The impact of preloaded intraocular lens implantation system (TECNIS iTec®) in routine cataract surgery in China: a time-motion analysis

Cataract is one of the major causes of blindness. With increasing age of global population, the number of patients with visual impairment caused by cataract may have reached 50 million by 2020 [15, 16]. Surgery remains the effective intervention to restore vision. In recent years, the improved materials, design and function of IOLs further drive the demand of cataract replacing surgeries [17,18,19].

The preloaded IOL has been demonstrated for its safety and effectiveness, long-term stability and excellent visual quality [6, 11, 20]. Surgeons and surgical technicians are more satisfied with the use of preloaded IOL, especially for the ease of lens preparation, the number of steps required and the total implantation time [20,21,22,23]. Additionally, the preloaded IOL offers several benefits over reusable, manual IOL, including a reduced chance of IOL damage during loading, shortened surgery time, the need for fewer surgical instruments, lower risk for contamination, and elimination of other manual setting errors, reduced incision size and quicker recovery [11, 20, 24]. At the same time, the particularities of preloaded IOL reflected in two aspects. On the one hand, it takes time for surgeons to learn and master how to use this preloaded IOL. On the other hand, the pushers of preloaded IOL are disposable and non-sterilizable, which is not in line with the sustainability concept.

As the population ages at an accelerated rate in China and worldwide, the number of cataract patients is projected to double within the next 30 years, presenting significant challenges for healthcare systems and limited resources. For a typical cataract surgery, the typical operation duration is as brief as 10–20 min. As a result, even minor improvements in surgical procedures and operating methods can quickly lead to substantial improvements in the number of cataract surgeries performed and the overall efficiency of the healthcare system. The personnel and operating room are both valuable and costly. Maximizing the efficiency of staff and operating rooms could allow for more patients to receive medical care. In this research, the effects on efficiency and revenue of adopting a preloaded IOL (TECNIS iTec® Preloaded Delivery System) were analyzed to determine the impact on the number of cataract surgeries performed and hospital revenue of transitioning from manual IOL to preloaded IOL. This study showed that application of the preloaded IOL significantly reduced the preparation time and operation time. The linear mixed model analysis indicated that the key factor affecting preparation time and operation time was the type of IOL. And it was estimated that switching from manual IOL to preloaded IOL could increase the surgery volume and revenue without additional staffs.

To our knowledge, this is the first study to evaluate the time savings and economic benefits from a hospital revenue perspective and a social productivity perspective of preloaded IOL in China with a large sample size. Our results were consistent with previous findings. A single-center, prospective and observational study in northwest China showed that the surgeon lens time was 0.7 min using preloaded IOL, which was a 46.2% reduction compared with manual IOL (1.3 min) [25]. By switching from manual IOL to preloaded IOL, annual cataract surgery volume would increase by 5.2%, accompanied by an increase in revenue by $284,352 [25]. A study conducted in the United States, France and Canada found that the use of preloaded IOL can reduce mean total procedure time by 6.2-12% [6]. The annual surgical volume would increase by 9.9% when switching from manual IOL to preloaded IOL [6]. Another study conducted in France and Spain showed that the implantation time of preloaded IOL was similar to that of manual IOL (12.9s vs. 12.2s), but the preparation time of preloaded IOL was shorter than that of manual IOL with a 49.3% reduction (30.3s vs. 59.8s) [21]. A study conducting in New Zealand and Australia found that the mean estimated time-savings per procedure was 54.9s compared with non-preloaded delivery systems [20]. The preloaded IOL has the design advantages for elimination of the need for loading IOL into the introducer and combining the introducer with the pusher, which reduced number of preparation steps and improves intraoperative efficiency. In contrast to previous studies, our study also showed that the preloaded IOL significantly saved more preparation time and operation time compared to manual IOL upon controlling for effects of preparer type, surgery staff type, and patient nuclear hardness grade on time. Other potential influential factors, such as surgeons with varying levels of ophthalmic surgical experience, adhesion between haptics and optics will be collected in the future study. In addition, our study also measured the labor loss of surgeons and surgical technicians from the perspective of society.

In the current study, the calculated potential increase in revenue was derived by three factors: the time saved by preloaded IOL system, the cost per age-related cataract surgery, and volume of age-related cataract surgery. As the preparation process and surgical procedure may vary by sites, we used average time saved in eight participating study sites to estimate the potential increased revenue, which likely is more representative of typical clinical settings in China. Clinical experts survey indicated that there was no difference in surgical costs between preloaded IOL and manual IOL, with no additional instrumentation costs and less pushers used for preloaded IOL surgery. The surgical volume from participating hospitals was also obtained from the clinical experts’ survey, which was based on the real-world data from their respective hospital electronic information system. Taken together, the results of our study appeared to be robust.

Potential limitations should be taken into consideration when interpreting the findings of this study. This study was an observational, non-interventional study, which was not possible to control for unobserved external factors in participating hospitals (e.g., surgical procedure flow, cataract case mix, patient characteristics, etc.). The implication on surgical volume and hospital revenue was projected based on historical record not a direct observation. In fact, the annual surgical volume of 8 hospitals from July 2020 to July 2021 was significantly lower compared to the years prior due to the impact of the COVID epidemic. As a result, the potential increase in revenue and loss of labor costs may have been underestimated. Finally, this study only focused on the economic impact of the application of preloaded IOL system without follow-up on clinical and patient-centered outcomes, such as patient quality of life and satisfaction with preloaded or manual IOL before and after the implementation of cataract patients. However, these limitations did not affect the conclusions of this study which focused on the surgical efficiency comparing the preloaded IOL system with manual IOL system.

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