Introduction
Although monocular intraocular lenses (IOLs) have improved the visual quality of patients undergoing cataract surgery, the independence of correction for intermediate and near vision is increasing. In the last decade, several types of multifocal IOLs have been designed to improve spectacle independence after cataract surgery. Unlike the preceding monofocal IOLs, multifocal IOLs provide good visual outcomes at different distances [
1]. Moreover, new generation multifocal IOLs have been designed to overcome some disadvantages of previous multifocal IOLs attributable to their inherent optical design, such as the perception of photic phenomena, reduced contrast sensitivity (CS), and decreased visual function in dim light environments [
2,
3]. For a successful outcome and meet patients' expectation, it is crucial to consider preoperative factors, including biometric measurements, pupil reactivity or patient’s lifestyle [
1].
Tecnis® Symfony® ZXR00 (Abbott Laboratories, Illinois, USA) produces an extended depth of focus in order to improve visual outcomes at intermediate distances. Previous studies have revealed that Tecnis Symfony IOLs exhibit good visual outcomes after surgery [
4,
5]. In particular, they provide better objective and subjective quality of vision and CS compared to trifocal lenses and produce less photopic phenomena [
5‐
7]. Nevertheless, their performance is worse at near vision, and acceptable intermediate vision varies largely among patients. Therefore, the aim of this study was to analyze demographic and preoperative factors related to enlarged postoperative depth-of-focus in patients implanted with Tecnis Symfony ZXR00.
Methods
Study design and participants
This prospective study included 131 eyes of 66 patients with bilateral cataracts that underwent phacoemulsification cataract surgery and Tecnis Symfony IOL implantation. Patients were recruited at the ophthalmology department of Nuestra Señora de Gracia Hospital in Zaragoza, and prospectively evaluated at 1-month, 3-months, and 6-months. Patients were selected according to the guidelines of the general protocol of cataract surgery dictated for our hospital. Inclusion criteria were no alterations or previous ophthalmological surgeries, no dry eye, topographic astigmatisms lower than 1.00 D (total astigmatism, including posterior surface), postoperative corrected visual acuity (CDVA) better than 0.2 logMAR, no intra- or postoperative complications, absence of posterior capsule opacification (PCO) during the study, and a center shift value (distance between corneal apex and center of pupil) lower than 1 mm. The study protocol was approved by the local ethics committee CEICA (Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón) and patients gave written informed consent following the tenets of Declaration of Helsinki.
Intraocular lens
Tecnis® Symfony® ZXR00 lens is a single-piece, biconvex, hydrophobic acrylic folding lens, with a posterior diffractive surface and an anterior aspherical surface that adds a −0.27 μm spherical aberration to compensate the positive corneal spherical aberration. It also uses a proprietary achromatic diffractive Echelette design that corrects the corneal chromatic aberration for enhanced CS [
4]. Its overall diameter is 13.0 mm, and its optical zone diameter is 6.0 mm. The power spectrum available ranges from + 5.0 to + 34.0 D and incorporates an ultraviolet (UV) light-absorbing filter.
Surgical procedure
Surgery was performed under topical anesthesia by the same experienced surgeon (J.M.L.) and using the same standard phacoemulsification technique. A 2.7 mm clear incision was made at temporal site (180º-0º) using a blade. The capsulotomy size intended by the surgeon was 5.5 mm and the resulting size of capsulotomy next day to the surgery was approximately 5.25 mm. SRK-T, Kane and Barret Universal II formulas were used to calculate the power of the IOL. The target refractive outcome was emmetropia. The selected IOL constant was 119.36. The second eye was intervened 1 month after the first one.
Study evaluations
All patients underwent a complete preoperative examination that included: exploration of the anterior segment with slit lamp, Goldmann applanation tonometry and posterior pole fundoscopy after pharmacological mydriasis. Optical biometry was performed using IOLMaster 500 (Carl Zeiss Meditec AG, Jena, Germany). AL, anterior chamber depth (ACD), mean keratometry, astigmatism (A) and spherical equivalent (SE) were obtained. Corneal keratometry (K) and aberrations were measured using the Pentacam Scheimpflug camera (OculusWetzlar, Germany). In addition, pupillary size and corneal aberrations were measured using the KR-1 W wavefront analyzer (Topcon Medical Laser Systems, Inc., CA, USA) preoperatively and one month after the implantation of both IOLs.
One-month after the surgery of the second eye, monocular and binocular CDVA and uncorrected distance visual acuities (UDVA) were measured under photopic light conditions (85 cd/m2), using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (ESV-3000 ETDRS System, Vectorvision, Inc.) at 4 m. The procedure was repeated for obtaining VA at intermediate (63 cm) and near (40 cm) distances with best distance correction. Distance VA under environmental mesopic light conditions (6 cd/m2), and using a filter on top of the ETDRS chart, was also measured in this visit.
At 3- months, monocular and binocular distance corrected CS under photopic (85 cd/m2) and mesopic (6 cd/m2) light conditions were measured at 2.5 m with CSV-1000E test using sine wave gratings with different spatial frequencies: 3 cpd (cycles per degree of visual angle), 6 cpd, 12 cpd and 18 cpd. Patients that did not see the first stimuli were assigned a 0 value.
Six months after the surgery, the defocus curve was calculated using powered lenses from −5.00 to + 3.00 D, in intervals of 0.50 D. ETDRS charts were randomly changed 3 times during these procedures to avoid memorization. The first one was used to measure DCVA with 0 defocus. Then, the chart was changed to measure VA using lenses from −5 to −0.50 D, in steps of 0.50D. A third ETDRS chart was used for measuring VA from + 3D to + 0.50D. The range of clear vision (RCV) was obtained monocularly as the magnitude of diopters within the defocus curve in which the best corrected visual acuity (BCVA) was equal or greater than 0.1 logMAR. Patients answered the NEI-RQL-42 questionnaire, which measures vision on daily activities (items 2 to 22), perceived patient’s vision (items 13 to 22), optical corrections (items 23 to 35), and related possible problems (36 to 42). The NEI-RQL-42 score ranges from 0 to 100, 100 representing the best quality of life perceived by the patient. Usually, 13 subitems are calculated based on the following categories: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, satisfaction with correction.
Statistical analysis
Statistical analysis was done in R (version 3.6.1) and RStudio (version 1.2.1335). Data distribution was checked for normality using the Shapiro-Wilks test. Analyses were conducted using generalized estimating equation (GEE) models with an exchangeable working correlation structure to account for correlation between the two eyes from a single participant and using geepack package to perform all GEE analyses. p-values lower than 0.05 were considered to be statistically significant.
Discussion
In this study, we investigated demographic and preoperative biometric measurements associated with 6-months postoperative range of clear vision of eyes implanted with Tecnis® Symfony® ZXR00 IOL after phacoemulsification. Our results indicate that young age, male sex, and smaller axial length and pupil size were associated with wider range of clear vision at 6-months. These results indicate that even in highly selected patients for IOL implantation (less than 1D corneal astigmatism, low ocular aberrations, no ocular pathology), there are demographic and biometric factors that could predict postoperative range of clear vision.
Tecnis® Symfony® ZXR00 is an EDoF IOL that presents a wide range of sharp vision with minimal associated photic phenomena. The results of this study reveal that postoperative UDVA and CDVA were favorable, achieving proper intermediate VAs and enlarged amplitude of pseudo-accommodation. In addition, subjective optimal correction and postoperative patient satisfaction were high. The studies published over the last two years are in line with the current findings, highlighting good visual outcomes after Tecnis Symfony implantation [
8‐
12]. However, most authors agree that near vision might be limited in some patients. Even with distance corrected refraction, it has been observed that some patients achieve good visual acuities (≤ 0.1 LogMAR or 0.8 decimal) as near as 20 cm, whereas others only reach a sharp vision until one meter. Some authors have suggested that targeting a mild myopia in non-dominant eye improves postoperative outcomes [
10]. The variability in the range of clear vision with multifocal IOL has been attributed to several factors, but the influence on extended focus IOLs has not been extensively explored. In the current study, we found that younger age was associated with wider range of clear vision, which is in line with studies evaluating apparent accommodation in eyes with a monofocal IOLs [
13]. Moreover, we also found that male gender was associated with wider range of clear vision in the defocus curve measured at 6 months. However, it should be noted that the youngest patients were all male, and this fact might have confounded the current results. On the other hand, spherical aberration is known to increase the depth of focus, although it deteriorates CS [
14]. Furthermore, other preoperative high order aberrations have also been associated with different postoperative vision measurements, mainly in near vision [
15]. However, we only found significant associations between preoperative spherical and high order aberrations and postoperative defocus curve with 6-mm pupil size, and not with 4-mm, which is the effective pupil size in mesopic conditions. This could be because patients were highly selected for the present study and pronounced preoperative aberrations were considered an exclusion criterion, narrowing the variability of aberrations for smaller pupil sizes.
Lastly, preoperative photopic pupil size is critical for multifocal IOL implantation [
16], being larger pupil sizes correlated with better distance visual acuity and with worse near visual acuity [
17,
18]. Still, the relationship with preoperative pupil size and the postoperative range of clear vision has not been explored in EDoF IOLs. According to our results, preoperative pupil size was negatively associated with the range of clear vision, suggesting that patients with larger pupil sizes presented reduced defocus curves. Lastly, ocular biometric measurements change as a function of age and gender [
19‐
23] and both factors were significantly associated with the outcome of interest. Therefore, all GEE models were adjusted for age and sex. These analyses revealed that axial length was also negatively associated with the range of clear vision. Previous studies have reported that both short axial length and small pupil size predict good near vision after monofocal IOL implantation [
23], but their relationship was not explored in EDoF IOLs until now.
This study has several limitations. First, the primary endpoint was the monocular defocus curve measured 6 months after implantation, and no further visual variables were considered, like near and intermediate vision VA or CS or patient satisfaction. However, we believe that the defocus curve is a faithful representation of the dynamic range of clear vision in a single variable. Second, IOL centration was not assessed after IOL implantation, which might have confounded the visual outcomes and the current results. Nevertheless, the EDoF IOLs are more robust against optical quality degradation caused by IOL decentration [
24]. Also, the lack of a control group is a major limitation of the current this study, and future works focusing on the performance of EDoF IOLs in comparison with monofocal and multifocal IOLs are needed. Finally, it is important to highlight that we excluded patients with poorer visual performance, like patients with capsular opacification, visual acuity above 0.2 logMAR… so it should be taken into account that our results do not determine the real clinical performance of EDoF lenses. On the other hand, this work has several strengths. The use of GEE overcomes some of the statistical shortcoming of previous studies, in which the intrasubject inter-eye correlation was controlled by including one eye per patients or not controlling at all for this effect. Moreover, as far as we know, this is the first study revealing the association between preoperative demographic and biometric measurements and postoperative range of clear vision after an EDoF IOL implantation and sets the ground for future studies in the field.
In conclusion, the present study demonstrated that age, sex, preoperative pupil size, and preoperative axial length were associated with an enlarged range of clear vision in eyes implanted with Tecnis Symfony ZXR00 IOL. The performance of Tecnis Symfony is expected to be maximized by smaller pupil sizes and axial lengths, and in young patients. Regardless of these variables, Tecnis Symfony provides excellent visual results at distance and at intermediate distances and in different light conditions if patients are carefully selected.
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