Management of Myopia in University Students Using Dual Focus Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Change in axial length relative to baseline
研究概览
简要总结
The purpose of the study is to quantify the effectiveness of Coopervision MiSight contact lenses in slowing the rate of myopia progression in university students.
详细描述
MiSight contact lenses have been shown to be a safe and effective way of managing myopia progression in children aged 8-12 years. However, myopic progression is not limited to children of this age group and MiSight lenses have also been shown to be effective in older children aged 11-16 years. There is evidence that progression also occurs in university students. The researchers are therefore investigating the effectiveness of this intervention in a group of UK-based University students.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a myopic students studying at university
- •Be aged 18-21 years at the start of the study
- •Show evidence of recent myopia progression prior to commencement of Stage 2 of the study.
- •Have read the patient information sheet and be happy to sign the consent forms
- •Be willing to adhere to the visit schedule and wearing times described in this protocol
- •Agree to lens wearing times of at least 10 hours per day, 6 days per week
- •Agree to accept either the control or test lens as assigned by the randomisation
- •Have BCVA of +0.10 logMAR or better in each eye
排除标准
- •Previous myopia control use (optical or pharmacological)
- •Amblyopia
- •Ocular pathology such as keratoconus or recurrent corneal infections
- •Myopic Rx > 10D
- •Astigmatism >1D
- •Anisometropia >1.75D
- •Binocular Vision anomalies (such as Tropia)
- •Medications that affect pupil size or accommodation
- •A known allergy to fluorescein or tropicamide
- •Biomicroscopic findings that would contraindicate contact lens wear
- •The investigator considers that it is not in the best interest of the subject to participate in the study.
研究组 & 干预措施
MiSight dual focus contact lens
干预措施: MiSight contact lenses (Device)
Proclear single vision contact lens
干预措施: Proclear contact lenses (Device)
结局指标
主要结局
Change in axial length relative to baseline
时间窗: Baseline, 24 months
Change in spherical equivalent cycloplegic autorefraction relative to baseline
时间窗: Baseline, 24 months
次要结局
未报告次要终点