NCT06821074

Brief Summary

The purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (DIMS) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Feb 2025Feb 2027

Study Start

First participant enrolled

February 8, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

February 10, 2025

Last Update Submit

April 22, 2025

Conditions

Myopia

Keywords

myopiaVisual Function TrainingDefocus-Enhanced SpectaclesSingle Vision Spectacles

Outcome Measures

Primary Outcomes (1)

  • Change in spherical equivalent 12 months after the commencement of training.

    Change in spherical equivalent 12 months after the commencement of training.

    Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.

Secondary Outcomes (1)

  • Change in axial length 12 months after the commencement of training.

    Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.

Study Arms (2)

Defocus-enhanced spectacles

EXPERIMENTAL

Vision function training while wearing defocus-enhanced spectacles

Single vision spectacles

PLACEBO COMPARATOR

Vision function training while wearing single vision spectacles

Device: Single vision spectacles

Interventions

Defocus-enhanced spectaclesDEVICE

Vision function training while wearing defocus-enhanced spectacles

Single vision spectaclesDEVICE

Vision function training while wearing single vision spectacles

Single vision spectacles

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 6-18 years.
  • Diagnosed myopia with SER between -0.50D and -4.00D.
  • Astigmatism ≤ 2.50DC.
  • Anisometropia \< 1.25D.

You may not qualify if:

  • Suspected genetic syndromes (e.g., Stickler, Marfan).
  • Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
  • Myopia progression \<0.50D SER in the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing New Vision Eye Hospital

Beijing, 100020, China

RECRUITING

Beijing Visionly Plus Eye Hospital

Beijing, 1000274, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Lin Yang, M.D.

CONTACT

+86-17898805125roc001cn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 11, 2025

Study Start

February 8, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Only IPD used in the results publication will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
February 2025-February 2027

Locations

CN(2)