Overview
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.
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.
Eligibility
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