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| Name | Class |
|---|---|
| State Scholarships Foundation | UNKNOWN |
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The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.
A prospective, randomized, controlled clinical trial was designed for assessing the effect of single-vision spectacles on myopic progression. 30 myopic subjects, aged 6-16 years old, with a spherical equivalent refraction between -0.50D and -6.00D, were recruited. A random number table was used to allocate participants into either a) part-time use of single-vision spectacles, or b) full-time use of single-vision spectacles. Part-time use was for 4-6 hours a day, 7 days a week for a year. Clinical assessment included follow-up at 6 months and at 12 months upon allocation. The primary outcomes were a) change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction, and b) change in axial eye length (AL). The secondary outcomes were a) change in choroidal thickness (ChT), and b) assessment of the subjective tolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Part-time myopia correction with single-vision spectacles |
|
| Control Group | Active Comparator | Full-time myopia correction with single-vision spectacles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-Vision Spectacles | Device | Spectacle correction for myopia treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction. | Baseline to 6-months, and baseline to 12-months. | |
| Change in axial length (AL). | Baseline to 6-months, and baseline to 12-months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in choroidal thickness (ChT). | Baseline to 6-months, and baseline to 12-months. | |
| Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study. | This questionnaire is formed by the researchers participating in this study and is aimed at providing a qualitative assessment of the subjective tolerance of included children wearing spectacles. It incorporates 6 questions and is not based on a scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Papageorgiou" General Hospital | Thessaloniki | 56429 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25000870 | Background | Vasudevan B, Esposito C, Peterson C, Coronado C, Ciuffreda KJ. Under-correction of human myopia--is it myopigenic?: a retrospective analysis of clinical refraction data. J Optom. 2014 Jul-Sep;7(3):147-52. doi: 10.1016/j.optom.2013.12.007. Epub 2014 May 10. | |
| 27796670 | Background | Sun YY, Li SM, Li SY, Kang MT, Liu LR, Meng B, Zhang FJ, Millodot M, Wang N. Effect of uncorrection versus full correction on myopia progression in 12-year-old children. Graefes Arch Clin Exp Ophthalmol. 2017 Jan;255(1):189-195. doi: 10.1007/s00417-016-3529-1. Epub 2016 Oct 29. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Baseline to 12-months. |
| 31854025 | Background | Logan NS, Wolffsohn JS. Role of un-correction, under-correction and over-correction of myopia as a strategy for slowing myopic progression. Clin Exp Optom. 2020 Mar;103(2):133-137. doi: 10.1111/cxo.12978. Epub 2019 Dec 18. |