An interventional study of DEFOG glasses(peripheral focus-out glasses) in Emmetropization, Myopia and Hyperopia, sponsored by Children's Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Prevention
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 160 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
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Exclusion Criteria:
Subjescts will wear DEFOG glasses(peripheral focus-out glasses).
Device: DEFOG glasses(peripheral focus-out glasses)
Subjects in the control group will just be observed.
Subjects in the intervention group will wear peripheral focus-out glasses ≧8 hours a day and ≧5 days a week.
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.
Time frame: From baseline till the 24th month
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.
Time frame: The 6th month, the 12th month and the 18th month from baseline
Myopia
Cycloplegic SER≦-0.50D at any follow-up time. Objective refraction data will be examined by AUTO REF/KERATOMETER.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2023 to primary completion in Apr 2026, 36 months.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 36 months is above that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Mar 2026 → Apr 2026 and completion Mar 2026 → Apr 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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