CTRI/2025/09/094092尚未招募不适用
Comparison of visual and refractive outcomes of Small Incision Lenticule Extraction in mild – moderate vs high Myopia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Proportional change in uncorrected visual acuity(UCVA)
研究概览
简要总结
This is a Quasi Experimental study , comparing visual and refractive outcome of small incision lenticule extraction in mild- moderate vs high myopia , will be conducted in Guru nanak eye centre taking two groups
less than 6 dioptre myopic patients
greater than equal to 6 dioptre myopia patients.
Primary objective- To evaluate of efficacy of SMILE procedure across different grades of myopia
Secondary objective- To assess the safety of SMILE procedure across different grades of myopia we
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years Stable refraction for 1 year prior to surgery Minimum preoperative corneal thickness of 480 microns Predicted residual stromal bed thickness morethan 280 microns Patients wearing soft contact lenses will be instructed to stop wearing them for at least 1 week.
排除标准
- •Patients with history of trauma , prior ocular surgery or corneal scars Keratoconus/ectatic corneal disorders Pregnancy or Lactation History of herpes keratitis Uncontrolled Glaucoma.
结局指标
主要结局
Proportional change in uncorrected visual acuity(UCVA)
时间窗: 3 months
次要结局
- 1) Proportional change in best corrected visual acuity(BCVA) at 3 months(2) Proportion of patients with Residual refractive error (spherical equivalent) at 3 months)
研究者
Dr Parul Jain
Guru Nanak Eye Centre
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluation Of Patient Satisfaction And Quality Of Vision After EDOF Or Trifocal IOL ImplantationCataractNCT07295119Azienda Ospedaliera Universitaria Integrata Verona36
已完成
不适用
Clinical Outcomes of Femtosecond Laser Presbyopia Treatment in Monofocal IOLsPresbyopiaNCT07384182Perfect Lens, LLC19
招募中
4 期
Odyssey Evaluation in Post LASIK PatientsCataractNCT07260695Center For Sight30
进行中（未招募）
不适用
Ocular Hypotony and Refractive Predictability in RRD SurgeryRhegmatogenous Retinal DetachmentNCT07283614Kazakh Eye Research Institute45
尚未招募
不适用
Clinical Outcomes of the Use of a Femtosecond Laser Treatment in a Patient With Implanted Monofocal IOLsNCT07447622Perfect Lens, LLC12