Defocus-Enhanced vs. Single Vision Spectacles in Myopia Control Visual Function Training

April 22, 2025 updated by: Beijing Visionly Plus Eye Hospital

Comparative Study of Visual Function Training With Defocus-Enhanced Spectacles vs. Single Vision Spectacles on Myopia Control in Children

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100020
        • Recruiting
        • Beijing New Vision Eye Hospital
        • Contact:
      • Beijing, China, 1000274
        • Recruiting
        • Beijing Visionly Plus Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Defocus-enhanced spectacles
Vision function training while wearing defocus-enhanced spectacles
Device: Defocus-enhanced spectacles
Vision function training while wearing defocus-enhanced spectacles
Placebo Comparator: Single vision spectacles
Vision function training while wearing single vision spectacles
Device: Single vision spectacles
Vision function training while wearing single vision spectacles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in spherical equivalent 12 months after the commencement of training.
Time Frame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in axial length 12 months after the commencement of training.
Time Frame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Visionly Plus Eye Hospital

Collaborators

High Myopia Control Alliance (HIMALAYA)
Beijing New Vision Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Himalaya202502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only IPD used in the results publication will be shared

IPD Sharing Time Frame

February 2025-February 2027

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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