EmmetropizationNCT05689567
Focus-out Glasses on Emmetropization in Chinese Children
A study testing DEFOG glasses(peripheral focus-out glasses) in people with Emmetropization and Myopia, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Emmetropization, Myopia, Hyperopia
- What is being tested?
- DEFOG glasses(peripheral focus-out glasses)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201110
About this study
Official title: Effect of Peripheral Focus-out Glasses on Emmetropization in Chinese Children Aged 6-8 Years: 2 Years Randomized Clinical Trial.
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.
Read the detailed description
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.
- Conditions
- Emmetropization, Myopia, Hyperopia
- Being tested
- DEFOG glasses(peripheral focus-out glasses)
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| DEFOG group | Experimental | Subjescts will wear DEFOG glasses(peripheral focus-out glasses). Receives: Device: DEFOG glasses(peripheral focus-out glasses) |
| Control group | No intervention | Subjects in the control group will just be observed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline till the 24th month
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start23 Mar 2023
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmmetropizationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689567
- Sponsor's protocol ID
- DEFOG
- Status last verified
- Oct 2026
- First submitted
- 10 Jan 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37993963
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peripheral Focus-out Glasses on Emmetropization in Chinese Children Aged 6-8 Years: 2 Years Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05689567
- Acronym / sponsor ID
- DEFOG
- Conditions
- Emmetropization, Myopia, Hyperopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEFOG group | Experimental | Device: DEFOG glasses(peripheral focus-out glasses)Subjescts will wear DEFOG glasses(peripheral focus-out glasses). |
| Control group | No intervention | –Subjects in the control group will just be observed. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | DEFOG group |
Primary outcome
Overall Changes of Cycloplegic Objective Refraction(spherical equivalent refraction, SER)(D)
Time frame: 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.
12 secondary outcomes
Changes of Cycloplegic Objective Refraction(SER) (D)
Time frame: The 6th month, the 12th month and the 18th month from baseline
Myopia
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Changes of Axial Length(AL)(mm)
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Amplitude of Accommodation (AMP)（D）
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Uncorrected Visual Acuity
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Strabismus Examination（△）
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Changes of Choroidal Thickness (ChT) （um）
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Pupil size（mm）
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Peripheral Retinal Refraction(D)
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
Time frame: From baseline till the 24th month
Corneal curvature(D) or radius of curvature(mm)
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Astigmatism (D)
Time frame: The 6th month, the 12th month, the 18th month and the 24th month from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 37993963Shen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEFOG glasses(peripheral focus-out glasses) in people with Emmetropization and Myopia, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Changes of Cycloplegic Objective Refraction(spherical equivalent refraction, SER)(D) (time frame: From baseline till the 24th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.