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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002597
Receipt No. R000003171
Scientific Title Introduction of Orthokeratology
Date of disclosure of the study information 2009/10/07
Last modified on 2009/10/07

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Basic information
Public title Introduction of Orthokeratology
Acronym Introduction of Orthokeratology
Scientific Title Introduction of Orthokeratology
Scientific Title:Acronym Introduction of Orthokeratology
Region
Japan

Condition
Condition Ametropia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Introduction of Orthokeratology
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity, refraction, corneal analysis
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 We evaluate visual acuity, refraction, improvement condition of the cornea shape.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The myopia and astigmatic ametropia patient that refraction value is stable.
The corner conjunctiva does not have remarkable fluoresceine staining, and being more than 5mm by a Schirmer's test for five minutes.
There be cornea endothelium density more than 2,000 /mm2.
Key exclusion criteria The patient who does not meet the adaptation.
The patient who cannot obey the instructions of the instruction manual.
The patient that it is difficult to periodical examination.
A pregnant woman, a woman nursing or the woman who has a plan of the pregnancy.
cornea diseases.
A patient (for example, AIDS, autoimmune disease) with the immune disease or a diabetic.
A patient has allergy for the contact lens.
Corneal infectious disease.
The patient who has ophthalmopathy, the damage, deformity to have an influence on the cornea, the conjunctiva, an eyelid.
Dry eye patient.
The patient who deteriorates of the cornea perception.
The patient who has injection or foreign body sensation.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Naito
Organization Tokushima university hospital
Division name Department of Ophthalmology
Zip code
Address Kuramoto cho 2-50-1, Tokushima city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima university hospital
Division name Department of Ophthalmology
Zip code
Address Kuramoto cho 2-50-1, Tokushima city
TEL
Homepage URL
Email

Sponsor
Institute Tokushima university hospital
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 10 Month 07 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 Preinitiation
Date of protocol fixation
2009 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 07 Day
Last modified on
2009 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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