UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055167 |
|---|---|
| Receipt number | R000063037 |
| Scientific Title | Verification of factors preventing the onset of "esotropia associated smartphone" using eye movement analysis during smartphone viewing |
| Date of disclosure of the study information | 2024/08/10 |
| Last modified on | 2025/08/06 09:46:21 |
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Basic information
Public title
Verification of factors preventing the onset of "esotropia associated smartphone" using eye movement analysis during smartphone viewing
Acronym
Verification of factors preventing the onset of "esotropia associated smartphone" using eye movement analysis during smartphone viewing
Scientific Title
Verification of factors preventing the onset of "esotropia associated smartphone" using eye movement analysis during smartphone viewing
Scientific Title:Acronym
Verification of factors preventing the onset of "esotropia associated smartphone" using eye movement analysis during smartphone viewing
Region
| Japan |
Condition
Condition
normal subject
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects on eye position with and without the reset task of visual input during smartphone viewing, and comparing the presence or absence of background factors such as individual refraction error, stereopsis, and eye movement characteristics during smartphone viewing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ocular deviation angle at far (5m)
Key secondary outcomes
ocular deviation angle at near (30cm), refraction error (binocular, monocular), accommodative function, near stereopsis, far stereopsis, presence of diplopia, number of blinks during viewing smartphone, number of saccades during viewing smartphone, range of gaze fixation during viewing smartphone, pupil diameter during viewing smartphone, distance between smartphone and eye during viewing smartphone, CVS-Q score, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Voluntary blinks every 2 minutes during viewing smartphone
Interventions/Control_2
Far-sighted saccades every 2 minutes during viewing smartphone
Interventions/Control_3
No intervention
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy individuals between the ages of 18 and 30 who have given consent to participate in the study
(2) No manifest strabismus
(3) Corrected visual acuity of 1.0 or better in both eyes
(4) Normal stereopsis (near stereopsis of 60 seconds or less)
(5) No history of amblyopia.
Key exclusion criteria
(1) Not wish to participate in this study
(2) A history of central nervous system disease or systemic disease that may affect eye position or eye movement
(3) unable to use a smartphone for more than 30 minutes continuously
(4) Determined to be inappropriate by the researcher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Miharu |
| Middle name | |
| Last name | Mihara |
Organization
University of Toyama
Division name
Ophthalmology
Zip code
9300194
Address
2630 Sugitani, Toyama, Toyama
TEL
+81-76-434-7363
miharu@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Miharu |
| Middle name | |
| Last name | Mihara |
Organization
University of Toyama
Division name
Ophthalmology
Zip code
9300194
Address
2630 Sugitani, Toyama, Toyama
TEL
+81-76-434-7363
Homepage URL
miharu@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
2630 Sugitani, Toyama, Toyama
Tel
+81-76-415-8857
rinri@adm.u-toyama.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
| 2024 | Year | 08 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063037
