de Saint Jean Amélie, Dufournel Damien, Stodulka Pavel, Romano Fabrice, Bernard Aurélien
KERANOVA, Saint Etienne, France.
Gemini Eye Clinic, Zlín, Czechia.
Front Med (Lausanne). 2023 Apr 17;10:1157486. doi: 10.3389/fmed.2023.1157486. eCollection 2023.
To introduce a novel technology currently under final development before regulatory approvals for the furtherment of cataract surgery, using the FemtoMatrix laser system, and to demonstrate its safety and efficacy as compared to standard ultrasound phacoemulsification.
Thirty-three patients with bilateral cataracts were operated on with one eye undergoing PhotoEmulsification treatment on the FemtoMatrix device and the contralateral eye receiving the control procedure, i.e., standard ultrasound phacoemulsification treatment. The number of "zero-phaco" procedures (denoting that I/A alone was sufficient to aspirate the lens fragments and that no ultrasound energy was needed) was recorded and Effective Phaco Time (EPT) values were compared. The patient follow-up was 3 months.
Thirty-three eyes from a population with a mean cataract grade of 2.6 were treated on the FemtoMatrix, of which 29 were "zero-phaco" (88%). All patients were operated on by a single surgeon who was a relative novice to the technology (63 patients treated prior to this study). Conversely, of the 33 fellow eyes who underwent standard ultrasound phacoemulsification, none were zero-phaco (0%) - all required varying degrees of ultrasound energy to make lens aspiration possible. The mean EPT was significantly lower in the PhotoEmulsification laser group (0.2 ± 0.8 s) than in the phaco group (1.3 ± 1.2 s) ( < 0.0001). The safety profiles of the two procedures were comparable, with no device-related adverse events noted.
FemtoMatrix is a promising femtosecond laser platform that, when compared to phacoemulsification, significantly decreases or eliminates EPT altogether. The system is used to perform PhotoEmulsification, making zero-phaco cataract procedures feasible including in high-grade cataracts (>3). It enables personalized treatment by automatically measuring and adapting the laser energy required to obtain the most efficient cutting of the crystalline lens. This new technology appears to be safe and effective in cataract surgery.
在监管批准之前,介绍一种目前正在进行最终研发的新技术,用于推动白内障手术,该技术使用飞秒矩阵激光系统,并与标准超声乳化术相比,证明其安全性和有效性。
33例双侧白内障患者接受手术,一只眼睛在飞秒矩阵设备上进行光乳化治疗,对侧眼睛接受对照手术,即标准超声乳化治疗。记录“零超声乳化”手术的数量(表示仅通过水分离和抽吸就足以吸出晶状体碎片,无需超声能量),并比较有效超声乳化时间(EPT)值。患者随访3个月。
对平均白内障分级为2.6的人群中的33只眼睛进行了飞秒矩阵治疗,其中29只为“零超声乳化”(88%)。所有患者均由一位对该技术相对陌生的单一外科医生进行手术(在本研究之前治疗了63例患者)。相反,在接受标准超声乳化的33只对侧眼中,没有一只为零超声乳化(0%)——所有患者都需要不同程度的超声能量才能吸出晶状体。光乳化激光组的平均EPT(0.2±0.8秒)明显低于超声乳化组(1.3±1.2秒)(<0.0001)。两种手术的安全性相当,未发现与设备相关的不良事件。
飞秒矩阵是一个有前景的飞秒激光平台,与超声乳化术相比,可显著减少或完全消除EPT。该系统用于进行光乳化,使零超声乳化白内障手术可行,包括在高级别白内障(>3级)中。它通过自动测量和调整获得最有效切割晶状体所需的激光能量,实现个性化治疗。这项新技术在白内障手术中似乎是安全有效的。