UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and safety myopia treatment using Ortho-Keratology lens
Title of the study (Brief title)	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	Yukinobu Okajima
Organization	Toho university omori hospital
Division name	ophthalmology
Address	6-11-1 omorinishi otaku tokyo
TEL	03-3762-4151
Email	yukinobu.okajima@med.toho-u.ac.jp

Public contact
Name of contact person	Yukinobu Okajima
Organization	Toho university omori hospital
Division name	General Affairs Division
Address	6-11-1 omorinishi otaku tokyo
TEL	03-3762-4151
Homepage URL
Email	yukinobu.okajima@med.toho-u.ac.jp

Sponsor
Institute	Toho university
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030776