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Focus-out Glasses on Emmetropization in Chinese Children

Primary Purpose

Emmetropization, Myopia, Hyperopia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DEFOG glasses(peripheral focus-out glasses)
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emmetropization

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Children's Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DEFOG group

Control group

Arm Description

Subjescts will wear DEFOG glasses(peripheral focus-out glasses).

Subjects in the control group will just be observed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Myopia
Cycloplegic SER≦-0.50D at any follow-up time. Objective refraction data will be examined by AUTO REF/KERATOMETER.
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.
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.
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.
Visual Acuity
The Logarithmic Visual Acuity at any follow-up time (only the right-eye data included).
Strabismus Examination(△)
Strabismus examination at any follow-up time by SYNOPTOPHORE.
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.
Pupil size(mm)
Pupil size at any follow-up time (only the right-eye data included).
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.

Full Information

First Posted
January 10, 2023
Last Updated
June 15, 2023
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05689567
Brief Title
Focus-out Glasses on Emmetropization in Chinese Children
Official Title
Effect of Peripheral Focus-out Glasses on Emmetropization in Chinese Children Aged 6-8 Years: 2 Years Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emmetropization, Myopia, Hyperopia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEFOG group
Arm Type
Experimental
Arm Description
Subjescts will wear DEFOG glasses(peripheral focus-out glasses).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects in the control group will just be observed.
Intervention Type
Device
Intervention Name(s)
DEFOG glasses(peripheral focus-out glasses)
Intervention Description
Subjects in the intervention group will wear peripheral focus-out glasses ≧8 hours a day and ≧5 days a week.
Primary Outcome Measure Information:
Title
Overall Changes of Cycloplegic Objective Refraction(spherical equivalent refraction, SER)(D)
Description
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
Secondary Outcome Measure Information:
Title
Changes of Cycloplegic Objective Refraction(SER) (D)
Description
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
Title
Cycloplegic Objective Refraction(SER)(D)
Description
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.
Time Frame
The 6th month, the 12th month, the 18th month and the 24th month from baseline
Title
Myopia
Description
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
Title
Changes of Axial Length(AL)(mm)
Description
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
Title
Axial Length (AL) (mm)
Description
Axial Length (AL) at any follow-up 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
Title
Amplitude of Accommodation (AMP)(D)
Description
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
Title
Visual Acuity
Description
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
Title
Strabismus Examination(△)
Description
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
Title
Changes of Choroidal Thickness (ChT) (um)
Description
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
Title
Pupil size(mm)
Description
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
Title
Peripheral Retinal Refraction(D)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenhao Yang
Phone
8618017590866
Email
ychben@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Shen
Phone
8613816362715
Email
pearlee52@hotmail.com
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201110
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Focus-out Glasses on Emmetropization in Chinese Children

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