Myopia
Conditions
Keywords
Myopia, Defocus
Brief summary
The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) and a variant of DIMS (D2) spectacle lenses on controlling myopia progression in fast progressing myopic children.
Detailed description
DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time. Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over the first 2 years. They will then be prescribed with a pair of D2 spectacle lens for an additional 2 years. D2 is the variant of Defocus Incorporated Spectacle lenses. It is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.
Interventions
OTHERDIMS spectacle lens
DIMS spectacle lens is a multifocal 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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months. They will then be prescribed with a pair of D2 spectacle lenses for an additional 24 months.
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
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
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 over the 4-year study will be measured |
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 over the 4-year study will be measured |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORDennis Yan Yin Tse, PhD
School of Optometry, The Hong Kong Polytechnic University
Outcome results
None listed