Myopia
Conditions
Keywords
Myopia, Defocus
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 (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.
Interventions
OTHERVariant 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
Sponsors
The Hong Kong Polytechnic University
HOYA Lens Thailand LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cycloplegic refraction change in spherical equivalent refraction (SER) | Baseline, every 6 months for 4 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial length change | Baseline, every 6 months for 4 years | 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. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORDennis Yan Yin Tse, PhD
School of Optometry, The Hong Kong Polytechnic University
Outcome results
None listed