NCT05689567

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

January 10, 2023

Last Update Submit

February 20, 2026

Conditions

EmmetropizationMyopiaHyperopia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Changes of Cycloplegic Objective Refraction(SER) (D)

    The 6th month, the 12th month and the 18th month from baseline

  • Myopia

    The 6th month, the 12th month, the 18th month and the 24th month from baseline

  • 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

  • Uncorrected Visual Acuity

    The 6th month, the 12th month, the 18th month and the 24th month from baseline

  • +7 more secondary outcomes

Study Arms (2)

DEFOG group

EXPERIMENTAL

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

Device: DEFOG glasses(peripheral focus-out glasses)

Control group

NO INTERVENTION

Subjects in the control group will just be observed.

Interventions

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.

DEFOG group

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201110, China

Location

Related Publications (1)

  • 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.

    PMID: 37993963DERIVED

MeSH Terms

Conditions

MyopiaHyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

March 23, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)