Myopia Control Effectiveness of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Myopia

Treatments: Other: Variant of Defocus Incorporated Spectacle lens (DG2)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05888792

H-ZGET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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118 participants in 2 patient groups

Single vision lens group

No Intervention group

Description:

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.

DG2 lens group

Experimental group

Description:

Subjects in DG2 lens group will receive a pair of DG2 lenses over the 2-year study.

Treatment:

Other: Variant of Defocus Incorporated Spectacle lens (DG2)