UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005054 |
|---|---|
| Receipt number | R000005268 |
| Scientific Title | Clinical trial to evaluate effect of spectacle lens that reduces myopia progression |
| Date of disclosure of the study information | 2011/02/08 |
| Last modified on | 2015/07/01 11:18:14 |
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Basic information
Public title
Clinical trial to evaluate effect of spectacle lens that reduces myopia progression
Acronym
Clinical trial of the spectacle lens that reduces myopia progression
Scientific Title
Clinical trial to evaluate effect of spectacle lens that reduces myopia progression
Scientific Title:Acronym
Clinical trial of the spectacle lens that reduces myopia progression
Region
| Japan |
Condition
Condition
Myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventive effects of the spectacle lens that reduces myopia progression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Myopic progression in 2 years after the trial start
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are 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
Wearing eyeglasses that reduces myopic progression
Interventions/Control_2
Wearing normal eyeglasses
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
Mild myopia (from -1.5 to -4.5 diopters) and minimal astigmatism (< 1.5 diopter).
Those who don't have any eye disease except refractive error.
Those whose father or mother have myopia.
Key exclusion criteria
corrected visual acuity is less than 1.0.
Those who have strabismus.
Those who wore bifocal glasses or progressive lens in the past year.
Those who wore orthokeratology lens in the past.
Those who participate in other similar trials.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Fujikado |
Organization
Osaka university graduate school of medicine
Division name
Department of applied visual science
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3941
fujikado@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kanda |
Organization
Osaka university graduate school of medicine
Division name
Department of applied visual science
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3941
Homepage URL
kanda@sensory.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of applied visual science, Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of applied visual science, Osaka university graduate school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa Medical University Hospital
Keio University Hospital
University of Tsukuba Hospital
Okayama University Hospital
University Hospital, Kyoto Prefectural University of Medicine
Name of secondary funder(s)
Carl Zeiss Vision Japan
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
| 2011 | Year | 02 | Month | 08 | 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
There were no adverse events related to this clinical trial.
There was not significant difference between the two groups as measured by change in refractive power and axial length of the eye.
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
| 2011 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 08 | Day |
Last modified on
| 2015 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005268
