UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter study of Orthokeratorogy for infancy using " Breath-O Correct"
Title of the study (Brief title)	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	Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3821
Email	fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person	Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3821
Homepage URL
Email	fwic7788@mb.infoweb.ne.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015078