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| Name | Class |
|---|---|
| Eyebright Medical Technology (Beijing) Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single vision lens group | No Intervention | Participants in single vision contact lens group will receive single vision contact lenses for initial 12 months. They will switch to Lens A at 12-month mark for an additional 12 months. | |
| Lens A group | Experimental | Participants in Lens A group will receive Lens A contact lenses for 24 months. |
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| Lens B group | Experimental | Participants in Lens B group will receive Lens B contact lenses for 24 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A | Other | Lens A contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cycloplegic refraction change in spherical equivalent refraction (SER) | 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. | Baseline, 6, 12, 18 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length changes | 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. | Baseline, 6, 12, 18 and 24 months |
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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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Ka Man Chun, PhD | Contact | 852-27664224 | rachel.chun@polyu.edu.hk | |
| Dennis Yan Yin Tse, PhD | Contact | 852-27666096 | dennis.tse@polyu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Ka Man Chun, PhD | School of Optometry, The Hong Kong Polytechnic University | Principal Investigator |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C059215 | CRYAB protein, human |
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| Lens B | Other | Lens B contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus. |
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