INTRODUCTION: Improvements in cataract surgery led to the availability of preloaded IOL delivery systems. These are expected to reduce overall surgery time while being safe and effective. This study evaluates the safety and manageability of the 2-component autoloading system SAFELOADER® (HumanOptics AG, Erlangen, Germany) and compares these results to two other systems. MATERIAL AND METHODS: A total of 167 eyes were enrolled to this single centre prospective study. In 67 eyes, the IOLs were implanted via the SAFELOADER system, in 50 eyes via another preloaded system (TECNIS iTec® Preloaded Delivery System, Johnson & Johnson Vision, Santa Ana, CA, USA) and in 50 eyes via a manual implantation system (UNFOLDER® Platinum 1 Series Delivery System, Johnson & Johnson Vision, Santa Ana, CA, USA). IOL preparation time and implantation time were measured in seconds for each device. The OR workflow and handling of the device by the surgeon and the scrub nurse were rated by a grading system from 1 (very good) to 5 (very poorly). RESULTS: The SAFELOADER and iTec were faster and handier than the manually loaded system. Regarding preparation time, the SAFELOADER with a median of 6.5 (5.3 - 6.9) seconds (s) was about one second slower (p < 0.0001) than iTec with 5.2 s (4.5 - 6.5). Both were significantly faster (p < 0.0001) than the UNFOLDER with 26.9 s (20.6 - 30.1). Implantation time was similar between SAFELOADER with 7.2 s (5.3 - 8.6), iTec with 7.3 s (5.9 - 8.3) and UNFOLDER with 7.2 s (5.9 - 7.6). When graded, SAFELOADER 2.0 (1.0 - 3.0) and iTec 1.0 (1.0 - 3.0) were significantly (p < 0.0001) better than the manual system 5.0 (3.0 - 5.0) with respect to overall OR workflow. The surgeon rated the handling of SAFELOADER and iTec (both median 1.0; 1.0 - 2.0) similarly and significantly better (p < 0.001) than that of the UNFOLDER 2.5 (1.0 - 4.0). For the scrub nurse, SAFELOADER 1.0 (1.0 - 2.0) was significantly better (p < 0.0001) in handling than iTec 2.0 (1.0 - 3.0) and UNFOLDER 4.0 (2.0 - 5.0). CONCLUSION: The 2-component autoloading system SAFELOADER® is intuitive in handling, fast and effective in implantation of the IOL and very safe. Georg Thieme Verlag KG Stuttgart · New York.
INTRODUCTION: Improvements in cataract surgery led to the availability of preloaded IOL delivery systems. These are expected to reduce overall surgery time while being safe and effective. This study evaluates the safety and manageability of the 2-component autoloading system SAFELOADER® (HumanOptics AG, Erlangen, Germany) and compares these results to two other systems. MATERIAL AND METHODS: A total of 167 eyes were enrolled to this single centre prospective study. In 67 eyes, the IOLs were implanted via the SAFELOADER system, in 50 eyes via another preloaded system (TECNIS iTec® Preloaded Delivery System, Johnson & Johnson Vision, Santa Ana, CA, USA) and in 50 eyes via a manual implantation system (UNFOLDER® Platinum 1 Series Delivery System, Johnson & Johnson Vision, Santa Ana, CA, USA). IOL preparation time and implantation time were measured in seconds for each device. The OR workflow and handling of the device by the surgeon and the scrub nurse were rated by a grading system from 1 (very good) to 5 (very poorly). RESULTS: The SAFELOADER and iTec were faster and handier than the manually loaded system. Regarding preparation time, the SAFELOADER with a median of 6.5 (5.3 - 6.9) seconds (s) was about one second slower (p < 0.0001) than iTec with 5.2 s (4.5 - 6.5). Both were significantly faster (p < 0.0001) than the UNFOLDER with 26.9 s (20.6 - 30.1). Implantation time was similar between SAFELOADER with 7.2 s (5.3 - 8.6), iTec with 7.3 s (5.9 - 8.3) and UNFOLDER with 7.2 s (5.9 - 7.6). When graded, SAFELOADER 2.0 (1.0 - 3.0) and iTec 1.0 (1.0 - 3.0) were significantly (p < 0.0001) better than the manual system 5.0 (3.0 - 5.0) with respect to overall OR workflow. The surgeon rated the handling of SAFELOADER and iTec (both median 1.0; 1.0 - 2.0) similarly and significantly better (p < 0.001) than that of the UNFOLDER 2.5 (1.0 - 4.0). For the scrub nurse, SAFELOADER 1.0 (1.0 - 2.0) was significantly better (p < 0.0001) in handling than iTec 2.0 (1.0 - 3.0) and UNFOLDER 4.0 (2.0 - 5.0). CONCLUSION: The 2-component autoloading system SAFELOADER® is intuitive in handling, fast and effective in implantation of the IOL and very safe. Georg Thieme Verlag KG Stuttgart · New York.
Authors: Daniel Black; Dean Corbett; Timothy V Roberts; Brendan Cronin; Pamela J Smith; D Priya Janakiraman; Beth E Jackson Journal: Clin Ophthalmol Date: 2020-08-12