UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000023738