Myopia control trial with progressive addition lenses in Japanese schoolchildren

ISRCTN ISRCTN28611140
DOI https://doi.org/10.1186/ISRCTN28611140
Secondary identifying numbers C15390532
Submission date
28/06/2006
Registration date
06/07/2006
Last edited
28/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Satoshi Hasebe
Scientific

Department of Ophthalmology
Okayama University Graduate School of Medicine, Dentistry and
Pharmaceutical Sciences
2-5-1 Shikata-cho
Okayama
700-8558
Japan

Phone +81 (86) 235 7297
Email shasebe@md.okayama-u.ac.jp

Study information

Study designRandomised double-masked placebo-controlled cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleMyopia control trial with progressive addition lenses in Japanese schoolchildren
Study objectivesThat progressive addition lenses slow myopia progression and axial length elongation in myopic children, compared with single-focus lenses
Ethics approval(s)Ethics approval received from the ethics panel of Okayama University Medical School on the 21st May 2002 (ref: 105).
Health condition(s) or problem(s) studiedEarly-onset myopia
InterventionFull-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 typeOther
Primary outcome measureCycloplegic autorefraction (D).
Secondary outcome measuresAxial length measurement (mm).
Overall study start date01/07/2002
Completion date10/07/2006

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants95
Key inclusion criteria1. 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
Key exclusion criteriaAppearance of manifest strabismus under refractive correction.
Date of first enrolment01/07/2002
Date of final enrolment10/07/2006

Locations

Countries of recruitment

  • Japan

Study participating centre

Department of Ophthalmology
Okayama
700-8558
Japan

Sponsor information

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

2-5-1 Marunouchi
Chiyodaku
Tokyo
100-8959
Japan

Email voice@mext.go.jp
Website http://www.mext.go.jp/english/index.htm
ROR logo "ROR" https://ror.org/048rj2z13

Funders

Funder type

Government

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

No information available

Tanaka-Chain Optical Company (Japan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/01/2005 Yes No
Results article 01/07/2008 Yes No

Editorial Notes

28/10/2022: Internal review.