[Safety First - Evaluation of IOL Injector Systems]

Area of Science:

• Ophthalmology
• Surgical Technology
• Medical Devices

Background:

• Advancements in cataract surgery have introduced preloaded intraocular lens (IOL) delivery systems to enhance efficiency and safety.
• This study assesses the safety and manageability of the SAFELOADER® 2-component autoloading system in comparison to other IOL delivery methods.

Purpose of the Study:

• To evaluate the safety and manageability of the SAFELOADER® system for IOL implantation.
• To compare the SAFELOADER® system's performance, including preparation and implantation times, and operating room workflow, against two other IOL delivery systems.

Main Methods:

• A prospective, single-center study involving 167 eyes.
• IOLs were implanted using the SAFELOADER® system (n=67), TECNIS iTec® (n=50), or UNFOLDER® Platinum 1 Series (n=50).
• Preparation and implantation times were measured; OR workflow and device handling were rated using a 1-5 grading scale.

Main Results:

• SAFELOADER® and iTec demonstrated significantly faster preparation times compared to the manual UNFOLDER® system (p<0.0001).
• Implantation times were comparable across all three systems (SAFELOADER®: 7.2s, iTec: 7.3s, UNFOLDER®: 7.2s).
• SAFELOADER® and iTec received significantly better ratings for overall OR workflow and surgeon handling compared to UNFOLDER® (p<0.0001 and p<0.001, respectively). Scrub nurse handling was rated significantly better for SAFELOADER® than for iTec and UNFOLDER® (p<0.0001).

Conclusions:

• The 2-component autoloading SAFELOADER® system is intuitive, fast, and effective for intraocular lens implantation.
• The system offers significant advantages in terms of operating room workflow and ease of handling for both surgeons and scrub nurses, contributing to overall surgical safety.