Myopia
Conditions
Keywords
Myopia, Children, Myopia control, Spectacle lenses
Brief summary
This study aims to evaluate the short-term efficacy and safety of a novel, proprietary spectacle lens. Forty myopic participants, aged 6 to 15 years, will be prescribed with the study spectacles for a period of six months. All subjects will be required to attend five scheduled visits. Change in subfoveal choroidal thickness (SfChT), axial length and refraction will be determined.
Detailed description
Optical strategies have been shown to be effective for slowing myopia progression. The design of the BLMCL patented spectacle lens is based on existing myopic control theory of peripheral defocus spectacle lenses. This prospective, observational cohort study aims to evaluate the short-term efficacy and safety of the BLMCL lens in school-aged children. Forty participants, aged 6 to 15 years with SER between -6.00D to -0.75D and astigmatism not more than -2.00D, will be fitted with the BLMCL Lens and followed for six months. They will be required to return for five scheduled visits: baseline, delivery, 1 month, 3 months, and 6 months after lens delivery visits. The primary endpoint is the change in subfoveal choroidal thickness (SfChT) for potential effective myopia control via SfChT thickening. The secondary endpoints are the changes in AL and refraction after cycloplegia which allow comparison with other myopia control studies. Subjective symptoms will be assessed using the PREP2 and QoV questionnaires.
Interventions
OTHERBCMC lens
BLMC spectacle lens is a spectacle lens that corrects the distance refraction and provides defocus in peripheral region
Sponsors
The Hong Kong Polytechnic University
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 6 to 15 years (Chinese), inclusive * Cycloplegic SER between -0.75 D and -6.00 D in both eyes * Astigmatism ≤ 2.00 D in both eyes * Anisometropia ≤ 1.50 D * BCVA of 0.04 logMAR or better in each eye
Exclusion criteria
* Previous or current use of any myopia control intervention within 6 months * Presence of any ocular pathology, amblyopia, colour vision deficiency or strabismus that could affect refractive development or visual function * History of ocular surgery or significant ocular trauma * Known systemic diseases or use of medications that could affect vision or ocular growth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in subfoveal choroidal thickness (SfChT) | Delivery and 1, 3, and 6 months after delivery | SfChT will be measured using Swept-Source OCT (SS-OCT) without cycloplegia. It will be measured at the delivery visit before dispensing, and 1, 3 and 6 months after delivery. In order to minimize the effect of diurnal variation, it will be measured within two hours hours from the first measurement at the delivery visit. Two good quality images will be captured for each eye. Segmentation of the images will be performed by a masked examiner. Changes in SfChT after using the lenses for 1, 3, and 6 months will be determined. |
Countries
Hong Kong
Outcome results
None listed