A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Wearability and Myopia Progression of ZEISS MyoCare Spectacle Lenses Versus Two ZEISS Single Vision Spectacle Lenses in Children With Myopia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Wearability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 13 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
SV 1
Single vision lenses
Intervention: ZEISS SV RX SPH 1.5 (Device)
SV 2
Single vision lenses
Intervention: ZEISS Clearview (Device)
MyoCare
ZEISS MyoCare spectacle lenses
Intervention: ZEISS MyoCare spectacle lenses (Device)
Outcomes
Primary Outcomes
Wearability
Time Frame: At 1-week, 2-week, 3 months and 6 months visits
Compliance (lens wearing time, hr/day) to study spectacle lenses wear
Wearability
Time Frame: Day 1 At dispensing visit, 3 months and 6 months visits
Visual acuity with study spectacle lenses
Wearability
Time Frame: Day 1 At dispensing visit, 1-week and 2-week visits, and 3 months and 6 months visits
Subjective responses measured by a wearability questionnaire (scale 1-10, with 1 being the worst and 10 being the best) regarding study spectacle lenses wear
Secondary Outcomes
- Myopia progression(At baseline, 3 months, and 6 months visits)
- Myopia progression(At baseline and 6 months visits)