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Myopia is considered to be the most common type of refractive error, and the incidence of myopia has shown a trend of low age. Recent studies found that the new aspheric microlens spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. A new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.
Myopia is considered to be the most common type of refractive error, and it has increased rapidly worldwide. The vision damage caused by uncorrected myopia seriously affects the quality of life, may lead to poor academic performance of children, and cause considerable economic burden. About 90% of vision damage caused by myopia can be prevented by cost-effective interventions or treatment.
In recent years, the incidence of myopia has shown a trend of low age. Therefore, clinical intervention should be carried out in the childhood stage, which is the key period of eye development, to control the progress of myopia. A recent 2-year randomized controlled study in China found that the new aspheric microlens myopia control spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. Different studies have found or proved the technical principle of the new aspheric defocusing microlens.
Animal experiments found that the direction, intensity and regional distribution of optical defocus signals have a substantial impact on the growth of eyes; The diopter of peripheral relative hyperopia can affect the central myopia; The changes of myopia and optical defocus in the nasal and temporal regions can change the shape and peripheral refraction of the eyes; Local changes in the effective focus of the eye will lead to regional changes in eye growth and refractive error. Based on the findings of animal experiments, the new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.
A prospective, single-center, open-label, non-inferiority randomized controlled trial is developed to evaluate the effectiveness and safety of partition multi-point defocused myopia management spectacle lens among children in China in myopia control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The participants wear the partition defocus myopia management spectacle lens. |
|
| Control group | Active Comparator | spectacle lenses with aspherical lenslets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partition defocus myopia management spectacle lens | Other | Participants in the intervention group will receive the partition defocus myopia management spectacles lens and receive follow-up checks. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of spherical equivalent refraction (SER) at two years | The difference of SER (Diopter) at two years from baseline. SER will be measured every year after cycloplegia. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of axial length (AL) at two years | The difference of AL (mm) at two years from baseline. AL will be measured every half year by IOLMaster700. | 2 years |
| Change of anterior chamber depth (ACD) at two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yangfa Zeng | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23109740 | Background | Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12. | |
| 33388160 | Background | Modjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D; Task Force on Myopia. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children: The Academy's Task Force on Myopia. Ophthalmology. 2021 Jun;128(6):816-826. doi: 10.1016/j.ophtha.2020.10.040. Epub 2020 Dec 30. |
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| Spectacle lenses with aspherical lenslets | Other | Participants in the control group will receive the spectacle lenses with aspherical lenslets and receive follow-up checks. |
|
The difference of ACD(mm) at two years from baseline. ACD will be measured every half year by IOLMaster700.
| 2 years |
| Change of lens thickness (LT) at two years | The difference of LT (mm) at two years from baseline. LT will be measured every half year by IOLMaster700. | 2 years |
| Change of corneal power (CP) at two years | The difference of CP (Diopter) at two years from baseline. CP will be measured every half year by IOLMaster700. | 2 years |
| Best corrected visual acuity at two years | Best corrected visual acuity measured every year by EDTRS visual acuity chart after cycloplegia. | 2 years |
| Binocular visual function at two years | Binocular visual function which will be measured every year is a qualitative outcome assessed by a series of tests. | 2 years |
| Choroidal thickness at two years | The difference of Choroidal thickness (μm) at two years from baseline. Choroidal thickness will be measured every year by OCTA. | 2 years |
| Visual scale score at six months | Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) and scaled from 0 (poor quality of life) to 100 (good quality of life). | 6 months |
| Visual scale score at two years | Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) and scaled from 0 (poor quality of life) to 100 (good quality of life). | 2 years |
| Time length of wearing spectcales at two years | Time length of wearing spectcales collected every half year. Participants report the approximate time of wearing glasses per day and the days of wearing glasses per week. | 2 years |
| Safty of wearing the spectacle lens | Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations based on symptoms and signs, intraocular pressure,slit lamp and ocular fundus checks. | 2 years |
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| 10343811 | Background | Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. doi: 10.1016/s0042-6989(98)00229-6. |
| 3603011 | Background | Wallman J, Gottlieb MD, Rajaram V, Fugate-Wentzek LA. Local retinal regions control local eye growth and myopia. Science. 1987 Jul 3;237(4810):73-7. doi: 10.1126/science.3603011. |
| 23026012 | Background | Huang J, Hung LF, Smith EL 3rd. Recovery of peripheral refractive errors and ocular shape in rhesus monkeys (Macaca mulatta) with experimentally induced myopia. Vision Res. 2012 Nov 15;73:30-9. doi: 10.1016/j.visres.2012.09.002. Epub 2012 Sep 28. |
| 20220051 | Background | Smith EL 3rd, Hung LF, Huang J, Blasdel TL, Humbird TL, Bockhorst KH. Effects of optical defocus on refractive development in monkeys: evidence for local, regionally selective mechanisms. Invest Ophthalmol Vis Sci. 2010 Aug;51(8):3864-73. doi: 10.1167/iovs.09-4969. Epub 2010 Mar 10. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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