- Results of ReLEx SMILE for myopic astigmatism after cyclotorsion compensation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy of astigmatism correction and residual cylinder post operatively
研究概览
简要总结
The refractive outcome of astigmatism correction has been shown to depend on the accuracy of the axis treatment as any rotational movement of the eyes during treatment may cause shift in the treatment axis leading to undesirable results like undercorrection and induction of aberrations. Most of the currently available excimer laser platforms have the ability to detect and compensate for the static and dynamic cyclotorsion due to positional changes and treatment by advanced softwares and eye tracking. The Visumax femtolaser system at present does not have this feature , hence there is no method is described to compensate for rotational movement during the procedure. Through this study , we describe a method for the compensation of static cyclotorsional movements during ReLEx SMILE procdure in patients with myopic astigmatism (>0.75D), and study the reliability and efficacy of this technique in terms of cylindrical correction and post operative refractive outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Total number of eyes enrolled in the study will be 60 Patients of both sex, within the age group 21 – 40 years suitable for correction with ReLEx SMILE and who have healthy eyes besides- 1.myopic astigmatism of any degree with manifest cylinder > -0.75 D
- •Adequate Corneal pachymetry (> 480 D) 3.
排除标准
- •1.Myopic refractive error with manifest cylinder < -0.75 D or > -5 D 2.Hyperopic astigmatism 3.Irregular astigmatism 4.Inadequate Corneal pachymetry (<480 u)
- •K max >48 D 6.Evidence of keratoconus on corneal topography 7.External ocular disease- severe meibomian gland disease, severe contact lens induced allergy 8.Corneal scars or dystrophies 9.Socket / globe /lid anomalies – very deep set eyes, nanophthalmos 10.Severe meibomian gland disease, lid abnormalities 11.Severe atopy 12.Contact lens overuse 13.Pregnant and nursing mother 14.Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants.
结局指标
主要结局
Efficacy of astigmatism correction and residual cylinder post operatively
时间窗: post op day 1, day 15 and 3 month
次要结局
- change in topographic cylinder(post op day 1, day 15 and 3 month)