Myopia Control Using Novel Soft Contact Lenses (NCT07547085) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Myopia Control Using Novel Soft Contact Lenses
126 participantsStarted 2026-04-16
Plain-language summary
The goal of this study is to investigate the myopic control efficacy of two study soft contact lenses in children. Participants will be prescribed Lens A, Lens B or single vision contact lenses for the first year. Participants in single vision contact lenses group will switch to Lens A at 12 months. All participants will then continue lens wear for an additional 12 months. Their cycloplegic refraction and axial length will be monitored every 6 months for 2 years.
Who can participate
Age range7 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Age at enrolment: 7 - 12 (both inclusive) years old Hong Kong Chinese schoolchildren
* Refractive errors in terms of spherical equivalent refraction (SER) determined by cycloplegic autorefraction: -0.75 diopters (D) to -5.00D in both eyes
* Astigmatism: equal or less than -1.00D
* Anisometropia: equal or less than -1.75D
* Previous myopia progression:
* -0.50D (in SER) per year or more in 1 eye or both eyes OR Axial length elongation: 0.27mm/year in 1 eye or both eyes
* If myopia is initially detected during screening, eligibility requires an SER below the 3rd percentile curve of refraction in either or both eyes (4)
* Best corrected visual acuity: better than 0.04 LogMAR in both eyes
* Ocular health: no abnormalities in both internal and external ocular health
* Systemic health: no systemic interference with ocular vision functioning
* Binocular vision: no strabismus and other binocular abnormalities
* No medication or supplements that affect eye growth
* Normal colour vision
* No previous use of myopic control interventions such as red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control
* Agree to maintain the visit schedule and be able to keep all appointments as specified in the informed assent and consent forms throughout study duration.
* Agree to accept either the control or study lens as assigned by the randomization scheme
* Agr…
What they're measuring
1
Cycloplegic refraction change in spherical equivalent refraction (SER)