Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes
NCT ID: NCT05888792
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2023-07-29
2026-05-31
Brief Summary
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Detailed Description
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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 12 months. In parallel, the D2 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Single vision lens group
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 the second year of the study.
No interventions assigned to this group
D2 lens group
Subjects in D2 lens group will receive a pair of D2 lenses over the 2-year study.
Variant 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
Interventions
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Variant 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
Eligibility Criteria
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Inclusion Criteria
* 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
* Ocular and systemic abnormalities
* Prior experience of myopia control
4 Years
12 Years
ALL
Yes
Sponsors
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HOYA Lens Thailand LTD.
INDUSTRY
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Principal Investigators
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Dennis Yan Yin Tse, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Optometry, The Hong Kong Polytechnic University
Locations
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School of Optometry, The Hong Kong Polytechnic University
Hung Hom, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-ZGET
Identifier Type: -
Identifier Source: org_study_id
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