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The purpose of this study is to characterize the effects of peripheral focous-out glasses on emmetropization in non-myopic Chinese Children Aged 6-8 Years.This is a prospective, parallel-controlled randomized trial.
Myopia is one of the most common eye diseases that cause visual impairment and blindness, and the high rate of myopia in young people is a major public health issue. Based on the clinical studies of optical defocusing to regulate eye growth and refractive changes through visual signal feedback, we hypothesize that early wearing of peripheral defocus glasses in children can slow down the process of emmetropization and even prevent the onset of myopia by producing more myopic defocusing. The aim of this study is to investigate whether wearing peripheral defocus glasses can effectively delay emmetropization in non-myopic children aged 6-8 years , and to further explore its effect on preventing the onset of myopia.
The study adopts a 2-year，single-centre, randomized, parallel-controlled trial with a non-blinded design. Subjects who pass the screening period will have their baseline data collected and will be assigned to the experimental or control groups according to the randomization principle. The experimental group will be fitted with Direct Emmetropia with Focus-out Glasses (hereafter referred to as DEFOG) to guide the emmetropization process. The control group will be given no treatment and will be a blank control. Baseline data including visual acuity, cycloplegic objective refraction, axis length, accommodation amplitude, strabismus examination, pupil size, choroidal thickness and peripheral retinal refraction will be measured when enrolled in the group and follow-up data will be measured at month 6, 12, 18 and 24. The primary interest of this study will be studied by comparing the difference in cycloplegic objective refraction changes between month 24 and baseline in the two groups of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEFOG group | Experimental | Subjescts will wear DEFOG glasses(peripheral focus-out glasses). |
|
| Control group | No Intervention | Subjects in the control group will just be observed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEFOG glasses(peripheral focus-out glasses) | Device | Subjects in the intervention group will wear peripheral focus-out glasses ≧8 hours a day and ≧5 days a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Changes of Cycloplegic Objective Refraction(spherical equivalent refraction, SER)(D) | Changes of cycloplegic objective refraction(i.e reflected by SER) from baseline till the 24th month (only the right-eye data included). Objective refraction data will be examined by AUTO REF/KERATOMETER. Ciliary muscle paralysis will be performed by using 1% cyclopentanone eye drops, 2 doses in each eye, 2 doses 5 minutes apart. The optometry will be performed after 20 minutes of complete ciliary muscle paralysis (disappearance of pupil response to light or pupil diameter at least greater than 6 mm). SER is calculated by adding the sum of the sphere power with half of the cylinder power. Baseline data will be measured at the time of enrollment. Follow-up data will be measured on the 24th month from baseline. The 24th month data will be subtracted from the baseline data to obtain changes. | From baseline till the 24th month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Cycloplegic Objective Refraction(SER) (D) | Changes of cycloplegic objective refraction (i.e reflected by SER) different follow-up time and the baseline time (only the right-eye data included). Objective refraction data will be examined by AUTO REF/KERATOMETER. | The 6th month, the 12th month and the 18th month from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201110 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37993963 | Derived | Shen L, He W, Yang W, Yan W, Yang C. Effect of wearing peripheral focus-out glasses on emmetropization in Chinese children aged 6-8 years: study protocol for a 2-year randomized controlled intervention trial. Trials. 2023 Nov 22;24(1):746. doi: 10.1186/s13063-023-07799-8. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2026 | Feb 20, 2026 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Myopia |
Cycloplegic SER≦-0.50D at any follow-up time. Objective refraction data will be examined by AUTO REF/KERATOMETER. |
| The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| Changes of Axial Length(AL)(mm) | Changes of Axial Length (AL) between different follow-up time and the baseline time (only the right-eye data included).AL will be examined by IOL Master. | The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| Amplitude of Accommodation (AMP)（D） | Amplitude of Accommodation (AMP) at any follow-up time (only the right-eye data included). AMP will be examined by lens test. | The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| Uncorrected Visual Acuity | The Logarithmic Visual Acuity at any follow-up time (only the right-eye data included). | The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| Strabismus Examination（△） | Strabismus examination at any follow-up time by SYNOPTOPHORE. | The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| Changes of Choroidal Thickness (ChT) （um） | Changes of Choroidal Thickness (ChT)between different follow-up time and the baseline time (only the right-eye data included). ChT will be examined by OPTICALCOHERENCETOMOGRAPHY. | The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| Pupil size（mm） | Pupil size at any follow-up time (only the right-eye data included). | The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| Peripheral Retinal Refraction(D) | Peripheral Retinal Refraction at any follow-up time (only the right-eye data included). Peripheral Retinal Refraction will be examined by AUTO FUNDUS CAMERA. | The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| The percentage of participants with fast myopic shift | The percentage of participants with fast myopic shift over 2 years(only the right-eye data included). The fast myopic shift is defined as cycloplegic objective refraction (i.e reflected by SER) myopic shift of at least 1.00 D. Objective refraction data will be examined by AUTO REF/KERATOMETER. | From baseline till the 24th month |
| Corneal curvature(D) or radius of curvature(mm) | Corneal curvature or radius of curvature(only the right-eye included). They can be interconverted. Data will be examined by AUTO REF/KERATOMETER. | The 6th month, the 12th month, the 18th month and the 24th month from baseline |
| Astigmatism (D) | The adtigmatism at any follow-up time (only the right-eye data included). | The 6th month, the 12th month, the 18th month and the 24th month from baseline |