Condition category
Eye Diseases
Date applied
28/06/2006
Date assigned
06/07/2006
Last edited
30/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://ww3.tiki.ne.jp/~hamaichi/ophthalmology/

Contact information

Type

Scientific

Primary contact

Prof Satoshi Hasebe

ORCID ID

Contact details

Department of Ophthalmology
Okayama University Graduate School of Medicine
Dentistry and
Pharmaceutical Sciences
2-5-1 Shikata-cho
Okayama
700-8558
Japan
+81 (86) 235 7297
shasebe@md.okayama-u.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C15390532

Study information

Scientific title

Acronym

Study hypothesis

That progressive addition lenses slow myopia progression and axial length elongation in myopic children, compared with single-focus lenses

Ethics approval

Ethics approval received from the ethics panel of Okayama University Medical School on the 21st May 2002 (ref: 105).

Study design

Randomised double-masked placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Early-onset myopia

Intervention

Full-time wearing progressive addition lenses with near addition power of 1.50D (SOLA Myopia Control [MC] lens, Sola International) versus control group receiving single focus lenses.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cycloplegic autorefraction (D).

Secondary outcome measures

Axial length measurement (mm).

Overall trial start date

01/07/2002

Overall trial end date

10/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Experience of wearing spectacles to correct myopia
2. Non-cycloplegic autorefraction (Spherical Equivalent [SE]) from -6.00 to -1.25 D
3. Astigmatism less than 1.50 D
4. Aniseiconia less than 1.50 D
5. Best-corrected visual acuity more than 20/20
6. No manifest strabismus with refractive correction
7. Birth weight more than 1250 g
8. No eye disease except for refractive errors
9. No experience of wearing progressive addition lenses or contact lenses

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

95

Participant exclusion criteria

Appearance of manifest strabismus under refractive correction.

Recruitment start date

01/07/2002

Recruitment end date

10/07/2006

Locations

Countries of recruitment

Japan

Trial participating centre

Department of Ophthalmology
Okayama
700-8558
Japan

Sponsor information

Organisation

Japanese Ministry of Education, Culture, Sports Science, and Technology (Japan)

Sponsor details

2-5-1 Marunouchi
Chiyodaku
Tokyo
100-8959
Japan
voice@mext.go.jp

Sponsor type

Government

Website

http://www.mext.go.jp/english/index.htm

Funders

Funder type

Government

Funder name

Japanese Ministry of Education, Culture, Sports and Technology (Japan) - Scientific research (C)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Tanaka-Chain Optical Company (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15692770
2. http://www.ncbi.nlm.nih.gov/pubmed/18579755

Publication citations

  1. Hasebe S, Nonaka F, Nakatsuka C, Ohtsuki H, Myopia control trial with progressive addition lenses in Japanese schoolchildren: baseline measures of refraction, accommodation, and heterophoria., Jpn. J. Ophthalmol., 49, 1, 23-30, doi: 10.1007/s10384-004-0131-6.

  2. Hasebe S, Ohtsuki H, Nonaka T, Nakatsuka C, Miyata M, Hamasaki I, Kimura S, Effect of progressive addition lenses on myopia progression in Japanese children: a prospective, randomized, double-masked, crossover trial., Invest. Ophthalmol. Vis. Sci., 2008, 49, 7, 2781-2789, doi: 10.1167/iovs.07-0385.

Additional files

Editorial Notes