A clinical study to correlate the pre and post operative intraocular pressure status in post FEMTOLASIK LASIK and Small Incision Lenticule Extraction in Indian myopic eyes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the pre & post intraocular pressure status following Small incision lenticule extraction FEMTOLASIK & LASIK in presence of altered corneal thickness and biomechanics in Indian myopic eye.
研究概览
简要总结
This is an observational study to assess the pre & post intraocular pressure(IOP) status following Small Inscision Lenticule Extraction Femtolasik & Lasik in the presence of altered corneal thickness & biomechanics in Indian myopic eyes and also to establish a nomogram to correlate between the apparent & real IOP using CORVIS ST NON CONTACT TONOMETER & APPLANATION TONOMETER & to to use the most suitable method to evaluate IOP in post refractive eyes . All myopic patients fulfilling the inclusion crietaria will be registered for the study & IOP will be measured before the surgery then after surgery at 1 weeks 4 weeks 8 weeks & 12 weeks.Statistical analysis will be performed by using descriptiveand inferential statistics using chi square test/fisher exact test forcategorical data. Independent sample t-test to comparemean values between the two groups and ANOVA followed by post-hoc test will beused to compare mean values between more than two groups.Paired t-test will be used to see therelative change with respect to time. Any other test if applicable at the time of analysis will be used. P-value less than 0.05 considered as significant at95% confidence level. The statistical software SPSS version24.0 or higher will be used in the analysis. Primary outcome can be seen at 3 months of each participant enrolled and nomogram will be prepared at one year of study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •age group between 20 to 30 years Both sex Clear cornea Astigmatism less than 1D Myopia of 2D to 5D Refraction stable for past 1 years(+/- 0.5Diopter) Indian ethnicity Central corneal thickness 520 to 550µm.
排除标准
- •Age less than 20 years or more than 30 years Any history of systemic illness like Diabetes, Hypertension, Asthma, collagen vascular disease, pregnancy ocular injuries.
- •Family history of glaucoma Hypermetropia Astigmatism more than 1D Myopic less than 2D or more than 5D Corneal pathology such as scarring & keratoconus Patients with history of any previous ocular surgery.
- •Ethnicity other than Indian.
- •Central corneal thickness less than 520 µm or more than 550µm Steroid responders.
结局指标
主要结局
To assess the pre & post intraocular pressure status following Small incision lenticule extraction FEMTOLASIK & LASIK in presence of altered corneal thickness and biomechanics in Indian myopic eye.
时间窗: 1 week 4 week 8 week 12 week
次要结局
- To establish a nomogram to correlate between apparent & real intraocular pressure using CORVIS ST NONCONTACT TONOMETER APPLANATION TONOMETER & to use most suitable method to evaluate intraocular pressure in post refractive eyes(1 year)