Defocus Spectacles with 0.01 percent atropine eye drops for slowing myopia, a randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Spherical Equivalent Refraction
研究概览
简要总结
This is a prospective, randomized controlled cross-over trial evaluating the efficacy of Highly Aspherical Lenslet Target (HALT) defocus spectacles, both as monotherapy and in combination with low-dose atropine (0.01 percentage) eye drops, in controlling childhood progressive myopia in Indian children aged 6–14 years. The study follows a four-phase sequential design over 24 months:
Phase 1: One eye receives combination therapy (HALT + atropine), the other receives monotherapy (HALT).
Phase 2: Cross-over; monotherapy eye starts atropine, combination eye undergoes tapering.
Phase 3: Both eyes continue with HALT spectacles only.
Phase 4: Complete cessation of treatment in both eyes to assess for rebound myopia.
The primary outcome measures include change in axial length and cycloplegic spherical equivalent refraction. This study will help determine the relative effectiveness and sustainability of combination versus monotherapy in myopia control.
Primary Purpose of the Study:
To compare the effectiveness of HALT defocus spectacles alone versus in combination with low-dose atropine eye drops (0.01 percentage) in slowing childhood myopia progression, and to assess the short-term rebound effects after treatment cessation.
Study Hypothesis:
Combination therapy using HALT spectacles and low-dose atropine is more effective than HALT monotherapy in reducing myopia progression. Additionally, rebound myopia following withdrawal is expected to be less significant in eyes previously treated with combination therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Magnitude of myopia ranging from -1d to -8d ser in each eye.
- •Astigmatism less than -4d in each eye.
- •Documented progressive myopia with an increase of more than or equal to 0.5d ser in each eye in the previous year.
- •Children whose parents or guardian are willing to give a written informed consent.
排除标准
- •Children with any ocular or systemic co-morbidities.
- •Children with history of frequent eye rubbing.
- •Children who have best corrected visual acuity of less than or equal to 6 by 12 on Snellens chart.
- •Children having an inter-acuity difference of more than or equal to 2 lines on Snellens chart.
- •Myopia progression in the last year of less than -0.5d ser in either eye.
结局指标
主要结局
Spherical Equivalent Refraction
时间窗: 4 months
次要结局
- Axial length(4 months)
研究者
Dr Rimsha Parvez
Jupiter Hospital