A Study on Efficacy and Visual outcome of Posterior chamber Phakic Intra-ocular lens in High Myopia
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Improvement in Best corrected visual acuity
研究概览
简要总结
Phakic IOL means that natural crystalline lens is retained and an intraocular lens (IOL) is placed into the eye. The phakic IOL implant functions as an internal contact lens and the view through the phakic IOL is natural and of a good quality. Phakic IOLs are used to treat high myopia or hyperopia with or without astigmatism who are not fit for LASIK or mild keratoconus
Primary Objective of this study is Evaluate the Visual Outcome and Ensure the Safety of Posterior Chamber Refractive Implantable Lens (RIL) in High Myopic Patients
In this Study all Patients will be Thoroughly Evaluated Pre-Operatively and Follow Up done at 1st week, 2nd Week, 4th Week , 3rd Month and 6th Month.The following Parameters will be assessed Visual Acuity, Anterior Chamber Depth, CCT, Endothelial Cell Count, IOP and Iridocorneal angle.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •Age >21 years
- •Stable refraction
- •Patients with myopia >-6.00D
- •Iridocorneal angle > 30 degree
- •Anterior chamber depth >2.7mm
- •Endothelial cell count > 2500 cells/sq.mm
- •Central corneal thickness >0.400 mm.
排除标准
- •Age <18 years
- •Unstable refraction
- •Hyperopia
- •AC depth <2.7mm.
- •Iridocorneal angle <30 degrees
- •Endothelial cell count <2500 cells /sq mm
- •Central corneal thickness <0.400 mm.
- •Any Lens Changes 9.Any Retinal degeneration which cause Impaired vision 10.Any Inflammatory Pathologies of Eye 11.Any Previous Ocular Surgeries.
结局指标
主要结局
1. Improvement in Best corrected visual acuity
时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month
2.Anterior chamber depth
时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month
3.Iridocorneal angle
时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month
4.Endothelial count
时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month
6.Central corneal thickness
时间窗: Post Op 1st Week 2nd Week 4th week 3rd Month and 6th Month
次要结局
- 1.Intra Ocular Pressure(2.RIL Vaulting between Natural Lens and Phakic IOL)
