1. Introduction
Ophthalmology residency programs are faced with the challenge of defining and measuring surgical competency [
1,
2]. To this end, competency based curricula have been developed. Standardized, objective competency based evaluation of surgical skills is well established using defined tasks and skills assessment real-time in the operating room and wet-labs [
3,
4,
5].
Evidence based practices are clinical decisions based on using the best available clinical data. For quality improvement of patient care and to reduce variability of patient outcome, evidence based practice is necessary. It is recommended that educational curricula train health care students in evidence based practice [
6]. However, to our knowledge, evidence based data used for quality improvement of patient outcomes are missing from the evolution of the formalized teaching of modern cataract surgery [
7]. Evidence based optimization of intraocular lens (IOL) constants is essential for quality improvement of patient refractive outcomes [
8,
9,
10,
11]. Therefore, the advantages and main objective of our study are to educate ophthalmology residents in evidence based practice, which should improve the quality of health care. Specifically, our study uses available data to perform evidence based optimization of IOL calculation formula constants and minimize systematic bias of the effective lens position (ELP) [
8,
9,
12]. Importantly, the evidence based results are used proactively, and these results are evaluated.
2. Materials and Methods
2.1. Subjects
This is a retrospective study of 431 patients, who agreed to undergo routine cataract surgery performed by 21 different novice resident surgeons during their first or second year in the ophthalmology residency program at the University of North Carolina at Chapel Hill, School of Medicine, Department of Ophthalmology from May 2017 through August 2023. Senior residents were not included. Inclusion criteria were age greater than 18 years, a clinically significant cataract, and agreeing to have an ophthalmology resident as primary surgeon. Postoperative measurements were at approximately one month. Patients with previous ocular surgery, intraoperative and postoperative complications and comorbidities that would likely affect visual acuity outcome were excluded. The first ten cases for each resident were excluded to act as a buffer for novice surgeons to become acclimated to routine cataract surgery. For bilateral surgeries, only the first operated eye was included to support random laterality.
The University of North Carolina Office of Human Research and Ethics issued a waiver of informed consent in its entirety as well as a waiver of HIPAA authorization. This study was in adherence to the tenets of the Declaration of Helsinki as well as regulations established by HIPAA.
For the first 167 patients, biometry was performed using partial coherence interferometry (PCI) with the IOLMaster 500 (Carl Zeiss Meditec AG, Dublin, CA, USA). For the subsequent 264 patients, biometry was performed using SWEPT Source OCT (IOLMaster 700, Carl Zeiss Meditec AG, Dublin, CA, USA) and a surgically induced astigmatism of 0.12 D.
2.2. Surgical Technique
All residents were taught by the same experienced attending surgeon (KLC) and used the same surgical technique. A fixation ring and a 1.15 slit knife created the side-port incision. Healon 5
® (Johnson&Johnson Surgical Vision, Santa Ana, CA, USA) was injected. A 2.2 mm keratome and fixation ring created the temporal, almost clear corneal incision. A cystitome and Giannetti capsulorhexis forceps created a continuous curvilinear capsulorhexis. After hydrodissection and hydrodelineation, coaxial phacoemulsification (Whitestar Signature
®PRO Johnson&Johnson Surgical Vision, Santa Ana, CA, USA) was performed. A divide and conquer technique was used moving to an appropriate chopping technique when skills were appropriate. Healon
® (Johnson&Johnson Surgical Vision, Santa Ana, CA, USA) was injected followed by injection and placement into the capsular bag of a monofocal Tecnis
® ZCB00 (Johnson&Johnson Surgical Vision, Santa Ana, CA, USA) [
13]. The Healon
® was aspirated, and the incisions hydrated. Postoperatively, patients used a combination of drops (antibiotic, corticosteroid, non-steroid anti-inflammatory).
2.3. IOL Calculation and Optimization
For the Tecnis ZCB00, the IOLMaster 500 has a built-in, default Haigis formula with non-optimized constants. For the first 216 patients, from 11 different residents, this default Haigis formula was used for surgical planning with the IOLMaster 500, 167 patients, and with the IOLMaster 700, 49 patients.
Using the initial 128 cases, a built-in function of the IOLMaster 500 optimized a0 such that the postoperative refractive spherical equivalent (SEQ) should be closer to predicted. This built-in function specifically only optimized the a0 constant. This a0-optimized constant, with the non-optimized a1 and a2, proactively calculated IOL power for surgical planning for the subsequent 94 surgeries of seven residents.
To optimize all three Haigis constants, the postoperative SEQs for all the initial 216 patients were used. A multiple linear regression was performed to back-calculate the ELP term in the Haigis that would bring the SEQ closer to its predicted. These a0/a1/a2-optimized constants were then used proactively in surgical planning for the subsequent and final 121 surgeries for 11 residents in the study.
To evaluate the efficiency of the optimization process, biometrics from these 121 a0/a1/a2-optimized cases were input into the online Barrett Universal II (Barrett UII)
https://calc.apacrs.org/barrett_universal2105/ (accessed on 30 January 2024), Kane
https://www.iolformula.com/ (accessed on 30 January 2024) and Hill-RBF
https://rbfcalculator.com/online/index.html (accessed on 30 January 2024) calculators. The manufacturer’s A constant of 119.3 (Kane and Hill-RBF) and lens factor (LF) of 2.09 (Barrett UII) were used [
13]. The predicted SEQ that corresponded to the IOL power that was actually implanted was used for comparisons.
The ELP increment needed to reduce systematic bias in the a0/a1/a2-optimized surgeries (n = 121) was calculated using the analytical function of a thick-lens pseudophakic model [
12,
14]. The ELP increment was used to update manufacturer’s A constant and LF for the Tecnis ZCB00. For this a0/a1/a2-optimized group, the updated A constant and LF were input into the three online calculators to produce the predicted SEQ for the IOL power implanted.
2.4. Outcome Measures
Refractive prediction performance was assessed using the arithmetic mean prediction error (AME), mean absolute prediction error (MAE), median absolute prediction error (MedAE), and root mean square prediction error (RMSE) [
11,
15,
16]. RMSE has been increasingly adopted into modern IOL formula studies as an alternative to standard deviation (SD) and was used for subgroup analysis, as recommended by Dr. Holladay [
15,
16]. Postoperative spherical equivalent (SEQ) prediction accuracy was further characterized by calculating the percentage of eyes within ±0.25 D, ±0.50 D, and ±1.00 D of the predicted SEQ. Best corrected visual acuity (BCVA) between groups was compared.
2.5. Statistical Analysis
Data were analyzed using SPSS Statistics for Windows (version 27.0, SPSS, Inc., Chicago, IL, USA). The Shapiro-Wilk test was used to check data distributions for normality. The Wilcoxon signed-rank test was used to compare differences. The bootstrap-t method with Holm correction was used to compare RMSE between groups. A p-value less than 0.05 was considered statistically significant. Comparisons between the clinical outcomes of the non-optimized, a0-optimized, and a0/a1/a2-optimized groups were performed. Comparisons between the a0/a1/a2-optimized group and the online calculators were performed.
3. Results
The average age of 431 patients was 62.73 ± 10.15 years (range 26 to 89 years). Of the 262 females and 169 males included, 47% received initial surgery on the left eye and the remaining 53% on the right eye. The average follow-up for the non-optimized, a0-optimized, and a0/a1/a2-optimized groups were 37 ± 23 days, 40 ± 24 days, and 45 ± 27 days, respectively.
The default Haigis constants from the IOLMaster 500 are listed in
Table 1. The a0-optimized constant and the a0/a1/a2-optimized constants are listed in
Table 1.
The mean biometrics (AL, K, ACD) for each group are listed in
Table 2. The average implanted IOL powers for each group are listed in
Table 2.
Table 3,
Table 4 and
Table 5 show the clinical effect of Haigis constant optimization used proactively for surgical planning. The absolute SEQ decreased significantly compared to the non-optimized (0.49 ± 0.57 D) to the a0-optimized group (0.32 ± 0.37 D) (
p = 0.002) (
Table 3). Similarly, the absolute SEQ of the a0/a1/a2-optimized group (0.22 ± 0.34 D) was significantly reduced from the non-optimized and a0-optimized groups (
p < 0.001,
p = 0.018), respectively (
Table 3). Optimization increased the percentage of eyes within ± 0.50 D from 65.74% (non-optimized) to 74.47% (a0-optimized) to 95.04% (a0/a1/a2-optimized) (
Table 4).
Table 5 shows the improved outcomes of optimization on the AMEs and MAEs. Using the non-optimized Haigis formula, the AME was −0.22 ± 0.54 D, and the MAE was 0.44 ± 0.38 D. Using the a0-optimized constant, significantly reduced the MAE to 0.35 ± 0.37 D (
p = 0.009); the AME was reduced, −0.11 ± 0.50 D, but not significantly (
p = 0.208). Compared to the non-optimized and the a0-optimized groups, the a0/a1/a2 optimization further significantly reduced the AME to 0.03 ± 0.29 D and MAE to 0.19 ± 0.22 D (
p = 0.026 and
p < 0.001), respectively.
Table 6 shows the distribution of preoperative and postoperative BCVA outcomes for the non-optimized, a0-optimized, and a0/a1/a2-optimized Haigis formulas. Across all three groups, a clear improvement in postoperative visual acuity was observed following optimization. The percentage of eyes achieving excellent BCVA (20/20–20/25) increased substantially, rising from 71.49% postoperatively in the non-optimized group, to 78.72% and 79.34% in the a0-optimized and a0/a1/a2-optimized groups, respectively. Simultaneously, the incidence of eyes with severely reduced postoperative BCVA (20/200 or worse) declined with each step of optimization, from 4.71% in the non-optimized group, to 2.13% in the a0-optimized group, and 0% in the a0/a1/a2-optimized group. Additionally, the proportion of eyes within the intermediate visual acuity ranges (20/30–20/70 and 20/71–20/150) decreased across all groups postoperatively, indicating a redistribution of patients into higher acuity brackets whilst minimizing poor outcomes.
Table 7 compares the MAEs of the a0/a1/a2-optimized data set with non-updated and updated A constant and LF for the online calculators (n = 121 for each). The change in ELP was −0.025 mm, and base ACD was 5.78 mm [
12]. Therefore, the updated ACD is 5.755, and the updated A constant is 119.266 (A = 119.27 in online calculators, which converts to LF = 2.03 for the Barrett UII). Using the manufacturer’s LF for the Barrett UII the A constant for the Kane and Hill-RBF, the MAEs (0.25 ± 0.31 D, 0.24 ± 0.30 D, 0.23 ± 0.32 D, respectively) were slightly more than but not significantly different from the MAE of the a0/a1/a2-optimized group (0.19 ± 0.22 D) [
13]. Optimization of the ELP to update the A constant and LF resulted in the MAEs for the Barrett UII, Kane, and Hill-RBF (0.21 ± 23 D, 0.21 ± 0.21 D, 0.21 ± 0.22 D) to more closely approach the MAE for the a0/a1/a2-optimized group.
Table 8 compares RMSE across all formula groups, including the online calculators with non-updated and updated A constant and LF (n = 121 for each online calculator). For the Haigis, RMSE progressively decreased with increasing levels of optimization, from 0.580 in the non-optimized group to 0.506 in the a0-optimized group, and 0.289 in the a0/a1/a2-optimized group (
Table 8). The a0/a1/a2-optimized group significantly outperformed both the non-optimized (
p < 0.001) and a0-optimized (
p = 0.0019) groups.
The RMSE for the a0/a1/a2-optimized Haigis formula was the lowest across all formulas and was significantly lower than the Barrett UII, Kane and Hill-RBF formulas (manufacture’s A constant and LF) (
p < 0.001,
p < 0.001,
p = 0.004, respectively), for the same eyes (n = 121). However, for the same eyes (n = 121), the a0/a1/a2-optimzed Haigis RMSE was not significantly lower than the ELP updated Barrett UII, Kane, or Hill-RBF formulas (
p = 0.145,
p = 0.158,
p = 0.171, respectively) (
Table 8).
Among the online formulas, the Kane formula had the lowest RMSE of 0.379, however it was not significantly lower than the Barrett UII or Hill-RBF formulas (
p = 0.578 and
p = 0.245, respectively). Using the updated A constant and LF in these formulas yielded the same results. The updated Kane formula again had the lowest RMSE of 0.294, and it was again not significantly different from either the updated Barrett UII or updated Hill-RBF formulas (
p = 0.920 and
p = 0.423, respectively) (
Table 8).