UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059598 |
|---|---|
| Receipt number | R000067821 |
| Scientific Title | Repeated Low-level Red Light for Myopia Progression Study: A 1-year, International, Multicenter, Multiethnic Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/10/31 01:18:19 |
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Basic information
Public title
Repeated Low-level Red Light for Myopia Progression Study: A 1-year, International, Multicenter, Multiethnic Randomized Controlled Trial
Acronym
An IPOSC Study
Scientific Title
Repeated Low-level Red Light for Myopia Progression Study: A 1-year, International, Multicenter, Multiethnic Randomized Controlled Trial
Scientific Title:Acronym
An IPOSC Study
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of RLRL therapy to reduce spherical equivalent refractive error (SER) progression in myopic children.
To assess the efficacy of RLRL therapy to reduce axial length (AL) elongation in myopic children.
Basic objectives2
Others
Basic objectives -Others
To assess the change in the other ocular biometric parameters (e.g., anterior chamber depth (ACD), corneal curvature (CC), choroidal thickness (CT)) except AL after RLRL therapy in myopic children.
To assess the safety of RLRL therapy in myopic children.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cycloplegic SER
Changes in AL
Key secondary outcomes
Changes in the rate of SER and AL increase
Changes in other biometric parameters except AL: ACD, CC, WTW, CT and choroidal structures.
Best corrected visual acuity (BCVA), intraocular pressures, ocular and systemic symptoms, ocular signs assessed by slit lamp biomicroscopy and binocular indirect ophthalmoscopy, and questionnaire for self-reported visual function
Pupil size in room light measured by pupillometer (option)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects will be treated with a Myopia Management Devices (Eyerising International, South Yarra VIC, Australia) 5 days a week, three minutes per session, twice a day, with a minimum interval of 4 hours, under the supervision of their parents for a year.
Interventions/Control_2
Subjects will be treated with Sham device 5 days a week, three minutes per session, twice a day, with a minimum interval of 4 hours, under the supervision of their parents for a year.
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age: 6 to 12 years at enrolment
2) Myopia: Cycloplegic SER -1.0 to -7.0 diopters (D) in each eye
3) Anisometropia : < 1.5 D
4) Astigmatism: < 1.5 D
5) Best corrected visual acuity (BCVA) 20/25 or better.
6) Informed parental consent
Key exclusion criteria
1) Ophthalmic diseases, conditions, or syndromes other than ammetropia and myelinated nerve fiber layer, or prematurity (less than 36 weeks of gestation)
2) Previous use of optical or pharmacologic treatment for myopia control (e.g., defocusing spectacle or contact lenses, orthokeratology, atropine, or pirenzepine)
3) Systemic diseases (e.g., endocrine, cardiac diseases) and developmental anomalies
4) Inability to attend regular follow up visits
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Ohno-Matsui |
Organization
Institute of Science Tokyo
Division name
Ophthalmology
Zip code
1138519
Address
Department of Ophthalmology, Institute of Science Tokyo, 1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5681
k.ohno.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Institute of Science Tokyo
Division name
Ophthalmology
Zip code
1138519
Address
Department of Ophthalmology, Institute of Science Tokyo, 1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5681
Homepage URL
t.hiroyuki.oph@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Eyelens
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
Institution of Science Tokyo Department of Ophthalmology
Address
Department of Ophthalmology, Institute of Science Tokyo, 1-5-45 Yushima Bunkyo-ku, Tokyo 1138519, Japan
Tel
03-5803-5681
t.hiroyuki.oph@tmd.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
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2025 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067821
