Effect of special lenses on controlling myopia in children
Myopia Control Effectiveness of Second-generation Defocus Incorporated Multiple Segments Spectacle Lenses on Fast Progressing Myopes: a Randomized Controlled Trial
This study is testing if special lenses can help slow down worsening eyesight in children who are getting more nearsighted quickly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hung Hom) |
| Trial ID | NCT05888792 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a new variant of Defocus Incorporated Multifocal Spectacle lenses (DG2) in controlling the progression of myopia in children who are fast progressors. Participants will be randomly assigned to either a control group wearing single vision lenses or a treatment group wearing the DG2 lenses. Over a period of two years, the study will monitor changes in refractive errors and axial length in both groups, with assessments every six months. The goal is to determine if the DG2 lenses can significantly slow down myopia progression compared to standard lenses.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 12 years with a documented history of fast progressing myopia.
Not a fit: Patients with strabismus, binocular vision abnormalities, or prior experience of myopia control may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective method for controlling myopia progression in children, potentially reducing the risk of severe vision problems later in life.
How similar studies have performed: Previous studies on myopia control using defocus incorporated lenses have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hung Hom
- School of Optometry, The Hong Kong Polytechnic University — Hung Hom, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Dennis Yan Yin Tse, PhD — School of Optometry, The Hong Kong Polytechnic University
- Study coordinator: Dennis Yan Yin Tse, PhD
- Email: dennis.tse@polyu.edu.hk
- Phone: 852-27666096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.