跳至主要内容
临床试验/NCT03375996
NCT03375996已完成不适用

Evaluation of a Preoperative Pharmacological Protocol for Mydriasis in Femtosecond Laser-assisted Cataract Surgery

CHU de Reims1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
60
试验地点
1
主要终点
Pupil diameter > 6 mm all along the surgical procedure

研究概览

简要总结

Laser-assisted cataract surgery is an innovative and growing procedure to improve the safety and results of modern cataract surgery. However, this technique faces to some obstacles: economics in the one hand due to the cost and time spent for the laser procedure before the conventional surgery, and technical in the other hand, especially due to some loss of pupil dilation during the surgery, which is highly important to ensure a perfect procedure. The present study aims at assessing a pharmacological protocol to maintain an accurate pupil dilation all along the surgery in order to improve the whole procedure.

详细描述

Femtosecond laser-assisted cataract surgery (FLACS) is a major surgical development that would allow systematization of surgery and even improved safety of the procedure. The development of this new surgical technique must now face certain obstacles, in particular (i) financial considering the extra cost generated by the use of the laser and (ii) technique due to the need to re-learn certain gestures and certain variations related to the laser procedure and more specifically the instability of the pupillary mydriasis (dilatation) during the actual surgery. The use of a systematic preoperative pharmacological mydriasis protocol should allow maximum intraoperative mydriasis to be maintained, allowing satisfactory surgery throughout the procedure. Several drugs or medical devices are now indicated in cataract surgery, but their effectiveness has not been specifically evaluated for the laser technique. This study could thus make it possible to validate or not a protocol of mydriasis that could make consensus in the future for the practice of FLACS.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

FLACS group

Patient presenting cataract and scheduled for laser-assisted cataract surgery

干预措施: cyclopentolate 0.5% eye drops (Drug)

结局指标

主要结局

Pupil diameter > 6 mm all along the surgical procedure

时间窗: Day 0

a posteriori pupil measurement using the peroperative movie recorded via the operative microscope during each surgery.

次要结局

  • Pupil diameter variation at each time of the surgery(Day 0)
  • Surgeon satisfaction(Day 0)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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