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Myopia control trial with progressive addition lenses in Japanese schoolchildren
DOI 10.1186/ISRCTN28611140
ClinicalTrials.gov identifier
EudraCT number
Public title Myopia control trial with progressive addition lenses in Japanese schoolchildren
Scientific title
Acronym N/A
Serial number at source C15390532
Study hypothesis That progressive addition lenses slow myopia progression and axial length elongation in myopic children, compared with single-focus lenses
Lay summary
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
Countries of recruitment Japan
Disease/condition/study domain Early-onset myopia
Participants - 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
Participants - exclusion criteria Appearance of manifest strabismus under refractive correction.
Anticipated start date 01/07/2002
Anticipated end date 10/07/2006
Status of trial Completed
Patient information material
Target number of participants 95
Interventions 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.
Primary outcome measure(s) Cycloplegic autorefraction (D).
Secondary outcome measure(s) Axial length measurement (mm).
Sources of funding 1. Japanese Ministry of Education, Culture, Sports and Technology (Japan) - Scientific research (C)
2. Tanaka-Chain Optical Company (Japan)
Trial website http://ww3.tiki.ne.jp/~hamaichi/ophthalmology/
Publications Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15692770
2. http://www.ncbi.nlm.nih.gov/pubmed/18579755
Contact name Prof  Satoshi  Hasebe
  Address Department of Ophthalmology
Okayama University Graduate School of Medicine, Dentistry and
Pharmaceutical Sciences
2-5-1 Shikata-cho
  City/town Okayama
  Zip/Postcode 700-8558
  Country Japan
  Tel +81 (86) 235 7297
  Fax +81 (86) 222 5059
  Email shasebe@md.okayama-u.ac.jp
Sponsor Japanese Ministry of Education, Culture, Sports Science, and Technology (Japan)
  Address 2-5-1 Marunouchi
  City/town Tokyo
  Zip/Postcode 100-8959
  Country Japan
  Email voice@mext.go.jp
  Sponsor website: http://www.mext.go.jp/english/index.htm
Date applied 28/06/2006
Last edited 30/06/2008
Date ISRCTN assigned 06/07/2006
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