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

NCT ID: NCT05888805

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-29

Study Completion Date

2026-05-31

Brief Summary

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The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Detailed Description

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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 2 years.

Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DIMS lens group

Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.

Group Type OTHER

DIMS spectacle lens

Intervention Type OTHER

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

Interventions

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DIMS spectacle lens

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

Intervention Type OTHER

Other Intervention Names

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MiYOSMART

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HOYA Lens Thailand LTD.

INDUSTRY

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Yan Yin Tse, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Optometry, The Hong Kong Polytechnic University

Locations

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School of Optometry, The Hong Kong Polytechnic University

Hung Hom, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Dennis Yan Yin Tse, PhD

Role: CONTACT

852-27666096

Rachel Ka Man Chun, PhD

Role: CONTACT

852-27664224

Facility Contacts

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Dennis Yan Yin Tse, PhD

Role: primary

852-27666096

Rachel Ka Man Chun, PhD

Role: backup

852-27664224

Other Identifiers

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P0043588

Identifier Type: -

Identifier Source: org_study_id

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