Multicenter Evaluation of Time, Operational, and Economic Efficiencies of a New Preloaded Intraocular Lens Delivery System versus Manual Intraocular Lens Delivery

Abstract

Purpose

To evaluate intraoperative intraocular lens (IOL) delivery time and total surgical case time using the UltraSert preloaded delivery system (System U) during routine cataract surgeries and to compare with the manually loaded Monarch delivery system (System M). Physician satisfaction with System U was also assessed.

Patients and Methods

In this prospective observational study, subjects ≥18 years old underwent cataract surgery in 1 eye and received the AcrySof IQ IOL via the manually loaded System M (n=103) or the AcrySof IQ IOL model AU00T0 via the preloaded System U (n=93). Procedures were digitally recorded by an external camera or by a camera within the operating microscope. Device preparation, IOL delivery, and IOL positioning times were evaluated by 2 independent graders. Pearson χ² test or Fisher exact test was used for categorical variables and Student’s t-test or Wilcoxon rank-sum test for continuous variables (all tests were 2-sided and performed at a 5% α-level). Physician satisfaction levels were assessed using questionnaires.

Results

Lens delivery time was similar for System U and System M (12.9±5.1 and 12.2±6.3 s; P=0.412). Mean device preparation time for System U was significantly shorter compared with System M (30.3±6.6 versus 59.8±31.0 s; P<0.05). This resulted in a significantly shorter total intraoperative time (device preparation + lens delivery) with System U versus System M (43.0±8.6 versus 72.0±32.5 s; P<0.05). Total surgical case time (device preparation + lens delivery + lens positioning and unfolding) was shorter for System U versus System M (56.6±12.6 versus 89.6±34.6 s; P<0.05). Physicians reported greater satisfaction levels with System U compared with other devices.

Conclusion

Use of the preloaded delivery system (System U) resulted in faster device preparation and reduced total surgical time compared with the manually loaded system (System M). System U was intuitive to use, and physicians preferred it to other devices.

Keywords:

• cataract surgery
• intraocular lens delivery time
• Monarch
• UltraSert

Abbreviations

IOL, intraocular lens.

Data Sharing Statement

Study data not reported in this publication are confidential.

Acknowledgments

Medical writing assistance was provided by Natalia Zhukovskaya, PhD, and Catherine DeBrosse, PhD, of ICON (North Wales, PA), and was funded by Alcon.

Disclosure

Javier Mendicute, Luis Pablo, Cédric Schweitzer, and Laurent Velasque received honoraria for participating in the study; the study was funded by Alcon Research LLC as a clinical trial, and fees paid were credited to Biodonostia Health Research Institute, a nonprofit public research center. Aldo A Martinez is an employee of Alcon Research LLC. Christine Bouchet was an employee of Alcon Research LLC at the time of the research. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was sponsored by Alcon Research LLC (Fort Worth, TX). The sponsor participated in study design; data management, analysis, and interpretation; and manuscript preparation, review, and approval. IMS Health Solutions France contributed to the management and conduct of the study on behalf of Alcon.