DEFOG glasses(peripheral focus-out glasses): Subjects in the intervention group will wear peripheral focus-out glasses ≧8 hours a day and ≧5 days a week.
Study summary
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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
8 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age: ≥6 and ≤8 years at enrollment.
2. At least one parent' s Spherical equivalent refraction≤-3.00D.
3. Spherical equivalent refractions (SERs) under cycloplegia: +0.50 to +1.50 diopters (D)
4. Astigmatism ≤1.00 D .
5. Anisometropia ≤1.00 D.
6. Best Corrected Visual Acuity (BCVA) : 1.0 or better
7. Provision of consent written by subject's legal guardian
8. Willing and able to participate in all required activities of the study
Exclusion Criteria:
1. Any of the following abnormalities on the ocular surface, such as trachoma, pemphigoid, chemical injury, heat burn, radiation injury, etc.
2. Eyelid abnormalities (e.g. entropion, ectropion, tumor, edema, blepharospasm, incomplete eyelid closure, severe trichiasis, severe ptosis) ,which affect eyelid function in either eye
3. Eye diseases such as strabismus, amblyopia, anisometropia, fundus diseases, and accommodation abnormality，etc.
4. Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, low-level red-light therapy, etc.
5. Noncompliance with measurement at enrollment.
Primary outcome measure(s)
Overall Changes of Cycloplegic Objective Refraction(spherical equivalent refraction, SER)(D) — From baseline till the 24th month 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.
Trial sites (1)
Facility
City
Region
Status
Children's Hospital of Fudan University
Shanghai
Shanghai Municipality
More Children's Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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