A Pilot Study on the Short-Term Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in subfoveal choroidal thickness (SfChT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BLMC lenses
Participants will be prescribed with a pair of study spectacle lenses for six months
干预措施: BCMC lens (Other)
结局指标
主要结局
Change in subfoveal choroidal thickness (SfChT)
时间窗: 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.
次要结局
未报告次要终点
研究者
LAM Chuen Thomas, FAAO, PhD
Professor
The Hong Kong Polytechnic University