Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.
-
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.