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

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.

Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system.

PURPOSE: To compare corneal incision size and intraocular lens (IOL) performance/behavior following implantation with the following delivery systems: system U (UltraSert®), system S (Hoya iSert® 250/251), system T (Tecnis® iTec), and a manual system (Monarch® III Delivery System). SETTING: Six study sites (four in Spain and two in France). DESIGN: Prospective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study. MATERIALS AND METHODS: Subjects were enrolled based on predetermined inclusion/exclusion criteria. The effectiveness end points compared corneal incision size and enlargement after IOL implantation (day of surgery) among all delivery systems. Exploratory end points included mean enlargement of corneal incision size, rates of trapped trailing haptic, IOL adherence to the plunger tip, nozzle tip splitting, and mean surgically induced astigmatism (SIA) at postoperative visit. RESULTS: One hundred and nine subjects participated in the study. The mean corneal incision size following IOL implantation was 2.35±0.019 mm for system U, 2.47±0.016 mm for system T, 2.54±0.019 mm for system S, and 2.49±0.011 mm for the manual system. There were five instances of trapped trailing haptic (all system T group, N=26), one instance of IOL adherence to the plunger tip (system S group, N=26), and six instances of nozzle tip splitting (all system S group, N=26). System U had the least SIA (postoperative Day 1) (SIA Centroid = 0.10 diopters [axis: 83.06°]). CONCLUSION: Preloaded delivery system U supported the completion of surgery with the smallest incision size, the least SIA (postoperative Day 1), and no trapped trailing haptics or nozzle tip splitting compared to two other preloaded systems and one manual system.

Monochromatic aberrations in hyperopic and emmetropic children.

We investigated differences in higher order monochromatic aberrations between hyperopic and emmetropic eyes from two large cohorts (mostly 6 and 12 year old) of Caucasian children. Additionally, we investigated the differences of higher order monochromatic aberrations between age groups. In both cohorts, hyperopic eyes had significantly higher levels of positive spherical aberration (SA) and higher orders (HO) RMS than emmetropic eyes. Higher levels of positive SA were also found in the older cohort (irrespectively of the refractive error) although this difference was statistically significant only for emmetropic, low hyperopic and moderate hyperopic eyes. The observed higher levels of positive SA found in hyperopic eyes could explain for the previously reported differences in accommodative responses between hyperopic and non-hyperopic eyes. Our results provide some evidence of a relationship between ocular changes that typically occur during eye growth and the observed levels of higher order aberrations in children eyes.

Comparison of aberrometer and autorefractor measures of refractive error in children.

PURPOSE: The purpose of this study was to evaluate and compare the Complete Ophthalmic Analysis System (COAS) G200 Aberrometer (Wavefront Sciences Inc., Albuquerque, NM) and Canon RK-F1 Autorefractor (Canon Inc., Tokyo, Japan) for measuring refractive errors in young children. METHODS: The Sydney Myopia Study is a population-based study of refractive error and eye health in young Australian children. Cycloplegic refractions were performed on 1504 school year 1 students (mostly 6 years old) and 890 school year 7 (mostly 12 years old) students using both the COAS G200 Aberrometer and Canon RK-F1 autorefractor. Refractive data were analyzed using power vectors. Mean differences and 95% limits of agreement were determined for refractive components between the two instruments. RESULTS: The mean age +/- standard deviation was 6.7 +/- 0.4 years (range, 5.5-9.1 years) and 12.6 +/- 0.5 years (range, 11.1-14.4 years) for the year 1 and year 7 students, respectively. Mean paired differences for the M component (spherical equivalent) between the COAS G200 and Canon RK-F1 were <0.25 D in both age groups and were statistically significant in the year 1 group only (p < 0.001). Small significant differences were found in the astigmatic components (J0 and J45) in both groups. A smaller coefficient of agreement for the M component was found in the older group (0.54 D), whereas the coefficients of agreement of the astigmatic components (J0 and J45) were similar for both groups. CONCLUSIONS: The COAS G200 aberrometer was an easy-to-use instrument for the measurement of refractive error in children. In addition to being able to measure higher and lower order aberrations, the COAS G200 provides refractive error measurements comparable to those of an autorefractor.