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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042833
Receipt No. 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 2020/12/24

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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
Institute Kitasato University
Institute
Department

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
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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 01 Day
Date of IRB
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
2020 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.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


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