UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030724
Receipt number R000035079
Scientific Title Evaluation of a novel laser visual aid's potential to improve visual ability of ophthalmic patients
Date of disclosure of the study information 2018/01/08
Last modified on 2018/01/08 12:46:56

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Basic information

Public title

Evaluation of a novel laser visual aid's potential to improve visual ability of ophthalmic patients

Acronym

Evaluation of a novel laser visual aid

Scientific Title

Evaluation of a novel laser visual aid's potential to improve visual ability of ophthalmic patients

Scientific Title:Acronym

Evaluation of a novel laser visual aid

Region

Japan


Condition

Condition

Ophthalmic diseases causing visual impairment in general, including refractive error and ocular media opacity

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A novel retianl imaging laser eyewear (LEW) scans a narrow laser beam on the retina to enable wearers to see focus-free, full-color images. This LEW is expected to be useful as a visual aid for people with vision impairment. The purpose of this exploratory study is to assess the possibility of the LEW to improve visual ability of ophthalmology patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual acuity measured with Landolt's chart before, during, and after the use of LEW

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Single arm
Intervention: the use of LEW
term: several minutes
Control: self control

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with visual impairment due to refractive error or media opacity, with no retrobulbar disorders.
Provision of signed and dated informed consent prior to any study procedures.

Key exclusion criteria

Unwillingness to provide consent to any study procedures
Inability of self-judgement

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Kato

Organization

The University of Tokyo Hospital

Division name

The Department of Ophthalmology

Zip code


Address

Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

katou-s@ka2.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Minami

Organization

The University of Tokyo Hospital

Division name

The Department of Ophthalmology

Zip code


Address

Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Homepage URL


Email

takahiro.minami@gmail.com


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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


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



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 08 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

Enrolling by invitation

Date of protocol fixation

2016 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 08 Day

Last modified on

2018 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035079


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name