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

NCT05888792 | Active Not Recruiting DMC

• 1 other identifier: H-ZGET
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated 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 for 4 years over the study period.

  Baseline, every 6 months for 4 years

Secondary Outcomes (1)

• Axial length change

  Baseline, every 6 months for 4 years

Study Arms (2)

Single vision lens group

NO INTERVENTION

Subjects in single vision lens group will receive a pair of single vision lenses for the first year of study. They will then receive a pair of DG2 lenses for an additional 3 years.

D2 lens group

EXPERIMENTAL

Subjects in D2 lens group will receive a pair of D2 lenses over the 4-year study.

Other: Variant of Defocus Incorporated Spectacle lens (DG2)

Interventions

Variant of Defocus Incorporated Spectacle lens (DG2) OTHER

DG2 is a variant of Defocus Incorporated Spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously

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: -0.75D or below in both eyes
• 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
• For children aged 4-6 years without past prescription forms,
• years old: myopia of -0.75D or below in both eyes
• years old: myopia of -1.25D or below in at least one eye, with the other eye -0.75D or below
• Best-corrected visual acuity (VA) in both eyes:
• years old: 0.20 logMAR (or its equivalent) or better
• years old: 0.00 logMAR (or its 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to either control (wearing single vision lenses) group or treatment (D2 lens) group for first 12 months. After 12 months, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 36 months. In parallel, the D2 treatment groups will continue their corresponding intervention for 36 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)