Comparison of postoperative outcomes following Toric IOL implantation using an image guided versus a femto laser enabled capsular marking system for intraoperative IOL positioning.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- LENSAR
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- − Post-op residual cylinder (D)
研究概览
简要总结
It would be a matter of great interest to study and compare two different types of registration systems, i.e., limbal (IOL Master 700 and Callisto eye) and iris registration (LENSAR laser system and Intelliaxis) for precision of image capturing, and accuracy of cylinder correction following toric IOL implantation. The present study would thus be conducted to compare both the systems in terms of success and precision of intra-operative image capture as well as outcomes of astigmatism correction following implantation of a toric IOL implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •âˆ’ Healthy eyes besides age related cataract, aged between 40-80 years − Eyes undergoing femtolaser assisted surgery with implantation of a hydrophobic monofocal toric IOL − Regular corneal topography and corneal astigmatism within the range of 0.75D to 4.00D − Availability, willingness, and sufficient cognitive awareness to comply with examination procedures − Signed informed consent.
排除标准
- •âˆ’ Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation, and corneal endothelial cell insufficiency.
- •âˆ’ Subjects with any systemic disease that could increase operative risk or confound the outcome − Pregnant or lactating or planning a pregnancy at the time of enrolment − Any patient who is taking part in another study involving ocular surgery − Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under Mesopic/scotopic conditions) − Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia.
结局指标
主要结局
− Post-op residual cylinder (D)
时间窗: 1 WEEK, 1 MONTH, 3 MONTHS
− Uncorrected Distance Visual Acuity (UDVA) and Corrected Distance
时间窗: 1 WEEK, 1 MONTH, 3 MONTHS
Visual Acuity (CDVA) using ETDRS charts at 4m
时间窗: 1 WEEK, 1 MONTH, 3 MONTHS
− Manifest refraction (Sphere, Cylinder, Spherical Equivalent)
时间窗: 1 WEEK, 1 MONTH, 3 MONTHS
− Rotational stability using dilated clinical examination and I-trace
时间窗: 1 WEEK, 1 MONTH, 3 MONTHS
(Tracey technologies, Hoya, Japan).
时间窗: 1 WEEK, 1 MONTH, 3 MONTHS
次要结局
- 1.Precision (Success/ Failure) of intra-operative image capture(2.Intra-operative adverse events /post-op rotation/ re-surgery rate)