UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020559
Receipt number 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 09:38:27

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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 or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



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

Value
https://center6.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