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

NCT05888805 | Active Not Recruiting DMC

• 1 other identifier: P0043588
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Keywords

Myopia; Defocus

Outcome Measures

Primary Outcomes (1)

• Cycloplegic refraction change in spherical equivalent refraction (SER)

  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 Outcomes (1)

• Axial length change

  Baseline, every 6 months for 4 years

Study Arms (1)

DIMS to D2 lens group

OTHER

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

Interventions

DIMS spectacle lens OTHER

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

Also known as: MiYOSMART

DIMS to D2 lens group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• HOYA Lens Thailand LTD.: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Location

Related Publications (1)

• Hon Y, Chun RKM, Leung TW, Qi H, Hasegawa K, Leung KY, To CH, Lam CSY, Tse DY. Myopia control efficacy of second-generation defocus incorporated multiple segments spectacle lenses on fast progressing myopes: Study protocol of a randomised controlled trial. PLoS One. 2025 Oct 31;20(10):e0335061. doi: 10.1371/journal.pone.0335061. eCollection 2025.

  PMID: 41171741 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Dennis Yan Yin Tse, PhD

  School of Optometry, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months. They will then be prescribed with a pair of D2 spectacle lenses for an additional 24 months.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: July 29, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)