Myopia
Conditions
Keywords
myopia
Brief summary
This is a clinical trial evaluating the wearability and effectiveness of three types of ZEISS spectacle lenses in controlling myopia progression. This study compares ZEISS MyoCare spectacle lenses with two types of single-vision spectacle lenses over a 6-month period. This trial aims to evaluate how well these lenses are worn and their impact on myopia progression, including changes in axial length and refractive error. Participants will be randomly assigned to wear one of three types of ZEISS spectacle lenses. The study will require five visits to the eye clinic over a 6-month period and two virtual follow-up visits.
Interventions
DEVICEZEISS MyoCare spectacle lenses
Spectacle lenses with conventional power profile including myopia control design.
DEVICEZEISS SV RX SPH 1.5
Commercially available single vision
DEVICEZEISS Clearview
Commercially available single vision
Sponsors
ZEISS Vision Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* be accompanied by a parent or guardian who is able to read and comprehend Vietnamese/English and sign a record of informed consent/assent; * at baseline, be within the age range of 7 to 13 years old inclusive; * be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D); * astigmatism ≤1.50D; * anisometropia of not more than 1.50D; * be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; * have ocular findings deemed to be normal; * vision correctable to at least 0.8 or better in each eye with spectacles.
Exclusion criteria
* Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; * Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. * Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial. NB: Systemic antihistamines are allowed on an as needed basis, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used. * History of eye trauma or eye surgery * Amblyopia * Anisometropia of not more than 1.50D * Strabismus * History of use of myopia control interventions such as Orthokeratology or atropine 3 months prior to commencement of this trial. * Known allergy or intolerance to ingredients to cycloplegic eye-drops. * Currently enrolled in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wearability | Day 1 At dispensing visit, 3 months and 6 months visits | Visual acuity with study spectacle lenses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myopia progression | At baseline and 6 months visits | The 6 monthly myopia progression measured by change in spherical equivalent from baseline for each of the study groups. |
Countries
Vietnam
Contacts
Primary ContactNicole Liu, MBBS, MOptom, PhD
Outcome results
None listed