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

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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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name