UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040069 |
|---|---|
| Receipt number | 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 | 2025/04/10 09:43:03 |
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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
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
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
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
Completed
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
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045692
