Low strength atropine (0.01%) eyedrops for preventing progression of Compound Myopic Astigmatism in children and young adults-A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome will be progression of the myopic component of Compound Myopic astigmatism estimated as the change in spherical equivalent refractive error relative to the baseline
研究概览
简要总结
STUDY OBJECTIVE : To evaluate the efficacy and safety of low strength atropine eyedrops 0.01% in preventing progression of compound myopic astigmatism in children and young adults
CLINICAL HYPOTHESIS : Low dose atropine (0.01%) eyedrops is effective in preventing or slowing down the progression of myopic component of Compound myopic astigmatism in children as well as young adults, with minimal or insignificant side effects.
Single centre, Randomised Controlled Trial; Parallel group, Intervetional study design
The primary outcome will be progression of the myopic component of Compound Myopic astigmatism estimated as the change in spherical equivalent refractive error relative to the baseline. The secondary outcome will be the change in axial length with respect to the baseline measurement.
The ATOM studies established the effect of Atropine in preventing the progression of low to moderate myopia and it was concluded that at low strength of 0.01% the drug showed optimum efficacy with minimal side effects and minimal rebound.
However the study failed to study high myopes (>6 D) and children above 12 years while myopic progression can continue in young adults. Also the study duration was limited which fails to bring out the persistence of the long term results.
The study also excluded eyes with coexisting astigmatism > 1.5D
In our experience it is seen that Compound Myopic astigmatism is the most common refractive error in children in our population, rather than Simple Myopia and the myopic component of Compound Myopic astigmatism has been shown to progress as in simple myopia.
So we designed this study to study the efficacy of low strength Atropine (0.01%) in the Indian population, to assess its efficacy in Compound myopic astigmatism and to assess the persistence of the efficacy as well as the safety profile for a longer period. Also we intended to include a higher age group ie upto 15 years (Inclusion age: 5-15 years) which was not included in the ATOM studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children or Young adults in the age group 5-15 years.
- •2.Myopic refractive error of spherical equivalent > 1.00D as measured by cycloplegic refraction 3.Astigmatism of > 1.50D as measured by cycloplegic refraction 4.Documented progression of myopic component of Compound Myopic astigmatism 5.Ability to understand and follow the study instructions you receive and likely to be amenable for 1 year followup.
- •6.Normal ocular health other than refractive error 7.Normal Intraocular pressure (<21 mm Hg).
排除标准
- •1.Known Allergy or hypersensitivity to Atropine, Cyclopentolate, Phenyl ephrine or Proparacaine 2.Amblyopia in atleast one eye 3.History of significant cardiac or respiratory illness 4.Current enrolment in another investigational study or participation in such a study within 30 days of entry into this study 5.No previous or current use of contact lenses or bifocals or progressive lenses or other forms of treatment (including Atropine in any strength) for myopia 6.Patient has a condition or situation which in the investigators opinion, may put the patient at a significant risk, may confound the study results, or interfere with the participation in the study.
结局指标
主要结局
The primary outcome will be progression of the myopic component of Compound Myopic astigmatism estimated as the change in spherical equivalent refractive error relative to the baseline
时间窗: 1 year
次要结局
- The secondary outcome will be the change in axial length with respect to the baseline measurement.(1 year)