UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005054
Receipt number R000005268
Scientific Title Clinical trial to evaluate effect of spectacle lens that reduces myopia progression
Date of disclosure of the study information 2011/02/08
Last modified on 2015/07/01 11:18:14

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Basic information

Public title

Clinical trial to evaluate effect of spectacle lens that reduces myopia progression

Acronym

Clinical trial of the spectacle lens that reduces myopia progression

Scientific Title

Clinical trial to evaluate effect of spectacle lens that reduces myopia progression

Scientific Title:Acronym

Clinical trial of the spectacle lens that reduces myopia progression

Region

Japan


Condition

Condition

Myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the preventive effects of the spectacle lens that reduces myopia progression.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Myopic progression in 2 years after the trial start

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Wearing eyeglasses that reduces myopic progression

Interventions/Control_2

Wearing normal eyeglasses

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

12 years-old >=

Gender

Male and Female

Key inclusion criteria

Mild myopia (from -1.5 to -4.5 diopters) and minimal astigmatism (< 1.5 diopter).
Those who don't have any eye disease except refractive error.
Those whose father or mother have myopia.

Key exclusion criteria

corrected visual acuity is less than 1.0.
Those who have strabismus.
Those who wore bifocal glasses or progressive lens in the past year.
Those who wore orthokeratology lens in the past.
Those who participate in other similar trials.

Target sample size

210


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Fujikado

Organization

Osaka university graduate school of medicine

Division name

Department of applied visual science

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3941

Email

fujikado@ophthal.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Kanda

Organization

Osaka university graduate school of medicine

Division name

Department of applied visual science

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3941

Homepage URL


Email

kanda@sensory.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of applied visual science, Osaka university graduate school of medicine

Institute

Department

Personal name



Funding Source

Organization

Department of applied visual science, Osaka university graduate school of medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Asahikawa Medical University Hospital
Keio University Hospital
University of Tsukuba Hospital
Okayama University Hospital
University Hospital, Kyoto Prefectural University of Medicine


Name of secondary funder(s)

Carl Zeiss Vision Japan


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

2011 Year 02 Month 08 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

There were no adverse events related to this clinical trial.
There was not significant difference between the two groups as measured by change in refractive power and axial length of the eye.

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

2011 Year 01 Month 12 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 02 Month 08 Day

Last modified on

2015 Year 07 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005268


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name