Journal of Refractive Surgery

Original Article 

Comparison of Visual Outcomes of Extended Depth of Focus Lenses in Patients With and Without Previous Laser Refractive Surgery

Karen L. Christopher, MD; D. Claire Miller, BS; Jennifer L. Patnaik, PhD; Anne M. Lynch, MD, MSPH; Richard S. Davidson, MD; Michael J. Taravella, MD

Abstract

PURPOSE:

To compare visual outcomes of eyes with and without previous laser refractive surgery that received an extended depth of focus intraocular lens during cataract surgery.

METHODS:

This was a retrospective review of all eyes implanted with an extended depth of focus intraocular lens by two surgeons. Preoperative demographic and eye examination information were collected, as well as postoperative refraction, uncorrected distance visual acuity, and Visual Function Index (VF-14) questionnaire responses. Medical records were reviewed postoperatively to collect the number of patients who required a refractive touch-up or lens exchange.

RESULTS:

Most patient eyes (187 of 215, 87%) had no prior refractive surgery, and there was no significant difference in preoperative characteristics between this group and the 28 eyes that did have previous laser refractive surgery. Postoperatively, most patients had a refractive error within ±0.50 diopters (D) (79% without vs 77% with previous laser refractive surgery, P = .40). Although more patients in the group without previous laser refractive surgery achieved 20/20 uncorrected distance visual acuity (UDVA) (56.8% versus 28.6%, P = .01), the majority in both groups achieved 20/25 or better UDVA (79.5% versus 85.7% for without versus with previous laser refractive surgery, P = .42). Postoperative subjective visual function score was also similar between the two groups as measured by the VF-14 questionnaire (86.9 vs 79.4, P = .15). Few patients required refractive surgery enhancement in either group (9 of 187 (4.8%) versus 1 of 28 (3.6%) for without versus with previous laser refractive surgery, P = .77).

CONCLUSIONS:

The data suggest that extended depth of focus lens implantation can have successful results for patients with prior laser refractive surgery.

[J Refract Surg. 2020;36(1):28–33.]

Abstract

PURPOSE:

To compare visual outcomes of eyes with and without previous laser refractive surgery that received an extended depth of focus intraocular lens during cataract surgery.

METHODS:

This was a retrospective review of all eyes implanted with an extended depth of focus intraocular lens by two surgeons. Preoperative demographic and eye examination information were collected, as well as postoperative refraction, uncorrected distance visual acuity, and Visual Function Index (VF-14) questionnaire responses. Medical records were reviewed postoperatively to collect the number of patients who required a refractive touch-up or lens exchange.

RESULTS:

Most patient eyes (187 of 215, 87%) had no prior refractive surgery, and there was no significant difference in preoperative characteristics between this group and the 28 eyes that did have previous laser refractive surgery. Postoperatively, most patients had a refractive error within ±0.50 diopters (D) (79% without vs 77% with previous laser refractive surgery, P = .40). Although more patients in the group without previous laser refractive surgery achieved 20/20 uncorrected distance visual acuity (UDVA) (56.8% versus 28.6%, P = .01), the majority in both groups achieved 20/25 or better UDVA (79.5% versus 85.7% for without versus with previous laser refractive surgery, P = .42). Postoperative subjective visual function score was also similar between the two groups as measured by the VF-14 questionnaire (86.9 vs 79.4, P = .15). Few patients required refractive surgery enhancement in either group (9 of 187 (4.8%) versus 1 of 28 (3.6%) for without versus with previous laser refractive surgery, P = .77).

CONCLUSIONS:

The data suggest that extended depth of focus lens implantation can have successful results for patients with prior laser refractive surgery.

[J Refract Surg. 2020;36(1):28–33.]

Extended depth of focus intraocular lenses (EDOF IOLs) are becoming an increasingly popular technique to support spectacle independence following cataract surgery. However, patients report glare, halos, and starbursts at a much higher rate with EDOF IOLs than with monofocal lenses.1,2 For patients with previous laser refractive surgery (laser-assisted in situ keratomileusis [LASIK] or photorefractive keratectomy [PRK]) who are already known to have corneas with above average higher order aberrations and dysphotopsias,3–7 the combination of their previously ablated cornea with an EDOF IOL could have an even more negative impact on quality of vision following cataract surgery. Furthermore, previous laser refractive surgery causes difficulty in predicting IOL strength,8–10 which can lead to refractive surprises and inferior outcomes in patients expecting spectacle independence with presbyopia-correcting lenses.

Prior studies of multifocal lenses in patients who had LASIK report generally good outcomes with high patient satisfaction and good visual acuity.11–15 However, to date there are no published studies directly comparing subjective and objective outcomes of EDOF IOLs in patients with and without previous laser refractive surgery. This study evaluated the outcomes of EDOF lens implantation in patients with and without previous laser refractive surgery.

Patients and Methods

We conducted a retrospective review of all patients at our institution who underwent cataract surgery with EDOF lens implantation (TECNIS Symfony ZXROO or TECNIS Symfony Toric ZXT150, ZXT225, ZXT300, ZXT375; Johnson & Johnson, Santa Ana, CA) between October 2016 and December 2017 by two surgeons (MJT, RSD). The study was approved by the Colorado Multiple Institutional Review Board. Demographic information, history of LASIK, PRK, or radial keratotomy, and preoperative corrected distance visual acuity (CDVA) were collected from the electronic medical record. All surgeries were performed using the standard phacoemulsification technique and the surgeon chose whether or not to use a femtosecond laser and/or intraoperative aberrometry. Lens selection for eyes without previous laser refractive surgery was based on IOL-Master 500 measurements (Carl Zeiss Meditec, Jena, Germany) and the surgeon's choice of a formula, with or without influence from intraoperative aberrometry. Lens selection for eyes that had previous laser refractive surgery was accomplished using the online American Society of Cataract and Refractive Surgery (ASCRS) post-refractive calculator ( http://iolcalc.ascrs.org/) and the surgeon's choice of formula, with or without influence from intraoperative aberrometry.

Postoperative uncorrected distance visual acuity (UDVA), CDVA, manifest refraction, Visual Function Index (VF-14) questionnaire responses, and need for laser refractive enhancement (LASIK or PRK) or lens exchange were collected through the most recent ophthalmology visit available. Refractions at 21 to 365 days postoperatively with the best visual acuity were collected. When multiple refractions had the same best visual acuity, these refractions were averaged. Patients with previous laser refractive surgery were compared to patients without previous laser refractive surgery with the Fisher's exact test for categorical variables and t test or Wilcoxon rank sum test for continuous variables. Comparisons of outcomes for eyes in each group were performed using linear or logistic regression with general estimating equations (GENMOD procedure) to account for the intrasubject correlation. Additional subanalysis was performed on patients with previous radial keratotomy.

Results

Data were collected on 215 eyes from 119 patients, excluding four eyes of two patients who had previous radial keratotomy that will be discussed later. Baseline characteristics for patients with previous laser refractive surgery versus those without did not differ by gender, race/ethnicity, or age. Preoperative CDVA was also similar between the two groups (Table 1). Intraoperative aberrometry and a femtosecond laser were used in approximately half and two-thirds of the surgeries, respectively, as dictated by surgeon preference, and did not differ significantly between the two groups (Table 2). Figure 1 shows the visual and refractive outcomes. Postoperative refractive error was within ±0.50 diopters (D) of plano in 78% of eyes without previous laser refractive surgery and 77% of eyes with previous laser refractive surgery (P = .40) (Figure 1C). The majority of both groups achieved 20/25 or better UDVA (79.5% vs 85.7% for without refractive surgery history vs with, P = .42) (Table 2), although the percentage who achieved 20/20 or better visual acuity was higher in the no previous laser refractive surgery group (56.8% vs 28.6%, P = .01) (Figure 1A).

Preoperative Characteristics for Patients and Preoperative CDVA for Eyes

Table 1:

Preoperative Characteristics for Patients and Preoperative CDVA for Eyes

Postoperative Outcomes of Eyes (N = 215)

Table 2:

Postoperative Outcomes of Eyes (N = 215)

(A) Uncorrected distance visual acuity (UDVA). (B) UDVA versus corrected distance visual acuity (CDVA). (C) Spherical equivalent refractive accuracy. (D) Refractive cylinder. D = diopters

Figure 1.

(A) Uncorrected distance visual acuity (UDVA). (B) UDVA versus corrected distance visual acuity (CDVA). (C) Spherical equivalent refractive accuracy. (D) Refractive cylinder. D = diopters

The postoperative VF-14 questionnaire score was 86.9 ± 13.8 for patients without previous laser refractive surgery (range: 45.8 to 100) compared to 79.4 ± 17.3 (range: 44.6 to 98.2) for patients with previous laser refractive surgery (P = .15). The questions on the postoperative VF-14 questionnaire that had the greatest difference between the no previous laser refractive surgery group and the previous laser refractive surgery group surveyed the patient's ability to read small print (mean: 2.3 vs 1.6, P = .17), read a newspaper or a book (mean: 2.8 vs 2.0, P = .13), and do fine handwork (mean: 2.9 vs 1.75, P = .18). No significant difference was detected, but this VF-14 questionnaire analysis was limited by incomplete data, with surveys collected on only 37.1% of patients without previous laser refractive surgery and 66.7% of patients with previous laser refractive surgery.

At 12 to 26 months of follow-up, 10 eyes had undergone laser refractive surgery enhancements to improve their vision (one in the previous laser refractive surgery group and nine in the no previous laser refractive surgery group, P = .77), and no patient had undergone lens exchange surgery.

We did not include in this analysis four eyes of two patients who underwent implantation of the EDOF IOL after previous radial keratotomy surgery. Both had four-cut radial keratotomy in each eye with minimal reported daily visual fluctuation preoperatively. The postoperative refractive error was less than 0.50 D in both eyes of one patient and greater than 1.00 D in both eyes of the other patient. UDVA was worse than 20/25 in all four eyes, although uncorrected near acuity was J2 or better in all four eyes. One patient was happy with the results in both eyes, and the other underwent laser refractive surgery enhancement in both eyes.

Discussion

The results of our study suggest that even with direct comparison between patients with and without previous laser refractive surgery, EDOF lens implantation can have successful results. Although our study may not have been powered to detect subtle differences between our two study groups, the goal was to examine outcomes in this distinct group of patients after refractive surgery receiving an EDOF lens soon after its introduction to clinical practice. Findings from this study showed no large differences in visual outcomes for patients with previous laser refractive surgery, but additional studies with larger sample sizes are warranted.

Although differences in residual postoperative refractive error did not seem to play a large role in our study, strategies for IOL selection vary significantly across practices, especially for eyes with previous laser refractive surgery. Accuracy of IOL selection in eyes that had refractive surgery continues to be challenging even with the development of new formulas and techniques. Multiple formulas available on the ASCRS website ( http://iolcalc.ascrs.org/) have been used to improve outcomes in eyes after refractive surgery. Recent studies have suggested that the Barrett True-K formula yields good outcomes for both monofocal16 and multifocal17,18 IOLs. Alternatively, intraoperative aberrometry has also been used to improve the accuracy of lens selection in eyes after refractive surgery.19,20 With ongoing refinement of these techniques, the differences in IOL selection accuracy for eyes with or without previous laser refractive surgery will likely continue to decrease and minimize the concern for refractive surprise as a deterrent for using EDOF lenses in eyes after refractive surgery.

This study was not designed to compare different lens power calculation techniques used by the different surgeons involved in this study, but it is possible that standardizing IOL formulas, lens constant optimization, and use of intraoperative aberrometry may have enhanced refractive outcomes even further. Although the mean absolute postoperative spherical equivalent did tend to be slightly closer to zero in the group with no previous laser refractive surgery, this difference did not reach statistical significance and is unlikely to be of clinical significance because most were still within ±0.50 D of plano for both groups. That being said, nearly twice as many patients in the group without previous laser refractive surgery had a final refraction between −0.13 and +0.13 D (35.8% vs 19.2%).

Analysis of subjective outcomes was hindered by limited available data. Although there was not a significant difference in postoperative VF-14 questionnaire responses between the groups with and without previous laser refractive surgery, it is certainly possible that a larger data set would lead to a different result. The mean VF-14 questionnaire response in the group with previous laser refractive surgery was nearly eight points lower, which could be indicative of greater problems with glare and halos, night driving, or reading small print if this difference persists with a larger sample size. The questions that tended to show decreased postoperative visual function in the group with previous laser refractive surgery were those that dealt with heightened visual acuity needs for near activities (reading small and regular print and fine hand-work), but none of these differences reached statistical significance in our small sample size. Additionally, it is unclear how much of this difference might be explained by the non-statistically significant more myopic mean refractive result in the group without previous laser refractive surgery, which may have aided those patients with near visual tasks. Either way, near visual acuity results in patients after refractive surgery should be investigated further.

An additional crucial element to consider before using EDOF lenses in patients after refractive surgery is the need for a generally well-centered and regular-appearing ablation pattern on the cornea. At our institution, this is typically assessed with review of the patient's topography and inquiry as to whether the patient was satisfied with the quality of vision following the laser refractive surgery. The patients included in this study all had well-centered, regular ablation patterns and were generally satisfied with the quality of their vision between the time of the laser refractive surgery and the time their cataract began developing. Development of objective criteria to assess the corneal ablation profile would be useful, and it is a weakness of our study that we have no objective criteria with which our patients were graded. However, the results of this study should not be generalized to those who never gained good visual quality following their refractive surgery, had decentered ablations, or showed signs of corneal ectasia. Similarly, EDOF lenses should be used with caution in eyes with other ocular pathology (macular drusen, cornea guttae, epiretinal membrane, or glaucoma), and our study population involved only those patients with otherwise unremarkable ocular examinations.

Due to the retrospective nature of our study, we were limited in what measures of postoperative subjective and objective visual function we could collect. Further studies specifically investigating uncorrected near visual acuity, visual quality, and incidence of visual side effects such as glare and halos in this subgroup of patients having cataract surgery are warranted, as are investigations into which patients with previous radial keratotomy are most likely to do well with these lenses.

References

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Preoperative Characteristics for Patients and Preoperative CDVA for Eyes

CharacteristicNo History of Prior Laser Refractive SurgeryHistory of Prior Laser Refractive SurgeryP
No. of patients/eyesa103/18715/28
Gender.38b
  Female68 (66.0%)12 (80.0%)
  Male35 (34.0%)3 (20.0%)
Race/ethnicity.87b
  White90 (87.4%)14 (93.3%)
  Hispanic2 (1.9%)0
  African American1 (1.0%)0
  Asian3 (2.9%)0
  Other4 (3.9%)0
  Unknown3 (2.9%)1 (6.7%)
Age, years.61c
  Mean ± SD67.5 ± 8.466.3 ± 7.9
  Range34 to 9152 to 75
Preoperative CDVA.93d
  20/30 or better132 (70.6%)20 (71.4%)
  Worse than 20/3055 (29.4%)8 (28.6%)

Postoperative Outcomes of Eyes (N = 215)

CharacteristicNo History of Prior Laser Refractive SurgeryHistory of Prior Laser Refractive SurgeryP
No. of eyes187 (87.0%)28 (13.0%)
Femtosecond laser used135 (72.2%)18 (64.3%).53a
Intraoperative aberrometry used89 (47.6%)17 (60.7%).32a
Mean ± SD SE (D)n = 159; −0.25 ± 0.37n = 26; −0.14 ± 0.45.37b
Mean ± SD absolute SE (D)0.34 ± 0.290.37 ± 0.30.68b
Postoperative UDVA
  20/20 or better105 (56.8%)8 (28.6%).01a
  20/25 or better147 (79.5%)24 (85.7%).42a
  Missing2 (1.1%)0 (0%)
Postoperative laser enhancement9 (4.8%)1 (3.6%).77a
Authors

From the Department of Ophthalmology, University of Colorado School of Medicine, Aurora, Colorado.

Dr. Taravella is a scientific consultant for Johnson & Johnson Vision and VISX. The remaining authors have no financial or proprietary interest in the materials presented herein.

AUTHOR CONTRIBUTIONS

Study concept and design (AML, RSD, MJT); data collection (KLC, DCM, AML, MJT); analysis and interpretation of data (KLC, JLP, AML); writing the manuscript (KLC); critical revision of the manuscript (DCM, JLP, AML, RSD, MJT); statistical expertise (JLP); supervision (AML, MJT)

Correspondence: Karen L. Christopher, MD, Department of Ophthalmology, University of Colorado School of Medicine, 1675 Aurora Court, MS 731, Aurora, CO 80045. E-mail: karen.christopher@cuanschutz.edu

Received: July 06, 2019
Accepted: November 19, 2019

10.3928/1081597X-20191204-01

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