UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014362
Receipt number R000016449
Scientific Title Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression
Date of disclosure of the study information 2014/06/24
Last modified on 2020/08/25 21:42:29

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Basic information

Public title

Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression

Acronym

Preventing myopia progression which combined orthokeratology and atropine 0.01% ophthalmic solution

Scientific Title

Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression

Scientific Title:Acronym

Preventing myopia progression which combined orthokeratology and atropine 0.01% ophthalmic solution

Region

Japan


Condition

Condition

Myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the additive effects of orthokeratology and atropine 0.01% ophthalmic solution in preventing axial length elongation in children with myopia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Efficacy: Increase in axial length over a 2-year period

Key secondary outcomes

Safty: Decrease in corneal endothelial cell density over a 2-year period
Efficacy: Increase in axial length over a 1-year period
Safty: Decrease in corneal endothelial cell density over a 1-year period


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Orthokeratology contact lens

Interventions/Control_2

Atropine 0.01% ophthalmic solution

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

8 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Cycloplegic spherical equivalent refractive error of -1.00 to -6.00 D in both eyes
2) Astigmatism of less than 1.50 D in both eyes
3) Anisometropia of less than 1.50 D
4) Best corrected visual acuity of more than 1.0 in both eyes

Key exclusion criteria

1) Eye disorders such as strabismus and amblyopia
2) Systemic disorders such as cardiac or respiratory illness
3) Birth weight of less than 1500 g
4) History of hypersensitivity to atropine
5) Using of orthokeratology and/or atropine ophthalmic solutions

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Nozomi
Middle name
Last name Kinoshita

Organization

Saitama Medical Center, Jichi Medical University

Division name

Department of Ophthalmology

Zip code

330-8503

Address

1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan

TEL

048-647-2111

Email

nozomik@omiya.jichi.ac.jp


Public contact

Name of contact person

1st name Nozomi
Middle name
Last name Kinoshita

Organization

Saitama Medical Center, Jichi Medical University

Division name

Department of Ophthalmology

Zip code

330-8503

Address

1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan

TEL

048-647-2111

Homepage URL

http://researchmap.jp/nozomik1012/

Email

nozomik@omiya.jichi.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Saitama Medical Center, Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI Grant Number JP26462646 from the Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Konno Eye Clinic
Omiya Hamada Eye Clinic

Name of secondary funder(s)

Universal View Co., Ltd.


IRB Contact (For public release)

Organization

The ethical committee at Saitama Medical Centre, Jichi Medical University

Address

1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan

Tel

048-647-2111

Email

ycanda-tky@umin.ac.jp


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

こんの眼科/Konno Eye Clinic
大宮はまだ眼科/Omiya Hamada Eye Clinic


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 24 Day


Related information

URL releasing protocol

http://researchmap.jp/nozomik1012/

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1038/s41598-020-69710-8

Number of participants that the trial has enrolled

80

Results

Dataset analyzed in the above paper
https://doi.org/10.17632/y58rh8bfkv.7

Results date posted

2019 Year 03 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 07 Month 29 Day

Baseline Characteristics

Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8

Participant flow

Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8

Adverse events

Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8

Outcome measures

Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 06 Month 20 Day

Date of IRB

2014 Year 06 Month 20 Day

Anticipated trial start date

2014 Year 06 Month 30 Day

Last follow-up date

2019 Year 03 Month 28 Day

Date of closure to data entry

2019 Year 03 Month 28 Day

Date trial data considered complete

2019 Year 03 Month 28 Day

Date analysis concluded

2019 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 06 Month 24 Day

Last modified on

2020 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016449


Research Plan
Registered date File name
2017/12/24 Trial protocol (Kinoshita).docx

Research case data specifications
Registered date File name
2018/03/04 Data set (Kinoshita).xlsx

Research case data
Registered date File name
2019/12/03 Data set (Kinoshita).xlsx