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临床试验/NCT05119270
NCT05119270撤回不适用

Comparison of Corneal Endothelial Cell Loss and Cumulative Dissipated Energy Between Femtosecond Laser Assisted Cataract Surgery and Standard Phacoemulsification With the Active Sentry or OZil Handpiece

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
90
试验地点
1
主要终点
Corneal endothelial cell loss (Specular microscopy)

研究概览

简要总结

The main goal of this study is to compare traditional cataract surgery with two new technologies: the femtosecond laser and the new Active Sentry handpiece.

The femtosecond laser is used in several fields of ophthalmology and allows to automate multiple key steps of cataract surgery.

The new generation of handpiece called Active Sentry has the particularity to detect the pressure inside the eye in real time and to adjust it to avoid large variations.

Theses technologies would potentially increase the efficacy and safety of standard cataract surgery. This study therefore aims at evaluating the differences in cumulative dissipated energy and endothelial cell loss between femtosecond laser assisted cataract surgery with the new Active Sentry handpiece compared to standard phaco with new (Active Sentry) or older handpieces (OZil).

详细描述

Phacoemulsification (phaco) has been the standard technique for cataract surgery for several decades. It involves the removal of the lens nucleus after ultrasound fragmentation. Recently, Femtosecond Laser Assisted Cataract Surgery (FLACS) has become a new popular method amongst ophthalmologists.

The femtosecond laser (LFS) is a new technology that is being used for cataract surgery. The LFS has a femtosecond pulse duration, which reduces damage to collateral tissue and increases the efficacy and safety of the procedure. The LenSx laser (Alcon Laboratories Inc., USA) is one of the most widely used LFS for cataract surgery and is part of the CENTURION Vision system. The LFS automates key steps in the procedure including capsulorhexis, incision making and phaco, limiting human variability and potentially improving the efficiency and safety of the surgery. The Frequency Domain - Optical Coherence Tomography (FD-OCT) optical imaging system provides high-resolution, real-time visualization of ocular structures and their dimensions. The device sends the results to the interface which programs the laser and indicates the exact location, size and depth of the desired incisions.

Several handpieces are used to perform phacoemulsification. The traditional handpiece is named OZil and is part of the Infiniti Vision System (Alcon Laboratories Inc.) which was introduced in 2006 and has since revolutionized the phaco technique with its new rotational technology. This handpiece increased phaco efficacy by reducing core fragment repulsion, collateral tissue damage, and the amount of energy required. However, a new generation of handpiece called Active Sentry (Alcon Inc.), which is part of the new Active Fluidics technology, has now the added feature of detecting the pressure inside the eye in real time and adjusting it to avoid significant variations. This handpiece can also decrease the amount of fluid and energy used during the procedure, increasing the efficacy and safety of phacoemulsification.

Different methods to quantify the collateral damage caused by cataract surgeries are the count of endothelial cell loss (ECL) as well as the amount of energy required to fragment the lens (CDE: cumulative dissipated energy). FLACS may reduce the CDE required during phaco, thereby reducing the damage to the cornea of the eye (including the loss of endothelial cells of the cornea).

Despite a large number of publications on this topic, recent meta-analyses on the effect of FLACS on ECL and CDE were found to be inconsistent. Few studies have demonstrated a decrease in ECL as well as CDE required in patients undergoing FLACS when compared to standard phaco, but long-term results were not conclusive.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

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

  • Adult patient (over 18 years of age)
  • Patients undergoing uncomplicated cataract surgery with intraocular lens implantation
  • Ability to provide informed consent;
  • Ability to be followed for the entire duration of the study.

排除标准

  • Minor patient (under 18 years of age)
  • Unable to give informed consent
  • Unable to be followed for the duration of the study
  • Another surgery combined with cataract extraction
  • History of ocular surgery
  • Patient with concomitant ocular diseases other than cataract (such as corneal, retinal, or glaucoma diseases)
  • Irregular corneal astigmatism or keratoconus

结局指标

主要结局

Corneal endothelial cell loss (Specular microscopy)

时间窗: Baseline, 1 month, 3 months

Change in corneal endothelial cells count after cataract surgery

Cumulative dissipated energy

时间窗: Peroperatively

Amount of energy used during phacoemulsification

次要结局

  • Binocular uncorrected visual acuities for distance (6 meters)(Baseline, 1 day, 2 weeks, 1 month, 3 months)
  • Postoperative residual astigmatism(Baseline, 3 months)
  • Patient reported visual disturbances(Baseline, 3 months)
  • Central corneal thickness(Baseline, 1 month, 3 months)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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