Myopia control trial with progressive addition lenses in Japanese schoolchildren
| ISRCTN | ISRCTN28611140 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28611140 |
| Protocol serial number | C15390532 |
| Sponsor | Japanese Ministry of Education, Culture, Sports Science, and Technology (Japan) |
| Funders | Japanese Ministry of Education, Culture, Sports and Technology (Japan) - Scientific research (C), Tanaka-Chain Optical Company (Japan) |
- 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
Contact information
Prof Satoshi Hasebe
Scientific
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 |
|---|---|
| shasebe@md.okayama-u.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-masked placebo-controlled cross-over study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Myopia control trial with progressive addition lenses in Japanese schoolchildren |
| Study objectives | That 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) studied | 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 |
| Primary outcome measure(s) |
Cycloplegic autorefraction (D). |
| Key secondary outcome measure(s) |
Axial length measurement (mm). |
| Completion date | 10/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 95 |
| Key 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 |
| Key exclusion criteria | Appearance of manifest strabismus under refractive correction. |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 10/07/2006 |
Locations
Countries of recruitment
- Japan
Study participating centre
Department of Ophthalmology
Okayama
700-8558
Japan
700-8558
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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 | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/10/2022: Internal review.
