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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Spectacle lenses with conventional power profile including myopia control design.
Commercially available single vision
Commercially available single vision
Hanoi Eye Hospital 2
Hanoi, Vietnam
RECRUITINGWearability
Visual acuity with study spectacle lenses
Time frame: Day 1 At dispensing visit, 3 months and 6 months visits
Wearability
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
Time frame: Day 1 At dispensing visit, 1-week and 2-week visits, and 3 months and 6 months visits
Wearability
Compliance (lens wearing time, hr/day) to study spectacle lenses wear
Time frame: At 1-week, 2-week, 3 months and 6 months visits
Myopia progression
The 6 monthly myopia progression measured by change in spherical equivalent from baseline for each of the study groups.
Time frame: At baseline and 6 months visits
Myopia progression
The 6 monthly myopia progression measured by change in axial length from baseline for each of the study groups.
Time frame: At baseline, 3 months, and 6 months visits
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