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RECRUITING Not applicable ClinicalTrials.gov

Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses

Sponsor: The Hong Kong Polytechnic University • ClinicalTrials.gov ID: NCT07547072

Registry updated: 2026-09-17
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Description

The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.

Interventions

  • Modified Defocus Incorporated Multiple Segments lens (D1) (Other)
    D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
  • Modified Defocus Incorporated Multiple Segments lens (D2) (Other)
    D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously

Eligibility criteria

Inclusion Criteria: * Hong Kong Chinese * Age at enrolment: 6 - 13 years * Myopia in spherical power: -1.00D to -5.00D in both eyes * Astigmatism: equal or less than 2.00D * The sum of spherical power and astigmatism: equal or less than -7.00D * Anisometropia (spherical equivalent refraction (SER)): equal or less than 1.50D * Previous myopia progression (valid documentation dated within 2 years before screening): * -0.50D (SER) per year or more in both eyes OR Axial length elongation: 0.27mm/year in both eyes * If myopia is initially detected during screening, eligibility requires myopia (in SER) below the 3rd percentile curve of refraction in both eyes.12 * Best corrected visual acuity: LogMAR 0.04 or better in both eyes * Ocular health: no abnormalities in both internal and external ocular health * Binocular vision: no strabismus and other binocular abnormalities * Normal colour vision * Willing to wear the study spectacles all the time (10 hours per day, for 7 days per week) Exclusion Criteria: * Previous or current treatment for myopia control (e.g., red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control) * Existing or past eye diseases or surgeries (e.g., strabismus surgery, amblyopia, oculomotor nerve palsies, corneal disease, intraocular disease, etc.) that may have an impact on vision or visual development * Long-term medication (intake at least 3 days/week) or medication/supplements that affect eye health * Systemic diseases that may have an impact on vision or visual development (e.g., endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.) * Allergic to cyclopentolate eye drops * Individuals who, in the judgment of the Investigator, are unable to cooperate and follow instructions during eye examination.

Conditions

Myopia

Locations

  • Optometry Research Clinic, School of Optometry, The Hong Kong Polytechnic University — Kowloon, Hong Kong, Hong Kong
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record