Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.
研究概览
简要总结
The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.
详细描述
A prospective, randomized, controlled clinical trial was designed for assessing the effect of single-vision spectacles on myopic progression. 30 myopic subjects, aged 6-16 years old, with a spherical equivalent refraction between -0.50D and -6.00D, were recruited. A random number table was used to allocate participants into either a) part-time use of single-vision spectacles, or b) full-time use of single-vision spectacles. Part-time use was for 4-6 hours a day, 7 days a week for a year. Clinical assessment included follow-up at 6 months and at 12 months upon allocation. The primary outcomes were a) change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction, and b) change in axial eye length (AL). The secondary outcomes were a) change in choroidal thickness (ChT), and b) assessment of the subjective tolerance.
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
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 16 years old at the time of enrollment.
- •Best-corrected visual acuity (BCVA) LogMAR 0.1 or better, in each eye.
- •Cycloplegic Autorefraction: Myopia, SER between -0.50D and -6.00D, in each eye. Astigmatism less than or equal to 1.50D, in each eye. Anisometropia less than or equal to 1.50D between the two eyes.
- •Absence of any ocular or systemic condition that could influence refractive development, other than myopia.
- •Eagerness to participate in this study and receive myopia treatment in a randomized fashion. Availability for at least 1-year follow-up. Subject parent's or guardian's understanding of the protocol and acceptance to participate, providing a signed consent on behalf of the subject.
排除标准
- •Presence of strabismus.
- •Presence of amblyopia.
- •Prematurity (gestational age less than 37 weeks).
- •Presence of an ocular condition affecting refraction (ie. cataract, dislocated lens).
- •Presence of a systemic condition affecting refraction (ie. Down syndrome, Marfan syndrome).
- •Allergy to cyclopentolate. Severe ocular or systemic allergies.
结局指标
主要结局
Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.
时间窗: Baseline to 6-months, and baseline to 12-months.
Change in axial length (AL).
时间窗: Baseline to 6-months, and baseline to 12-months.
次要结局
- Change in choroidal thickness (ChT).(Baseline to 6-months, and baseline to 12-months.)
- Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study.(Baseline to 12-months.)
研究者
Asimina Mataftsi
Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus
Aristotle University Of Thessaloniki