Visual Performance after a Unilateral or Bilateral Implantation of Enlarged Depth-of-Focus Intraocular Lens in Patients with Cataract: A Prospective Clinical Trial

Choi, Se Hyun; Lee, Hyo kyung; Yoon, Chang Ho; Kim, Mee Kum

doi:https://doi.org/10.1155/2019/2163809

Journal of Ophthalmology

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Abstract Introduction Materials and Methods Results Discussion Conclusions Data Availability Conflicts of Interest References Copyright Related Articles

Clinical Study | Open Access

Volume 2019 | Article ID 2163809 | https://doi.org/10.1155/2019/2163809

Visual Performance after a Unilateral or Bilateral Implantation of Enlarged Depth-of-Focus Intraocular Lens in Patients with Cataract: A Prospective Clinical Trial

Se Hyun Choi,^1,2Hyo kyung Lee,^1,2Chang Ho Yoon,^1,2and Mee Kum Kim^1,2

Academic Editor: Alessandro Meduri

Received12 Dec 2018

Accepted14 Feb 2019

Published04 Mar 2019

Abstract

Purpose. To investigate visual performances after a unilateral or bilateral implantation of enlarged depth-of-focus intraocular lens in patients with cataract. Methods. In this prospective study, uneventful phacoemulsification and TECNIS┬« Symfony intraocular lens implantation were performed in 20 eyes of 17 patients. At postoperative 1, 4, and 12ŌĆēweeks, the logarithm of the minimal angle of resolution visual acuity at far, intermediate, and near distances and the spherical equivalent in manifest refraction and automated refraction were measured. A questionnaire was used to investigate glare, spectacle dependency, and satisfaction at 12ŌĆēweeks. The mean numerical error and mean absolute error were compared between intraocular lens formulas to assess the best-fit formula. Results. The logarithm of the minimal angle of resolution visual acuity significantly improved to 0.02 at far, 0.02 at intermediate, and 0.27 at near distances at 12ŌĆēweeks (). Spherical equivalent was ŌłÆ0.79ŌĆēD on automated refraction and was significantly lower than ŌłÆ0.26ŌĆēD measured on manifest refraction. PatientsŌĆÖ satisfaction score was 9.06, 8.94, and 6.65 for far, intermediate, and near distances, respectively. Near glasses were required in 5 patients and 2 patients complained of photic phenomenon. Visual performances were not significantly different between bilateral and unilateral implanted patients. No patients reported bilateral imbalance due to unilateral surgery. The mean numerical error was closest to 0ŌĆēD using the Barrett Universal II formula. The mean absolute error was not significantly different between these formulas. Conclusion. Unilateral or bilateral implantation of the enlarged depth-of-focus intraocular lens seems to be equally effective in improving visual performances in patients with cataract.

1. Introduction

With the advancement of the intraocular lens (IOL), cataract surgery has become an operation not only to replace an opaque crystalline lens with a clear intraocular lens but also a procedure to correct the refractive error and presbyopia [1, 2]. Initially, bifocal IOLs were available, but as the demand for intermediate vision inpatients using computers increased, trifocal IOLs became popular [3, 4]. However, bifocal or trifocal IOLs have limitation that the working distances between these fixed focal points are involved in suboptimal visual acuity [5ŌĆō7]. A newly developed enlarged depth-of-focus (EDOF) IOL may provide better optical quality on the whole addition range than fixed multifocal IOLs with a proprietary achromatic diffractive surface designed to correct chromatic aberration and a echelette feature to extend the range of vision [5, 8].

Recently, a few reports comparing TECNIS┬« Symfony IOL with other multifocal IOLs have been published and reported good intermediate visual outcomes compared to other IOLs [9, 10]. However, most previous studies included only patients who underwent bilateral surgery and did not analyse the refractive changes [11, 12]. In addition, few reports investigated the subjective satisfaction with unilateral bifocal IOL implantation but not with EDOF lens [13, 14]. This study aimed to report visual performances including refractive outcomes, subjective satisfaction, and spectacle independence in patients undergoing unilateral or bilateral TECNIS┬« Symfony IOL implantation.

2. Materials and Methods

2.1. Patients

This prospective study adhered to the tenets of the Declaration of Helsinki and was approved by the Institutional Review Board of Seoul National University Hospital (IRB no. 1612-133-820). The study was conducted from February 2017 to May 2018. Twenty eyes of 17 patients who visited ophthalmology outpatient clinic of Seoul National University Hospital for the cataract surgery and were willing to participate in the study were included. All included participants signed a consent form.

Inclusion criteria were as follows: (1) patients with cataracts confirmed by slit-lamp examination preoperatively; (2) patients who underwent uneventful unilateral or bilateral cataract surgery with implantation of the EDOF IOL (TECNIS┬« Symfony or TECNIS┬« Symfony Toric); (3) age of Ōēź16ŌĆēyears; (4) patients with regular corneal astigmatism of Ōēż0.75ŌĆēDiopter (D) for TECNIS┬« Symfony IOL and between 1.0 and 3.62ŌĆēD for TECNIS┬« Symfony toric IOL.

Exclusion criteria were as follows: (1) pregnant or nursing women; (2) presence of other ocular disease that may affect the stability of the lens capsule such as pseudoexfoliation syndrome, traumatic cataract, and Marfan syndrome; (3) presence of other ocular diseases that are expected to have a poor final visual acuity of <20/30 after the cataract surgery; (4) pupil abnormality; (5) white cataract; (6) systemic or ocular medication that may affect the visual acuity; (7) previous refractive surgery; and (8) patients participating in other clinical trials during the study.

2.2. Surgical Technique

All cataract surgeries were performed by a single surgeon (M.K.K.). After the conventional phacoemulsification through the temporal clear corneal incision, TECNIS┬« Symfony or TECNIS┬« Symfony Toric IOLs were implanted in the capsular bag. Postoperatively, topical fluorometholone acetate ophthalmic suspension (Flarex┬«, Alcon, Alcon Laboratories Inc., Fort Worth, TX, USA) were administered four times a day for 1ŌĆēweek, topical levofloxacin 0.5% (Cravit┬«, Santen Pharmaceutical, Osaka, Japan) eye drops were administered four times a day for 1ŌĆēmonth, and topical bromfenac sodium ophthalmic solution 0.1% (Bronuck┬«, Taejoon Pharm, Seoul, Korea) was instilled twice a day for 2ŌĆēmonths.

2.3. Clinical Evaluation

The primary outcomes of the study were improvement of visual acuity at near, intermediate, and far. Secondary outcomes included presence of photic phenomena and spectacle independence for daily tasks.

Corrected distance visual acuities (CDVA) were measured before the surgery, and 1, 4, and 12ŌĆēweeks after the surgery to evaluate the safety index. Uncorrected visual acuities (UCVA) were measured at far (5ŌĆēm), intermediate (66ŌĆēcm), and near (40ŌĆēcm) distances preoperatively, and then 1, 4, and 12ŌĆēweeks postoperatively. Snellen visual acuities were converted to the logarithm of minimal angle of resolution (LogMAR) for statistical analysis. Thorough ophthalmic examinations including intraocular pressure, slit-lamp examination, and keratometry were conducted at every follow-up.

Automated refraction (AR) and manifest refraction (MR) were performed at postoperative 1, 4, and 12ŌĆēweeks. The IOL master 700 (Carl Zeiss Meditec AG, Jena, Germany) was used to calculate SRK/T, Holladay 2, Haigis, and Hoffer Q formulas. The Barrett Universal II and Hill-RBF formulas were calculated by inputting the values measured by IOL master 700 measurements into the online software. The refraction prediction error was calculated as the difference between the actual postoperative manifest refraction and the predicted refraction for each formula. The mean numerical error (MNE) was defined as the arithmetic mean of the prediction errors, and the mean absolute error (MAE) was defined as the mean of the magnitude of the prediction errors.

At postoperative 4 and 12ŌĆēweeks, the contrast sensitivity test (VCTS 6500, Vistech Consultants Inc., Dayton, OH, USA) and ALC glare test (v1.3, ALC Clinic, Seoul, Korea) were performed as previously reported [15, 16].

To evaluate the patientsŌĆÖ subjective outcome, a questionnaire was used as previously described [11]. PatientŌĆÖs satisfaction score in near, intermediate, and far tasks was measured from 0 (unsatisfactory) to 10 (very satisfactory) at postoperative 4 and 12ŌĆēweeks. Patients were asked regarding their spectacle dependencies at near, far, and intermediate distances with 0%, 25%, 50%, 75%, and 100% of time. Photic phenomena were evaluated using an open question whether the patients had any problems with their vision such as glare or halos.

In order to increase compliance of the patients, each outpatient visit was informed in advance. All data were recorded in electronic medical charts, and all data were collected by two independent ophthalmologists.

2.4. Statistical Analysis

All statistical analyses were conducted using Prism software (GraphPad Prism version 7, Inc. La Jolla, CA, USA). To compare quantitative variable between the data at two time points or between unilateral and bilateral implantation, a nonparametric MannŌĆōWhitney U test was used, and to compare the changes over time within a group, the paired t-test was used. To compare two time points, Wilcoxon matched-pairs signed-rank test was used, and to compare three or more time points, repeated measures analysis of variance (rANOVA) was used. Data were presented as the meanŌĆē┬▒ŌĆēstandard deviation (SD), and the differences were considered significant at .

3. Results

A total of 20 eyes of 17 patients were enrolled, and all patients completed a 12-week follow-up. Among them, 3 patients (n = 6 eyes) underwent bilateral EDOF lens implantation and the other 14 patients underwent unilateral EDOF lens implantation. The demographic and preoperative data of patients are summarised in Table 1. Of the 14 patients who underwent unilateral surgery, the opposite eye was excluded because it did not meet the inclusion criteria. Two eyes were pseudophakic, 8 eyes were without significant cataract, 2 eyes had epiretinal membrane, 1 eye had severe astigmatism, and 1 eye had history of previous refractive surgery. The spherical equivalent (SE) of the opposite eyes was ŌłÆ0.26ŌĆē┬▒ŌĆē2.22ŌĆēD.

3.1. Visual Performances

Eighteen eyes (90%) showed uncorrected distance visual acuity (UDVA) of 20/25 or better at 12ŌĆēweeks postoperatively, and 14 eyes (70%) showed UDVA of 20/20 or better at postoperative 12ŌĆēweeks (Figure 1(a)). Fifteen eyes (75%) gained two or more lines of CDVA after the surgery, and only one eye (5%) lost one line postoperatively (Figure 1(b)). LogMAR UCVA was improved at far (, rANOVA), intermediate (, rANOVA), and near (, rANOVA) distances at postoperative day 1 compared with the values preoperatively and remained stable until 3ŌĆēmonths after the surgery (Figures 1(c)ŌĆō1(e)). No difference in LogMAR UCVA was observed between bilateral and unilateral group sat far (, MannŌĆōWhitney U test), intermediate (, MannŌĆōWhitney U test), and near (, MannŌĆōWhitney U test) distances at postoperative 12ŌĆēweeks (Figure 2(a)).

(a)

(b)

(c)

(d)

(e)

(a)

(b)

(c)

3.2. Refractive Errors

Preoperative spherical equivalent measured by MR was ŌłÆ1.74ŌĆē┬▒ŌĆē3.14ŌĆēD, and the postoperative spherical equivalent was ŌłÆ0.34ŌĆē┬▒ŌĆē0.32ŌĆēD, ŌłÆ0.31ŌĆē┬▒ŌĆē0.30ŌĆēD, and ŌłÆ0.26ŌĆē┬▒ŌĆē0.33 at postoperative 1, 4, and 12ŌĆēweeks, respectively. Eighteen eyes (90%) showed SE within ┬▒ 0.5ŌĆēD, and all eyes showed SE within ┬▒ 1.0ŌĆēD at 12ŌĆēweeks after the surgery (Figure 3(a)). Postoperative SE measured by AR shifted significantly toward myopic compared with SE measured by MR at postoperative 1 (, paired t-test), 4 (, paired t-test), and 12ŌĆēweeks (, paired t-test) (Figure 3(b)). The mean difference was ŌłÆ0.53ŌĆē┬▒ŌĆē0.30ŌĆēD for SE at postoperative 12ŌĆēweeks.

(a)

(b)

(c)

(d)

(e)

Figure 3

Refractive outcome after the implantation of TECNIS┬« Symfony IOL. (a) Histogram showing postoperative spherical equivalent (SE) refraction measured by manifest refraction at 1, 4, and 12ŌĆēweeks postoperatively. (b) Histogram showing the differences in SE between manifest refraction and automated refraction. (c) Histogram showing the percentage of eyes within ┬▒ 0.5 D and ┬▒ 1.0 D for the target refraction. (d) Histogram showing mean numerical error using SRK/T, Holladay 2, Haigis, Hoffer Q, Barrett Universal II, and Hill-RBF formulas. (e) Histogram showing mean absolute error using SRK/T, Holladay 2, Haigis, Hoffer Q, Barrett Universal II, and Hill-RBF formulas.

In three eyes with TECNIS┬« Symfony Toric IOL implantation, preoperative corneal astigmatism was measured as 2.30ŌĆē┬▒ŌĆē0.95ŌĆēD with IOL master, 1.90ŌĆē┬▒ŌĆē0.91ŌĆēD with topography, and 1.97ŌĆē┬▒ŌĆē0.84ŌĆēD with keratometry and decreased to residual refractive cylinder of 0.33ŌĆē┬▒ŌĆē0.29ŌĆēD at postoperative 12ŌĆēweeks.

All formulas met the benchmark criteria [17] for postoperative refraction results (Figure 3(c)). The Barrett Universal II formula had a highest (closest to 0ŌĆēD)MNE of ŌłÆ0.08ŌĆē┬▒ŌĆē0.35ŌĆēD, which was significantly higher than Hill-RBF (0.0002, rANOVA), SRK/T (0.0175, rANOVA) and Haigis (0.0190, rANOVA) formulas (Figure 3(d)). The Barrett Universal II formula also had the lowest MAE of 0.25ŌĆē┬▒ŌĆē0.25ŌĆēD but was not significantly different from other formulas (Figure 3(e)).

3.3. Contrast Sensitivity Test and Glare Test

Contrast sensitivity values at all spatial frequencies were within normal limits at 4 and 12ŌĆēweeks postoperatively. Contrast sensitivity increased to12 cycles per degree at postoperative 12ŌĆēweeks compared with that of the postoperative 4ŌĆēweeks (, paired t-test) (Figure 4(a)). Mean scores of the glare test was 15796.9ŌĆē┬▒ŌĆē8459.5 at postoperative 4ŌĆēweeks and 15418.4ŌĆē┬▒ŌĆē7788.3 at postoperative 12ŌĆēweeks. The difference between the two time points was not statistically significant (, Wilcoxon matched-pairs signed-rank test) (Figure 4(b)).

(a)

(b)

3.4. Patient Satisfaction, Spectacle Dependence, and Photic Phenomena

PatientsŌĆÖ satisfaction score was 9.06ŌĆē┬▒ŌĆē2.08 for far, 8.94ŌĆē┬▒ŌĆē1.30 for intermediate, and 6.65ŌĆē┬▒ŌĆē2.67 for near-distance vision at postoperative 12ŌĆēweeks. PatientsŌĆÖ satisfaction scores were significantly higher at far (, rANOVA) and intermediate (, rANOVA) distance vision than at near vision. No significant difference in patientsŌĆÖ satisfaction score was observed between bilateral and unilateral surgery groups at all distances (Figure 2(b)).

All patients did not need a spectacle at far and intermediate distances at 12ŌĆēweeks postoperatively. In near tasks, two of the unilateral surgery patients required wearing spectacles for <50% of the time, and two unilateral surgery patients and one bilateral surgery patient required spectacles for >50% of the time. No clinically significant difference in spectacle dependency was observed between unilateral and bilateral surgery groups (>0.9999, FisherŌĆÖs exact test) (Figure 2(c)).

Only two patients complained of glare at postoperative 12ŌĆēweeks. Only one patient reported bilateral imbalance due to unilateral surgery (7.2%).

4. Discussion

In the eyes implanted with TECNIS┬« Symfony IOL, the UCVA at far, intermediate, and near distances was significantly improved just a day after the surgery and well maintained for 3ŌĆēmonths. As with the previous results, [18, 19] which ranged from 0.08 to 0.00, excellent mean logMAR UDVA of 0.02ŌĆē┬▒ŌĆē0.11 was also obtained at 12ŌĆēweeks in our study. This confirms the ability of the EDOF IOL to gain near vision without sacrificing distance vision. The mean logMAR uncorrected intermediate visual acuity (UIVA) of 0.02 and uncorrected near visual acuity (UNVA) of 0.27 were also within the normal range of visual acuities as previously reported [19, 20]. Along with previous studies in which the logMAR UNVA ranged from 0.30 to 0.20, [21] the monocular UNVA in our study, when compared with monocular UNVA in other multifocal IOLs measured at 40ŌĆēcm, was inferior to that of +3.0ŌĆēD bifocal IOL, AcrySof┬« IQ ReSTOR┬« (Alcon Laboratories, Inc., Fort Worth, TX, USA), ranging from 0.15 to 0.05, [3, 10] but compatible with UNVA of 0.23 with AT Lisa┬« tri 839MP (Carl Zeiss Meditec AG, Jena, Germany) or 0.24 with Fine Vision IOL (Physiol, Liege, Belgium) [22, 23]. The TECNIS┬« Symfony IOL is considered to be better suited for patients who spend more time on intermediate-distance tasks, such as computer work, rather than near-distance tasks, such as reading or using mobile phones. In patients with a demand for near-field work that is closer than 40ŌĆēcm, a micro-monovision technique can be adopted as reported by Cochener et al. [11].

Regarding the refractive outcome, patients achieved SE within ┬▒ 0.5ŌĆēD in 18 eyes (90%) and within ┬▒ 1.0ŌĆēD in all eyes. To the authorsŌĆÖ best knowledge, no report has been conducted on the distribution of SE; therefore, our results could not be compared with previous studies. Instead, the mean SE value of all previous reports was within ┬▒ 0.5ŌĆēD [10, 11, 19]. This excellent refraction predictability is believed to have contributed to good distance visual acuity. One of the important findings revealed in this study is that the SE measured by AR was significantly more myopic than the SE measured by MR, with a mean difference of ŌłÆ0.53ŌĆēD. Munoz et al. reported that AR showed poor correlation for spherical values with a trend toward more negative values in refractive multifocal IOL [24]. Bissen-Miyajima et al. reported a good correlation between AR and MR in a full aperture diffractive TECNIS┬« bifocal IOL with pupil independency [25]. However, TECNIS┬« Symfony IOL in a pupil-dependent posterior diffractive design has a dominant peak at the intermediate point, and a pupil of <2ŌĆēmm produces continuous peak from far to intermediate focus, which may result in a difference between AR and MR [26, 27].

To achieve optimal performance of multifocal IOL, accurate IOL power calculation is essential. To the authorsŌĆÖ knowledge, no previous report has investigated a formula that fit best in TECNIS┬« Symfony IOL, and Cochener et al. and Pedrotti et al. only used the SRK/T formula [10, 11, 18]. Reitblat et al. reported high accuracy of 86.3 to 93.2% within ┬▒ 0.5ŌĆēD and 100% within ┬▒1.0ŌĆēD without any significant difference between all formulas after implanting AcrySof┬« IQ ReSTOR┬« IOL (Alcon Laboratories, Inc., Fort Worth, TX, USA) [28]. SRK/T, Holladay 2, Haigis, Hoffer Q, Barrett Universal II, and Hill-RBF formulas used in this study also showed high accuracy of 65 to 85% within ┬▒ 0.5ŌĆēD and 95 to 100% within ┬▒1.0ŌĆēD. Based on our results, the Barrett Universal II formula showed an MNE that is closest to 0ŌĆēD and the tendency towards lowest MAE; therefore, the Barrett Universal II formula could be considered as a first reference.

Most previous studies using multifocal IOL have been performed bilaterally, and reports on unilateral surgery are limited [7, 12]. According to previous reports, unilateral multifocal IOL implantation could achieve high spectacle independence and stereoacuity, but significantly less than that after the bilateral surgery [29, 30]. Unlike the previous studies, the patient satisfaction score was as high as 9.06 for far, 8.94 for intermediate, and 6.65 for near vision, even though the ratio of unilateral surgery patients was 82.4%, showing no significant difference in patient satisfaction score or spectacle dependence between binocular and monocular surgery patients. In addition, 92.8% of patients did not complain of binocular disparity in patients who underwent the unilateral surgery. Therefore, EDOF IOL can be effectively used in patients who have presbyopia and unilateral cataract and require good intermediate vision for computer or navigator use.

5. Conclusions

In conclusion, TECNIS┬« Symfony IOL restores excellent visual acuity especially at far and intermediate distances. High accuracy can be achieved by using third- and fourth-generation IOL formulas and evaluating postoperative refractions by MR. The satisfaction levels were high in both unilateral and bilateral patients with low spectacle dependence and no binocular disparity in unilateral surgery patients. Therefore, TECNIS┬« Symfony IOL can be effectively used in not only bilateral cataract patients but also in unilateral patients with presbyopia.

Data Availability

The data used to support the findings of this study are available from the corresponding author upon request.

Conflicts of Interest

The authors declare that there are no conflicts of interest.

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Copyright © 2019 Se Hyun Choi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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