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| Name | Class |
|---|---|
| HOYA Lens Thailand LTD. | INDUSTRY |
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The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.
Optical interventions have been widely used for myopia control in children, however, the effectiveness varied between individuals. The current study spectacle lenses are modified based on DIMS technology.
Participants will be randomly allocated to single vision (SV) lens group (control), D1 or D2 group (treatment). The weekly choroidal thickness changes will be monitored in the first month of lens wear. Their cycloplegic refraction and axial length will be monitored every 6 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single vision lens group | No Intervention | Participants in single vision lens group will receive a pair of single vision lenses for 1 year after the short-term monitoring of choroidal thickness. | |
| D1 lens group | Experimental | Participants in D1 lens group will receive a pair of D1 lenses over 1 year after the short-term monitoring of choroidal thickness. |
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| D2 lens group | Experimental | Participants in D2 lens group will receive a pair of D2 lenses over 1 year after the short-term monitoring of choroidal thickness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Defocus Incorporated Multiple Segments lens (D1) | Other | D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously |
| Measure | Description | Time Frame |
|---|---|---|
| Choroidal thickness changes | Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period. | Baseline, every week for 1 month, every 6 months over 1 year |
| 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 1 year over the study period. | Baseline, 6 and 12 months |
| Axial length changes |
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Inclusion Criteria:
Hong Kong Chinese
Age at enrolment: 6 - 13 years
Myopia in spherical power: -1.00D to -5.00D in both eyes
Astigmatism: equal or less than 2.00D
The sum of spherical power and astigmatism: equal or less than -7.00D
Anisometropia (spherical equivalent refraction (SER)): equal or less than 1.50D
Previous myopia progression (valid documentation dated within 2 years before screening):
Best corrected visual acuity: LogMAR 0.04 or better in both eyes
Ocular health: no abnormalities in both internal and external ocular health
Binocular vision: no strabismus and other binocular abnormalities
Normal colour vision
Willing to wear the study spectacles all the time (10 hours per day, for 7 days per week)
Exclusion Criteria:
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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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Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.
| Modified Defocus Incorporated Multiple Segments lens (D2) | Other | D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously |
|
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 1 year over the study period. |
| Baseline, 6 and 12 months |