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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040069
Receipt No. R000045692
Scientific Title Measurement of viewing distance, eye position and pupil size using a screening application of the eye information.
Date of disclosure of the study information 2020/05/01
Last modified on 2020/10/06

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Basic information
Public title Measurement of viewing distance, eye position and pupil size using a screening application of the eye information.
Acronym Measurement of viewing distance, eye position and pupil size using a screening application of the eye information.
Scientific Title Measurement of viewing distance, eye position and pupil size using a screening application of the eye information.
Scientific Title:Acronym Measurement of viewing distance, eye position and pupil size using a screening application of the eye information.
Region
Japan

Condition
Condition visual acuity of 0.15 log MAR or better
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the viewing distance, eye position and pupil size of the patient during reading using a screening application of the eye information.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes viewing distance
eye position
pupil size
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
6 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria corrected visual acuity of 0.15 logMAR or better
Key exclusion criteria under 6 years old
corrected visual acuity under 0.15 logMAR
Target sample size 200

Research contact person
Name of lead principal investigator
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 0427789671
Email pink417dj@yahoo.co.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 0427789671
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
2020 Year 05 Month 01 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
2020 Year 03 Month 15 Day
Date of IRB
2020 Year 06 Month 15 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.Changes in visual distance, eye position, and pupil size over time.
2.Comparison of pupil size between a screening application of the eye information and FP-1000.

Management information
Registered date
2020 Year 04 Month 06 Day
Last modified on
2020 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045692

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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