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| Name | Class |
|---|---|
| HOYA Lens Thailand LTD. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single vision lens group | No Intervention | 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. | |
| D2 lens group | Experimental | Subjects in D2 lens group will receive a pair of D2 lenses over the 4-year study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Variant of Defocus Incorporated Spectacle lens (DG2) | Other | DG2 is a variant of Defocus Incorporated Spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously |
| 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 |
| 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 |
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Inclusion Criteria:
SER: -0.75D or below in both eyes
Documented history of fast progressing myopia, either in SER or AL
Best-corrected visual acuity (VA) in both eyes:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Yan Yin Tse, PhD | School of Optometry, The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry, The Hong Kong Polytechnic University | Hung Hom | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41171741 | Derived | 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. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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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.
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Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.