UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027940 |
|---|---|
| Receipt number | R000032004 |
| Scientific Title | Clinical study on the effect of multifocal contact lens on myopia progression in myopia school children |
| Date of disclosure of the study information | 2017/07/21 |
| Last modified on | 2024/01/05 07:42:52 |
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Basic information
Public title
Clinical study on the effect of multifocal contact lens on myopia progression in myopia school children
Acronym
Multifocal Contact Lens Trial for Suppressing Myopia Progression
Scientific Title
Clinical study on the effect of multifocal contact lens on myopia progression in myopia school children
Scientific Title:Acronym
Multifocal Contact Lens Trial for Suppressing Myopia Progression
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of multifocal contact lens to suppress progress of myopia progression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Refractive power change
Key secondary outcomes
Change in axial length
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
multifocal contact
Interventions/Control_2
normal contact
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
Moderate myopia (objective equivalent spherical power: -1.00 D to -6.00 D)
Key exclusion criteria
Examples of anisometropia and astigmatism beyond 1.5 D
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Hieda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of ophthalmology
Zip code
602-0841
Address
Kajii-Cho 465, Kmigyo-ku, Kyoto City
TEL
075-251-5578
ohieda@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Hieda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of ophthalmology
Zip code
602-0841
Address
Kajii-Cho 465, Kmigyo-ku, Kyoto City
TEL
075-251-5578
Homepage URL
ohieda@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Seed Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of ophthalmology, Tsukuba University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kjii-cho 465, kamigyo-ku, Kyoto city
Tel
0752515578
ohieda@koto.kpu-m.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
| 2017 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
JCRS
Publication of results
Partially published
Result
URL related to results and publications
JCRS
Number of participants that the trial has enrolled
102
Results
under analysis
Results date posted
| 2024 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
in JCRS
Participant flow
end
Adverse events
in JCRS
Outcome measures
in JCRS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There are 32 entries
Management information
Registered date
| 2017 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032004
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
