Clinical trial NCT05888792: Myopia Control Effectiveness of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes
Official title: Myopia Control Effectiveness of Second-generation Defocus Incorporated Multiple Segments Spectacle Lenses on Fast Progressing Myopes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Myopia
Defocus
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: HOYA Lens Thailand LTD.
First posted: 2023-06-05
Enrollment: 118
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly allocated to either control (wearing single vision lenses) group or treatment (DG2 lens) group for first 12 months. After 12 months, 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.
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Cycloplegic refraction change in spherical equivalent refraction (SER)
timeFrame: Baseline, 1st year and 2nd year
Secondary outcomes:
measure: Axial length change
timeFrame: Baseline, 1st year and 2nd year
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Optometry, The Hong Kong Polytechnic University
Study officials:
affiliation: School of Optometry, The Hong Kong Polytechnic University
name: Dennis Yan Yin Tse, PhD
role: PRINCIPAL_INVESTIGATOR
References: