UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012922 |
|---|---|
| Receipt number | R000015078 |
| Scientific Title | Multicenter study of Orthokeratorogy for infancy using " Breath-O Correct" |
| Date of disclosure of the study information | 2014/01/25 |
| Last modified on | 2018/01/11 21:13:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter study of Orthokeratorogy for infancy using " Breath-O Correct"
Acronym
Multicenter study of Orthokeratorogy for infancy
Scientific Title
Multicenter study of Orthokeratorogy for infancy using " Breath-O Correct"
Scientific Title:Acronym
Multicenter study of Orthokeratorogy for infancy
Region
| Japan |
Condition
Condition
myopia and myopic astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safty and efficacy of Orthokeratorogy for infancy with myopia and myopic astigmatism
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safty: uncorrected visual acuity
Efficacy: Decrease of corneal endothelial cell density
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
contact lens
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participant must meet all of the following conditions listed below;
1) Patient who is 6 years old to 16 years old (including 6 years old and 16 years old), at the time of the consent acquisition.
2) Patient with -1.00 to -4.00D myopia.
3) Patient with astigmatism (spherical power being less than 1/2 of cylindrical power, and less -0.75D).
4) Patient whom examiner is able to observe both eyes.
5) Patient who is able to attend the hospital during the research.
6) Patient whose parent is able to take care the RGP lenses.
7) Patient who is able to acquire a consent of his/her adult legal representative.
Key exclusion criteria
Those who is correspond to any one of the following conditions, and who is considered to be inappropriate by the doctors, must be excluded from the research.
1) Patient with acute or sub-acute inflammation of anterior eye part.
2) Patient with eye infection.
3) Patient with uveitis.
4) Patient with cornea perception.
5) Patient with corneal epithelium defect.
6) Patient with eyelid abnormality.
7) Patient with lacrimal apparatus disease.
8) Patient who may suffer allergen reaction or exacerbation on eye surface or eye adnexa (that cannot controlled by ocular instillation), due to the use of contact lenses or contact lens solutions.
9) Patient who had keratorefractive surgery.
10) Patient with indication of keratoconus or other corneal disease.
11) Pregnant (potentially pregnant) or breastfeeding women.
12) Patient with immune disorders such as AIDS, autoimmune disorder, or diabetic.
13) Patient with any other eye disease that may effect to the cornea, conjunctiva, or eyelid, or with injury or malformation.
14) Patient with eye hyperemia or foreign body sensation.
15) Patient with systemic disease, or patient with potential systemic disease which may be effected by wearing Breath-O-Correct.
16) Patient who might not be able to comply with instructions by the doctors.
17) Patient who might not be able to properly use or take care Breath-O-Correct.
18) Patient who might not be able to attend for periodical examination.
19) Patient who might not be able to properly adopt hygiene management of Breath-O-Correct.
20) Patient who is extremely nervous.
21) Patient who usually stay in a dry environment (ex. Continuous air-conditioner use).
22) Patient with jobs that require continuous stable vision, and who need to stop working due to an un-regularly change of eye sight.
23) Any other reasons based on the doctors' judgment.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
fwic7788@mb.infoweb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
Homepage URL
fwic7788@mb.infoweb.ne.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology,Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology,Ehime University, School of Medicine
Department of Ophthalmology,Kyoto Prefectural University of Medicine
Universal View Co., Ltd.
Name of secondary funder(s)
TORAY
Universal View Co., Ltd.
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
| 2014 | Year | 01 | Month | 25 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 29 | 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
| 2014 | Year | 01 | Month | 22 | Day |
Last modified on
| 2018 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015078
