Focus-out Glasses on Emmetropization in Chinese Children

Myopia Clinical Trial

Official title:

Effect of Peripheral Focus-out Glasses on Emmetropization in Chinese Children Aged 6-8 Years: 2 Years Randomized Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05689567
• Other study ID #: DEFOG
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Cycloplegic Objective Refraction(SER)(D)	Cycloplegic objective refraction (i.e reflected by SER) any follow-up time (only the right-eye data included). 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
Secondary	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
Secondary	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
Secondary	Axial Length (AL) (mm)	Axial Length (AL) at any follow-up 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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