UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026812 |
|---|---|
| Receipt number | R000030776 |
| Scientific Title | Effectiveness and safety myopia treatment using Ortho-Keratology lens |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2017/03/31 18:04:10 |
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Basic information
Public title
Effectiveness and safety myopia treatment using Ortho-Keratology lens
Acronym
Effectiveness and safety myopia treatment using Ortho-Keratology lens
Scientific Title
Effectiveness and safety myopia treatment using Ortho-Keratology lens
Scientific Title:Acronym
Effectiveness and safety myopia treatment using Ortho-Keratology lens
Region
| Japan |
Condition
Condition
miopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is influence of orthokeratology lens,using visual acuity,intraocular pressure,topography analysis,by measurement of corneal endothelial cell,changes in corneal surface,stroma and endothelium by confocal microscopy,tear meniscus change due to DR1,Temperature change due to corneal thermography.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity,intraocular pressure,topography,corneal endothelial cell,confocal microscopy,DR1,corneal thermography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
This study is using visual acuity,intraocular pressure,topography analysis,by measurement of corneal endothelial cell,changes in corneal surface,stroma and endothelium by confocal microscopy,tear meniscus change due to DR1,Temperature change due to corneal thermography.influence of orthokeratology lens after 1month,3month.
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
miopia
agreed orthokeratology lens
agreed informed consent
Key exclusion criteria
less than 15years old
not agreed orthokeratology lens
not agreed informed consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukinobu Okajima |
Organization
Toho university omori hospital
Division name
ophthalmology
Zip code
Address
6-11-1 omorinishi otaku tokyo
TEL
03-3762-4151
yukinobu.okajima@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukinobu Okajima |
Organization
Toho university omori hospital
Division name
General Affairs Division
Zip code
Address
6-11-1 omorinishi otaku tokyo
TEL
03-3762-4151
Homepage URL
yukinobu.okajima@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030776
