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

Myopia Control Effectiveness of Second-generation Defocus Incorporated Multiple Segments Spectacle Lenses on Fast Progressing Myopes: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Other: Variant of Defocus Incorporated Spectacle lens (DG2)

Detailed Description

The variant of Defocus Incorporated Spectacle lenses (D2) is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be randomly allocated to either single vision lens group (control) or the variant of Defocus Incorporated Spectacle lens (D2) group (treatment). After 12 months of lens wear, 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 another 36 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 4 years. The changes in refractive errors and axial length in two groups will be compared.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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,
  • 4-5 years old: myopia of -0.75D or below in both eyes
  • 6 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:

  • 4 - 6 years old: 0.20 logMAR (or its equivalent) or better
  • 7-12 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Single vision lens group; 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.
Experimental: D2 lens group; 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); DG2 is a variant of Defocus Incorporated Spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length change	Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 4 years over the study period.	Baseline, every 6 months for 4 years

Collaborators and Investigators

• 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

General Publications

• 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.

Study record dates

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: Myopia; Defocus
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: H-ZGET

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