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| Name | Class |
|---|---|
| Gaozhou Hospital of Traditional Chinese Medicine | OTHER |
| Xinyi traditional Chinese medicine hospital | UNKNOWN |
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Two-month randomized trial comparing three groups.
Two-month randomized non-inferiority trial (the margin of non-inferiority is 20%) comparing three groups: self-refraction with adjustable glasses, receiving adjustable glasses; subjective refraction by an expert refractionist after computer optometry and receiving custom standard glasses; subjective refraction by an expert refractionist after computer optometry and receiving ready-made glasses. The main outcome of this study is the rate of glasses wear on twice-weekly covert evaluation by head teachers. And the continuous teacher assessment of wearing study glasses will be calculated as the number of times wearing glasses/ Total number of separate observations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Self-refraction with adjustable glasses |
|
| Group 2 | Other | Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses |
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| Group 3 | Other | Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustable glasses | Other | The glasses will be used for refraction and wearing within professional instructions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wearing spectacles proportion | The participators in each group may have the different wearing spectacles proportion. | 5 months after the start of the project |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of life after wearing glasses(questionnaires) | The quality of life will be learned by questionnaires | 5 months after the start of the project |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the user's subjective impression（questionnaires） | Evaluation of the user's subjective impression for the three type of glasses will be learned by questionnaires. | 5 months after the start of the project |
| Damaged condition of the glasses |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Congdon, MD, MPH | The Key Laboratory, Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14985292 | Background | He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051. | |
| 19104465 | Background | He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
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| Custom standard glasses | Other | The custom standard glasses are made by the traditional standards after refraction. |
|
| Ready-made glasses | Other | The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction. |
|
The glasses may be damaged during use. At the end of project, every user will have have a questionnaire about damaged condition of glasses, such as missing screws, having scratches on the surface of lens and so on.
| 5 months after the start of the project |
| 20547954 | Background | Li L, Lam J, Lu Y, Ye Y, Lam DS, Gao Y, Sharma A, Zhang M, Griffiths S, Congdon N. Attitudes of students, parents, and teachers toward glasses use in rural China. Arch Ophthalmol. 2010 Jun;128(6):759-65. doi: 10.1001/archophthalmol.2010.73. |
| 21232802 | Background | He M, Congdon N, MacKenzie G, Zeng Y, Silver JD, Ellwein L. The child self-refraction study results from urban Chinese children in Guangzhou. Ophthalmology. 2011 Jun;118(6):1162-9. doi: 10.1016/j.ophtha.2010.10.003. Epub 2011 Jan 12. |
| 24327616 | Background | Zhou Z, Zeng J, Ma X, Pang X, Yi H, Chen Q, Meltzer ME, He M, Rozelle S, Congdon N. Accuracy of rural refractionists in western China. Invest Ophthalmol Vis Sci. 2014 Jan 7;55(1):154-61. doi: 10.1167/iovs.13-13250. |
| 31543351 | Derived | Wang CY, Zhang G, Tang B, Jin L, Huang W, Wang X, Chen T, Zhu W, Xiao B, Wang J, Zhou Z, Tang Z, Liang Y, Crescioni M, Wilson D, McAneney H, Silver JD, Moore B, Congdon N. A Randomized Noninferiority Trial of Wearing Adjustable Glasses versus Standard and Ready-made Spectacles among Chinese Schoolchildren: Wearability and Evaluation of Adjustable Refraction III. Ophthalmology. 2020 Jan;127(1):27-37. doi: 10.1016/j.ophtha.2019.08.002. Epub 2019 Aug 14. |