The Effectiveness and Acceptability of Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change in cycloplegic spherical equivalent after 2 years
研究概览
简要总结
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
详细描述
It has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. However, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. At present, there is insufficient evidence on whether these population needs myopia control intervention. Most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications.
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This study will utilize a Central Randomization System (CRS) for the random grouping and glasses allocation of study subjects during the clinical trial. Investigators and participants will be blinded to the intervention received until unblinding.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-25 years;
- •Myopia progression <= -0.50D in either eye in the past year (evaluated by -manifest refraction);
- •The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;
- •The subject eye's best corrected visual acuity <= logMAR 0.1;
- •Anisometropia does not exceed 1.50D.
排除标准
- •Current use of MC interventions or prior use of MC interventions within the past 6 months;
- •Disease or anatomical factors that affect the wearing of contact lenses;
- •History of myopia correction surgery;
- •Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;
- •pregnant female;
- •Other conditions deemed unsuitable by the investigators.
结局指标
主要结局
Change in cycloplegic spherical equivalent after 2 years
时间窗: 2 years after the baseline
The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.
次要结局
- Change in axial length after 2 years(2 years after the baseline)