Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes - Auxiliary Group

April 17, 2026 updated by: The Hong Kong Polytechnic University
The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) and a variant of DIMS (D2) spectacle lenses on controlling myopia progression in fast progressing myopic children.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over the first 2 years. They will then be prescribed with a pair of D2 spectacle lens for an additional 2 years. D2 is the variant of Defocus Incorporated Spectacle lenses. It is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Study Type

Interventional

Enrollment (Estimated)

59

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 Locations

  • Hong Kong
      • Hung Hom, Hong Kong
        • School of Optometry, The Hong Kong Polytechnic University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • SER: -1.00D or below
  • Documented history of fast progressing myopia, either in SER or AL
  • SER progression: 0.50D/year or more
  • AL elongation: 0.27mm/year or more
  • Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better
  • Acceptance of random group allocation and the masked study design
  • Anisometropia of 1.50 D or less
  • Astigmatism of 2.00 D or less

Exclusion Criteria:

  • Strabismus and binocular vision abnormalities
  • Ocular and systemic abnormalities
  • Prior experience of myopia control

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DIMS to D2 lens group
Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months. They will then wear a pair of D2 spectacle lenses for an additional 24 months.
Other: DIMS spectacle lens
DIMS spectacle lens is a multifocal spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously.
Other Names:
  • MiYOSMART

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycloplegic refraction change in spherical equivalent refraction (SER)
Time Frame: Baseline, every 6 months for 4 years

Cycloplegic SER (in diopter) will be measured using an open field autorefractor.

Change in SER with cycloplegia from the baseline every 6 months over the 4-year study will be measured
Baseline, every 6 months for 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length change
Time Frame: Baseline, every 6 months for 4 years

Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer.

Change in axial length from the baseline every 6 months over the 4-year study will be measured
Baseline, every 6 months for 4 years

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Collaborators

HOYA Lens Thailand LTD.

Investigators

  • Principal Investigator: Dennis Yan Yin Tse, PhD, School of Optometry, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 29, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0043588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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