, Asahikawa
TEL 0166-68-2543
Email ishiko@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ishiko
Organization Asahikawa Medical University
Division name Ophthalmology
Zip code
Address 2-1-1-1 Midorigaokahigashi, Asahikawa
TEL 0166-68-2543
Homepage URL
Email ishiko@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 旭川医科大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 05 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 36
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 Terminated
Date of protocol fixation
2016 Year 01 Month 13 Day
Date of IRB
2016 Year 01 Month 26 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2021 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 01 Month 13 Day
Last modified on
2020 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023738

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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