In this retrospective study, performed at the Salerno University Hospital, the data of 295 eyes of 295 patients that underwent cataract extraction and IOL implantation, following refractive surgery, were examined.
The study was performed according to the Declaration of Helsinki guidelines. A written informed consent was acquired from all the participants. This study was approved by the local Institutional Review Board, Cometico Campania Sud, Italy, (protocol. number 16544). None of the eyes in this study were used to develop either the R factor or the ALxK method.
Preoperative cataract surgery keratometry and axial length values were measured using the IOL Master 500 (Carl Zeiss Meditec, Dublin, CA) and patients’ postoperative refractions were obtained through both subjective and objective methods. Patients with a best corrected visual acuity less than 20/20, with moderate and severe dry eye, pterygium, eye surface diseases, unknown refraction after cataract extraction, unknown implanted IOL power, with refractive surgery different from myopia or refractive techniques other than PRK and LASIK were excluded from the study.
After applying the inclusion and exclusion criteria, 91 eyes of 91 patients were selected for the study (group A). This group presented the following parameters: keratometry 37.99 ± 2.59 D (median: 38.32 D), axial length 27.71 ± 2.03 mm (median: 27.50 mm).
The zeroing of the mean error (ME) was not achievable for all the selected eyes, because in some of them the implanted IOL constant but not the model was known or the IOL models were implanted in less than 3 patients, making the zeroing unreliable. This benchmark resulted in the selection of a 68 eyes sample (group B) that was appropriate for zeroing out the mean error. Group B had these parameters: keratometry 37.71±2.50 D (median: 38.01 D), axial length 28.02±2.01 mm (median: 27.91 mm). Other characteristics of both Groups are reported in
Table 1.
Because ME error reflects the systematic bias of a method, checking its difference from zero was performed before zeroing it out [23 (
link)].
To zero out the mean error, the Excel software (Microsoft Corporation) was utilized and the following steps were performed:
In both A and B groups, the following absolute values were calculated for both R factor and ALxK methods:
Moreover, the parameter AL*K, where AL = axial length and K = mean keratometry value, was identified. Each group was then divided into two subpopulations, based on the AL*K value:
ALMA method was obtained combining R Factor results when AL*K <1060 and the ALxK results when AL*K> 1060. ALMA, R Factor and ALxK formulas in A and B groups were compared.
Descriptive statistics, performed with the Excel software (Microsoft Corporation), were used to describe population’s characteristics and IOL power calculation’s accuracy. Statistical analysis was performed with SPSS 23.0 (SPSS, Inc., Chicago, IL). The normality of data was examined by the Kolmogorov-Smirnov test before zeroing out the mean error. For screening whether the ME was significantly different from zero, one-sample T-test or Wilcoxon-signed-rank test were used. The Wilcoxon-signed-rank test was performed to compare the median absolute errors of the different methods analyzed in group A. Bootstrapped estimates were applied to perform T tests and confidence intervals within group B, as per Hoffer et al. [26 (
link)]. Bootstrapped estimates were preferred to non-parametric test because when transforming the data the older methods established on ranks tend to be underpowered; they tend to be less likely to detect a statistically significant difference, with the high risk running into a type II error [26 (
link)]. A P value of less than 0.05 was considered statistically significant.
Rosa N., Cione F., Pepe A., Musto S, & De Bernardo M. (2020). An Advanced Lens Measurement Approach (ALMA) in post refractive surgery IOL power calculation with unknown preoperative parameters. PLoS ONE, 15(8), e0237990.