Comparison of pupillary miosis induced by photodisruption following femtosecond laser cataract surgery on two different operating systems
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- LENSAR
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess and compare the pupillary miosis induced by photodisruption following femtosecond laser cataract surgery on two different operating system namely LENSAR and CATALYS.
研究概览
简要总结
Femtosecond laser assisted cataract surgery was introduced to achieve high level of precision, accuracy and customization. In order to achieve good surgical outcome, intraoperative mydriasis is of paramount importance but the major drawback of FLACS is pupillary miosis leading to complications like posterior capsule rupture, vitreous loss, corneal edema and cystoid macular edema which in turn affects the final outcome of surgery and recovery. The main factor being significant increase of prostaglandins concentrations (PGE2) which induced the miosis. Other Inflammatory cytokines like IL-1β, IL-6 along with PGE2 are also significantly increased which leads to intraoperative miosis. In order to assess whether photodisruption following femtolaser will induce any pupillary miosis or not and to compare the extent of the same, using LENSAR and CATALYS FS laser systems, the present study will be conducted. To measure the pupillary size, colvard pupillometer will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 40-80 years Patients having adequate pupil dilation (more than 7mm) Patients with clear ocular media other than cataract in each eye.
排除标准
- •Patients having non dilating pupil or dilation less than 6mm Patients with pupillary , capsular or zonular adnormalities Patients with cornea guttata, corneal scarring, keratoplasty, irregular astigmatism Patients with history of significant ocular trauma or prior ocular surgery Patients with history of current inflammatory eye disease or other ocular diseases Patients with history of rheumatic diseases or other immune diseases Patients on systemic medications like NSAIDS or Steroids Patients currently on glaucoma medications or any other topical medications.
结局指标
主要结局
To assess and compare the pupillary miosis induced by photodisruption following femtosecond laser cataract surgery on two different operating system namely LENSAR and CATALYS.
时间窗: Study involves measuring pupillary miosis on the day of surgery, it does not involve any post operative evaluation.
次要结局
- •To evaluate consequences of decrease in pupil size and additional tools required for the management of the same(•Study involves measuring pupillary miosis and consequences of decrease in pupil size and additional tools required for the managment on the day of surgery, it does not involve any post operative evaluation.)