Clinical outcomes following capsulotomy versus capsular bag fixated presbyopia correcting toric intraocular lenses - A prospective comparative study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To analyze and compare prospectively the post-operative visual and refractive outcomes, contrast sensitivity and patient satisfaction following implantation of 2 types of presbyopia correcting toric intra ocular lenses.
研究概览
简要总结
Title: Clinical outcomes following capsulotomy versus capsular bag fixated presbyopia correcting toric intraocular lenses - A prospective comparative study
Aim: To study the visual and refractive outcomes of two different trifocal toric lenses along with the analysis of axial and rotational stability.
M**ethodology:**A total of 120 eyes from 60 patients were included in the study. All patients underwent bilateral Femtosecond laser assisted cataract surgery (FLACS) using LENSAR machine. Group A included 30 patients with PanOptix toric IOL type of lens implanted in the capsular bag. Group B included 30 patients with Femtis M plus toric IOL clipped to the anterior capsulotomy. Post-operative visual and refractive outcomes, contrast sensitivity and patient satisfaction were evaluated. Axial as well as rotational stability of the IOLs at day 1, day 7, 1 month, 6 months and 12 months post-operative was analysed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 21.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Bilateral Implantation (Second eye surgery within 10 +/- 4 days).
- •Cataractous eyes with no comorbidity.
- •Regular corneal topography and corneal astigmatism.
- •Regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D.
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures.
排除标准
- •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.
- •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.
- •Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia.
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under Mesopic/scotopic conditions).
结局指标
主要结局
To analyze and compare prospectively the post-operative visual and refractive outcomes, contrast sensitivity and patient satisfaction following implantation of 2 types of presbyopia correcting toric intra ocular lenses.
时间窗: post op day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up
次要结局
- To compare the axial as well as rotational stability of the study IOLs at day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up.(post op day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up)
研究者
Dr Sri Ganesh
Nethradhama Super-speciality Eye hospital