About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Parallel
Treatments tested in this trial
Modified Defocus Incorporated Multiple Segments lens (D1)
Other interventionD1 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 interventionD2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
Treatment groups
Trial outcomes
Primary outcomes
Choroidal thickness changes
Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period.
Secondary outcomes
Cycloplegic refraction change in spherical equivalent refraction (SER)
Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 1 year over the study period.
Axial length changes
Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 1 year over the study period.
Sponsors and contacts
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The Hong Kong Polytechnic University
Lead sponsor
HOYA Lens Thailand LTD.
Collaborator