Management of Myopia in University Students Using Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Axial length
研究概览
简要总结
The purpose of the study is to quantify the effectiveness of Hoya MiyoSmart IQ (DIMS-TED) spectacle lenses in slowing the rate of myopia progression in university students.
详细描述
MiyoSmart spectacle 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 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
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 23 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopic students studying at university
- •Aged 18-23 years at the start of the study
- •Show evidence of axial length growth of at least 0.06mm prior to entry into 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 the protocol
- •Agree to accept either the control or test lenses 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
- •Myopic Rx up to -10D
- •Astigmatism up to 4D
- •Anisometropia <1.75D
- •Binocular Vision anomalies (such as tropia)
- •Taking medications that affect pupil size or accommodation
- •A known allergy to tropicamide
研究组 & 干预措施
Experimental: DIMS TED scpectacle lenses
Active Comparator: Single vision spectacle lenses
干预措施: DIMS TED spectacle lenses (Device)
Active Comparator: Single vision spectacle lenses
Active Comparator: Single vision spectacle lenses
干预措施: Single vision spectacle lenses (Device)
结局指标
主要结局
Axial length
时间窗: 24 months
Change in axial length relative to baseline
Cycloplegic SER
时间窗: 24 months
Change in spherical equivalent cycloplegic autorefraction relative to baseline
次要结局
未报告次要终点