Shamir Aspheric Ophthalmic Lenses (MyLens) for Myopic Control Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Changes in axial length in 6-12 months
研究概览
简要总结
The aim of this clinical trial is to compare the rate of myopic progression in children wearing aspheric (MyLens) and spherical/ toric ophthalmic lenses. The proposed lens design is an aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information). Myopic progression is quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 6-12 months (6 months crossover) with double-masking. Peripheral refraction and ocular aberration will be evaluated.
详细描述
Visual manipulation induced by progressive addition lenses (PALs) have been shown to inhibit eye growth and myopia development in children with up to 11% to 21% efficacy compared to single vision lenses. However, the treatment effect of PALs is statistically significant but clinically insufficient. The current study aims at investigating the use of spectacle lenses with a unique novel design for myopia control in children. This prospective one-year randomized clinical study will evaluate axial elongation and myopia progression in eyes using the novel lens design compared to those using the conventional single-vision design. It is a double-masked, cross-over study. One eye will be fitted with the study lens and the other eye will be fitted with the single-vision lens. Subjects will be asked to wear the spectacles for 6 months and the two lens designs will be swapped in the next 6 months after a wash-out period of 2 weeks. Both the subjects and examiners will not aware the lens design being used by the subjects in each phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Myopia between 0.75 ~ - 4.50 D and with-the-rule astigmatism not more than 1.50 D
- •Difference between eyes, no more than 1.25 spherical equivalent
- •Best corrected visual acuity (VA) is equal to or better than 0.10 in logMAR scale (Snellen VA 6/7.5 or better)
- •Eyes straight at distance and near with best subjective correction
- •Willing to be randomized and wear the study spectacles according to the instructions from practitioner
- •Willing to come back for follow up in the Optometry Clinic during the study period
排除标准
- •Abnormal ocular and general health
- •Prior myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
- •History of rigid contact lenses (including orthokeratology lenses) wearing
- •Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
- •Ocular conditions which might affect the refractive error (for example, cataract, ptosis).
研究组 & 干预措施
Aspheric lens
An aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information)
干预措施: Aspheric lens (Device)
Single vision spheric/toric lenses
Control: single vision spheric/toric lenses
结局指标
主要结局
Changes in axial length in 6-12 months
时间窗: Every 6 months for a period of 1 year
Evaluate the changes in cycloplegic axial length in the eye with aspheric lens (MyLens) compared to the other eye with single vision spheric/toric lens
次要结局
未报告次要终点
研究者
Pauline Cho
Professor
The Hong Kong Polytechnic University