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OpenTrials
Active, not recruiting

NCT Number: NCT05888805

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry, The Hong Kong Polytechnic University

Hung Hom, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DIMS spectacle lens

Other

DIMS spectacle lens is a multifocal spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously.

Other names: MiYOSMART

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • HOYA Lens Thailand LTD.

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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