UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019237 |
|---|---|
| Receipt number | R000019799 |
| Scientific Title | Effect of dual-focus soft contact lens wear on myopia progression |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2017/09/08 20:23:42 |
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Basic information
Public title
Effect of dual-focus soft contact lens wear on myopia progression
Acronym
Effect of soft contact lens wear on myopia progression
Scientific Title
Effect of dual-focus soft contact lens wear on myopia progression
Scientific Title:Acronym
Effect of soft contact lens wear on myopia progression
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Singel vision spectacle and center-distance bifocal contact lens are done a comparison wearing and examined the myopia progress suppression effect by the center-distance bifocal contact lens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of subjective refractivity, objective refractivity and optic axis length between two groups after 1 year from wearing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Spectacles group
One year
Interventions/Control_2
Bifocal contact lenses group
One year
Replacement on a daily basis
Over 8 hour wearing per day
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
| 10 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No experience of contact lens wear
-1.0D to -6.0D refraction in each eyes under the non-accommodative palsy
Total astigmatism diopter within -1.5D in each eyes
Corrected visual acuity over 1.0 in each eyes
No misalignment of the eyes
No history of premature infant
No maldevelopment of the eyes and systemic
No use of drug
Be able to wear 1 week in contact lenses group (More than once a practice for wearing)
Be able to obtain the voluntary consent document by patient and the agreemnt of legally acceptable representative
Key exclusion criteria
If principal investigator and investigator has determined unsuitable
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Funaki Toshinari |
Organization
Juntendo University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1093
funa5150@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Funaki Toshinari |
Organization
Juntendo University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1093
Homepage URL
funa5150@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
SEED 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
Address
Tel
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
| 2015 | Year | 10 | Month | 05 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 05 | Day |
Last modified on
| 2017 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019799
