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

Not Applicable

Recruiting

• Conditions: Myopia
• Interventions: Other: Variant of Defocus Incorporated Spectacle lens (DG2)

• Registration Number: NCT05888792
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

The variant of Defocus Incorporated Spectacle lenses (DG2) 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 (DG2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the DG2 lens and be monitored for another 12 months. In parallel, the DG2 treatment groups will continue their corresponding intervention for 12 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years. The changes in refractive errors and axial length in two groups will be compared.

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Study Start: 2023-07-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-02-28
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DG2 lens group	Variant of Defocus Incorporated Spectacle lens (DG2)	Subjects in DG2 lens group will receive a pair of DG2 lenses over the 2-year study.

Primary Outcome Measures

Name	Time	Method
Cycloplegic refraction change in spherical equivalent refraction (SER)	Baseline, 1st year and 2nd year	Cycloplegic SER (in diopter) will be measured using an open field autorefractor.; Change in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured

Secondary Outcome Measures

Name	Time	Method
Axial length change	Baseline, 1st year and 2nd year	Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer.; Change in axial length from the baseline over a first 12-month period and a 12-month period of follow-up will be measured

Trial Locations

Locations (1)

School of Optometry, The Hong Kong Polytechnic University; 🇭🇰 Hung Hom, Hong Kong