Effect of Peripheral Focus-out Glasses on Emmetropization in Chinese Children Aged 6-8 Years: 2 Years Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Overall Changes of Cycloplegic Objective Refraction(spherical equivalent refraction, SER)(D)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: ≥6 and ≤8 years at enrollment.
- •At least one parent' s Spherical equivalent refraction≤-3.00D.
- •Spherical equivalent refractions (SERs) under cycloplegia: +0.50 to +1.50 diopters (D)
- •Astigmatism ≤1.00 D .
- •Anisometropia ≤1.00 D.
- •Best Corrected Visual Acuity (BCVA) : 1.0 or better
- •Provision of consent written by subject's legal guardian
- •Willing and able to participate in all required activities of the study
排除标准
- •Any of the following abnormalities on the ocular surface, such as trachoma, pemphigoid, chemical injury, heat burn, radiation injury, etc.
- •Eyelid abnormalities (e.g. entropion, ectropion, tumor, edema, blepharospasm, incomplete eyelid closure, severe trichiasis, severe ptosis) ,which affect eyelid function in either eye
- •Eye diseases such as strabismus, amblyopia, anisometropia, fundus diseases, and accommodation abnormality，etc.
- •Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, low-level red-light therapy, etc.
- •Noncompliance with measurement at enrollment.
研究组 & 干预措施
DEFOG group
Subjescts will wear DEFOG glasses(peripheral focus-out glasses).
干预措施: DEFOG glasses(peripheral focus-out glasses) (Device)
Control group
Subjects in the control group will just be observed.
结局指标
主要结局
Overall Changes of Cycloplegic Objective Refraction(spherical equivalent refraction, SER)(D)
时间窗: 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.
次要结局
- Changes of Axial Length(AL)(mm)(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- Amplitude of Accommodation (AMP)（D）(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- Changes of Cycloplegic Objective Refraction(SER) (D)(The 6th month, the 12th month and the 18th month from baseline)
- Strabismus Examination（△）(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- Pupil size（mm）(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- The percentage of participants with fast myopic shift(From baseline till the 24th month)
- Corneal curvature(D) or radius of curvature(mm)(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- Myopia(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- Changes of Choroidal Thickness (ChT) （um）(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- Peripheral Retinal Refraction(D)(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- Uncorrected Visual Acuity(The 6th month, the 12th month, the 18th month and the 24th month from baseline)
- Astigmatism (D)(The 6th month, the 12th month, the 18th month and the 24th month from baseline)