Clinical study using a new phacoemulsification system with surgical intraocular pressure control

Area of Science:

• Ophthalmology
• Surgical Technology
• Medical Devices

Background:

• Cataract extraction is a common surgical procedure.
• Optimizing surgical parameters is crucial for patient outcomes and efficiency.
• Phacoemulsification techniques continue to evolve with technological advancements.

Purpose of the Study:

• To compare cumulative dissipated energy (CDE), aspiration fluid volume, and aspiration time during phacoemulsification cataract extraction.
• To evaluate two distinct surgical fluidic configurations: active-fluidics and gravity-fluidics.

Main Methods:

• A prospective randomized clinical case series was conducted across three international sites.
• Each patient underwent sequential bilateral cataract surgery, with one eye randomized to active-fluidics and the other to gravity-fluidics.
• Key metrics including CDE, aspiration fluid volume, and aspiration time were meticulously recorded and compared between the two configurations.

Main Results:

• The active-fluidics configuration demonstrated significantly lower CDE compared to gravity-fluidics (P < .001).
• Significantly reduced aspiration fluid volume (P < .001) and shorter aspiration times (P < .001) were observed with the active-fluidics system.
• No serious ocular adverse events related to the study devices were reported.

Conclusions:

• The active-fluidics configuration offers superior surgical efficiency in phacoemulsification cataract extraction.
• Reduced CDE, aspiration fluid, and aspiration time indicate potential benefits for both patient and surgeon.
• This study highlights the advantages of advanced fluidic systems in modern cataract surgery.