UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063023 |
|---|---|
| Receipt number | R000072115 |
| Scientific Title | Short-term clinical study to evaluate changes in ocular parameters under various visual conditions |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/19 16:22:13 |
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Basic information
Public title
Short-term clinical study to evaluate changes in ocular reaction under various visual conditions
Acronym
Short-term study of Blur
Scientific Title
Short-term clinical study to evaluate changes in ocular parameters under various visual conditions
Scientific Title:Acronym
Short-term study of Blur
Region
| Japan |
Condition
Condition
Myopia and myopic astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between Quality of Vision (QOV) and myopia control efficacy by evaluating choroidal thickness and accommodation under different visual conditions.
Basic objectives2
Others
Basic objectives -Others
Basic Research
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in choroidal thickness after 30 minutes of movie viewing
Key secondary outcomes
Accommodation during movie viewing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Study Day 1: Participants will view an unprocessed, clear video image.
Study Day 2 (on a different day from Day 1): Participants will view a video image processed with a blur equivalent to +1.00 diopter defocus.
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
| 7 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who have provided written informed consent to participate in the study.
Key exclusion criteria
- having any ocular diseases requiring treatment other than for refractive errors (e.g., dry eye disease, allergic eye diseases).
- having the history of any ocular surgeries that may affect visual acuity (e.g., corneal transplantation, corneal refractive surgery, retinal detachment surgery).
- having corneal diseases associated with irregular astigmatism that may affect visual acuity (e.g., keratoconus).
- having the history of any myopia control treatment within the past 12 months (e.g., orthokeratology, atropine eye drops, multifocal spectacles, multifocal contact lenses, dietary supplements).
- having a best-corrected visual acuity of less than 0.8 (decimal).
- cylindrical power of subjective refraction is greater than -1.50 D.
- spherical power of subjective refraction is outside the range of +2.00 D to -6.00 D.
- anisometropia greater than 1.50 D.
- having the history of participating another clinical study that may affect visual acuity within the past 30 days.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fujikado |
Organization
The University of Osaka
Division name
Graduate School of Frontier Biosciences
Zip code
565-0871
Address
1-3 Yamadaoka, Suita, Osaka
TEL
06-6877-5111
fujikado@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Hirata |
Organization
Menicon Co., Ltd.
Division name
Medical Affairs & Scientific Strategy Department
Zip code
460-0006
Address
3-21-19, Aoi, Naka-ku, Nagoya
TEL
080-8651-6800
Homepage URL
h-hirata@menicon.co.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Menicon Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Frontier Biosciences, The University of Osaka
Address
1-3 Yamadaoka, Suita, Osaka
Tel
06-6877-5111
konishi-s@office.osaka-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
愛知医科大学眼科クリニックMiRAI（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | 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
31
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
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072115
