ABSTRACT
Purpose: To obtain consensus on the key areas of burden associated with existing devices and to understand the requirements for a comprehensive next-generation diagnostic device to be able to solve current challenges and provide more accurate prediction of intraocular lens (IOL) power and presbyopia correction IOL success. Patients and Methods: Thirteen expert refractive cataract surgeons including three steering committee (SC) members constituted the voting panel. Three rounds of voting included a Round 1 structured electronic questionnaire, Round 2 virtual face-to-face meeting, and Round 3 electronic questionnaire to obtain consensus on topics related to current limitations and future solutions for preoperative cataract-refractive diagnostic devices. Results: Forty statements reached consensus including current limitations (n = 17) and potential solutions (n = 23) associated with preoperative diagnostic devices. Consistent with existing evidence, the panel reported unmet needs in measurement accuracy and validation, IOL power prediction, workflow, training, and surgical planning. A device that facilitates more accurate corneal measurement, effective IOL power prediction formulas for atypical eyes, simplified staff training, and improved decision-making process for surgeons regarding IOL selection is expected to help alleviate current burdens. Conclusion: Using a modified Delphi process, consensus was achieved on key unmet needs of existing preoperative diagnostic devices and requirements for a comprehensive next-generation device to provide better objective and subjective outcomes for surgeons, technicians, and patients.
ABSTRACT
Purpose: This study aims to assess the time impact of ARGOS® (image-guided swept-source optical coherence tomography biometer integrated with operating room (OR) technologies (SS-OCT w/ORT)) compared to LENSTAR LS 900 (optical low-coherence reflectometry (OLCR)), IOLMaster 500 (partial coherence interferometry (PCI)), and IOLMaster 700 (SS-OCT) on efficiency in the cataract evaluation and surgery. Patients and Methods: Data from 212 patients (two study sites) who underwent evaluation and/or cataract surgery were collected. The primary objective was to compare the performance of four biometers; statistical analyses were conducted to compare 1) biometer measurement times for all patients (ANOVA w/post-hoc Dunnett's test) and stratified by cataract density (ANOVA) and 2) rate of biometer acquisition failure (Chi-square test w/post-hoc Bonferroni correction). Real-world observational data collected were then used to develop a practice-based time-efficiency model to demonstrate the combined effect that adopting an SS-OCT w/ORT has on a practice's cataract workflow. Real-world data inputs included assessment of patient's eyes' cataract grade density, time taken for optical biometry, Manual A-scan (ultrasound biometer) when acquisition failed, and measurement times associated with other devices used in cataract evaluation and surgery. Results: For 208 patients (56% non-dense, 44% dense), the SS-OCT w/ORT biometer had a 0% acquisition failure (SS-OCT: 3% (p = 0.05); OLCR: 5% (p = 0.004); PCI: 15% (p < 0.0001)) and an average time savings of 30 seconds/patient compared to the other biometers in this study (p < 0.05). When acquisition failed, ultrasound biometry resulted in an additional 2.5 minutes/patient. For a cohort of 1000 patients, an SS-OCT w/ORT and an image-guidance system adopted at a practice using an SS-OCT, femtosecond laser, and intraoperative aberrometer offer up to 58% efficiency gain across the cataract workflow. Conclusion: Results from this study demonstrate an SS-OCT w/ORT's efficiencies in cataract evaluation and surgery driven by faster measurement times, reducing the need for ultrasound biometry, and its integration benefits with other devices.
