Myopia
Conditions
Keywords
Myopia control, soft contact lenses
Brief 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.
Detailed description
This is a double-masked and randomized controlled trial. Participants will be randomly assigned to one of three interventions: two study contact lenses (CL)(Lens A or Lens B) or single vision (SVCL) for the initial 12 months. While the Lens A/B groups will continue their respective lenses, the participants initially assigned to the SVCL will cross over to Lens A at the 12-month mark. 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.
Interventions
Sponsors
The Hong Kong Polytechnic University
Eyebright Medical Technology (Beijing) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
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 * Agree to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 2-year study and to inform the study investigator if this schedule is interrupted. Wearing time may be modified by the study staff for health reasons * Agree to adhere to contact lens use requirements throughout study duration * Acceptance of the masked study design
Exclusion criteria
* Contraindications for soft contact lenses * Dry eye with drug intervention within 30 days * Regular use of ocular medication (prescription or over-the-counter), artificial tears, or wetting agents due to dryness, allergies or other conditions that hinder the contact lens wear * Current use of systemic medications that may significantly affect contact lens wear, tear film production, pupil size, accommodation, or refractive state. These include, but not limited to, long term use of nasal decongestants (e.g., pseudoephedrine, phenylephrine), antihistamines (e.g., chlorpheniramine, diphenhydramine, Prednisolone or Ritalin (methylphenidate) * Pre-existing systemic and ocular disease that had an influence on contact lens wearing * History of ocular injury or surgery * Prior use of myopic control interventions such as red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements * Allergy to cyclopentolate eye drops * Subjects who, in the judgment of the Investigator, are unable to cooperate and follow instructions during eye examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cycloplegic refraction change in spherical equivalent refraction (SER) | Baseline, 6, 12, 18 and 24 months | Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 2 years over the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial length changes | Baseline, 6, 12, 18 and 24 months | 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 2 year over the study period. |
Countries
Hong Kong
Contacts
CONTACTRachel Ka Man Chun, PhD
CONTACTDennis Yan Yin Tse, PhD
PRINCIPAL_INVESTIGATORRachel Ka Man Chun, PhD
School of Optometry, The Hong Kong Polytechnic University
Outcome results
None listed