UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042833
Receipt number R000048900
Scientific Title Usefulness of aniseikonia test using an eye mark halo
Date of disclosure of the study information 2021/01/05
Last modified on 2023/07/03 09:32:05

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Basic information

Public title

Usefulness of aniseikonia test using an eye mark halo

Acronym

Usefulness of aniseikonia test using an eye mark halo

Scientific Title

Usefulness of aniseikonia test using an eye mark halo

Scientific Title:Acronym

Usefulness of aniseikonia test using an eye mark halo

Region

Japan


Condition

Condition

normal eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examining its usefulness as an evaluation method for aniseikonia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Aniseikonia

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

correct distance visual acuity 0.15 logMAR or better

Key exclusion criteria

patients under 20 years
correct distance visual acuity less than 0.15 logMAR
patients with glaucoma, retinal disease, optic nerve disease, and corneal opacity
Patients judged by physicians to be difficult to examine

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Nobuyuki
Middle name
Last name Shoji

Organization

School of Medicine, Kitasato University

Division name

Department of Ophthalmology

Zip code

2520373

Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan

TEL

042-778-8464

Email

nshoji@kitasato-u.ac.jp


Public contact

Name of contact person

1st name Rie
Middle name
Last name Hoshikawa

Organization

Kitasato University

Division name

School of Allied Health Sciences

Zip code

252-0373

Address

1-15-1, Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan

TEL

042-778-9671

Homepage URL


Email

pink417dj@yahoo.co.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Kitasato University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kitasato University Hospital

Address

1-15-1, Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan

Tel

042-778-8273

Email

rinrib@med.kitasato-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

2021 Year 01 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

60

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

2020 Year 11 Month 01 Day

Date of IRB

2021 Year 01 Month 08 Day

Anticipated trial start date

2021 Year 01 Month 10 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a examination of the effectiveness and usefulness of medical equipment registered in general medical equipment.


Management information

Registered date

2020 Year 12 Month 24 Day

Last modified on

2023 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048900


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name