UMIN-CTR Clinical Trial

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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