UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055238 |
|---|---|
| Receipt number | R000063081 |
| Scientific Title | Evaluation of compliance with instructions on smartphone viewing by using Eye Care-Clip |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/02/14 17:38:29 |
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Basic information
Public title
Evaluation of compliance with instructions on smartphone viewing by using Eye Care-Clip
Acronym
Evaluation of compliance with instructions on smartphone viewing
Scientific Title
Evaluation of compliance with instructions on smartphone viewing by using Eye Care-Clip
Scientific Title:Acronym
Evaluation of compliance with instructions on smartphone viewing
Region
| Japan |
Condition
Condition
normal subjects
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether people comply with the instruction to keep smartphones at a distance of 30 cm or more from the eyes when viewing them.
Basic objectives2
Others
Basic objectives -Others
Grasping the actual situation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of people who were able to comply with the instruction to keep smartphone viewing distance at 30cm or more after receiving the instruction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
to be aware of keeping smartphones at a viewing distance of at least 30cm
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
| 12 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers aged 12 to 29 years who wear glasses in their daily lives and use smartphones continuously for at least 30 minutes every day
Key exclusion criteria
1. Those with corrected visual acuity of less than 1.0 in either eye
2. Those with a history of treatment for strabismus, amblyopia, or other eye diseases that result in reduced visual acuity
3. Those deemed inappropriate by the researchers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Iimori |
Organization
Ehime University
Division name
Department of Ophthalmology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime
TEL
089-960-5361
ycrgx240@gmail.com
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Iimori |
Organization
Ehime University
Division name
Department of Ophthalmology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime
TEL
089-960-5361
Homepage URL
ycrgx240@gmail.com
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
nstitutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-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
| 2024 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 01 | 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 | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063081
