Journal of Refractive Surgery

Original Article Supplemental Data

Visual Outcomes and Subjective Experience After Combined Implantation of Extended Depth of Focus and Trifocal IOLs

Richard N. McNeely, PhD; Salissou Moutari, PhD; Christoph Palme, MD; Jonathan E. Moore, PhD

Abstract

PURPOSE:

To evaluate postoperative visual performance and patient-reported outcomes following combined implantation of an extended depth of focus (EDOF) intraocular lens (IOL) and a trifocal IOL.

METHODS:

The study enrolled consecutive patients undergoing refractive lens extraction or cataract surgery with combined implantation of an EDOF IOL (dominant eye) and a trifocal IOL in the nondominant eye. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, uncorrected intermediate (UIVA) and near (UNVA) visual acuities, defocus curves, and subjective questionnaires were evaluated 1 month postoperatively.

RESULTS:

The study enrolled 100 consecutive patients (200 eyes). The postoperative mean binocular UDVA, UIVA, and UNVA were −0.08 ± 0.07, 0.13 ± 0.12, and 0.17 ± 0.11 logMAR, respectively. The percentage of eyes within ±0.50 and ±1.00 diopters of the refractive target was 65% and 96% with EDOF IOLs, and 76% and 99% with trifocal IOLs, respectively. Of all patients, 91% were satisfied or more than satisfied with the procedure, and 87% of patients were spectacle free for near vision. On a scale from 0 (not at all) to 3 (very), mean scores of 0.52 ± 0.83, 0.71 ± 0.83, and 0.34 ± 0.73 were reported for glare, halos, and starbursts. The mean daytime and nighttime Quality of Vision scores were 9.13 ± 0.91 and 7.96 ± 1.57, respectively.

CONCLUSIONS:

The combination of an EDOF IOL and a trifocal IOL provides good unaided visual acuity for distance and near. This IOL combination provides high postoperative satisfaction and functional vision, but some early visual side effects were reported.

[J Refract Surg. 2020;36(5):326–333.]

Abstract

PURPOSE:

To evaluate postoperative visual performance and patient-reported outcomes following combined implantation of an extended depth of focus (EDOF) intraocular lens (IOL) and a trifocal IOL.

METHODS:

The study enrolled consecutive patients undergoing refractive lens extraction or cataract surgery with combined implantation of an EDOF IOL (dominant eye) and a trifocal IOL in the nondominant eye. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, uncorrected intermediate (UIVA) and near (UNVA) visual acuities, defocus curves, and subjective questionnaires were evaluated 1 month postoperatively.

RESULTS:

The study enrolled 100 consecutive patients (200 eyes). The postoperative mean binocular UDVA, UIVA, and UNVA were −0.08 ± 0.07, 0.13 ± 0.12, and 0.17 ± 0.11 logMAR, respectively. The percentage of eyes within ±0.50 and ±1.00 diopters of the refractive target was 65% and 96% with EDOF IOLs, and 76% and 99% with trifocal IOLs, respectively. Of all patients, 91% were satisfied or more than satisfied with the procedure, and 87% of patients were spectacle free for near vision. On a scale from 0 (not at all) to 3 (very), mean scores of 0.52 ± 0.83, 0.71 ± 0.83, and 0.34 ± 0.73 were reported for glare, halos, and starbursts. The mean daytime and nighttime Quality of Vision scores were 9.13 ± 0.91 and 7.96 ± 1.57, respectively.

CONCLUSIONS:

The combination of an EDOF IOL and a trifocal IOL provides good unaided visual acuity for distance and near. This IOL combination provides high postoperative satisfaction and functional vision, but some early visual side effects were reported.

[J Refract Surg. 2020;36(5):326–333.]

In modern lens-based surgery, it is becoming increasingly important to provide patients with a range of clear vision with the least amount of visual side effects. There are various methodologies currently used, including rotationally asymmetric intraocular lenses (IOLs),1–3 rotationally symmetric IOLs,4,5 trifocal IOLs,6 and monofocal IOLs using a monovision approach.7 These methodologies have been widely accepted and provide patients with spectacle independence, but there are some disadvantages to these treatments, such as unwanted visual phenomena.

Intermediate vision is becoming increasingly important, which has led to the introduction of extended depth of focus (EDOF) IOLs. There is no second out-of-focus image with this IOL design,8 as found with multifocal IOLs, and therefore fewer unwanted visual disturbances have been reported.9,10 The latest EDOF IOL to be introduced is the AT LARA IOL (Carl Zeiss Meditec AG). An early study11 of this EDOF IOL reported the clinical and patient-reported outcomes 1 and 3 months postoperatively. The study reported reasonable unaided distance and near vision with minimal visual phenomena, and high spectacle independence and patient satisfaction.

We previously found that a lower powered near addition (+2.00 diopters [D]) in the dominant eye in combination with a higher powered addition (+3.00 D) in the non-dominant eye provides comparable binocular intermediate and near vision compared to bilateral implantation of a high power addition (+3.00 D) IOL and significantly better overall quality of vision.12

Therefore, we implanted this newly developed EDOF IOL in the dominant eye in combination with a trifocal IOL in the non-dominant eye. It was hoped that this would allow clear distance vision, provide good intermediate vision, and improve near vision in the dominant eye while producing minimal visual phenomena, due to the absence of an out of focus image produced by an EDOF IOL in the dominant eye. Implantation of a trifocal IOL in the non-dominant eye would then provide the necessary power for near vision.

The purpose of this study was to present the clinical outcomes and patient-reported outcomes of this IOL combination, and attempt to compare the outcomes to those reported in a recent study11 of bilateral EDOF IOL implantation.

Patients and Methods

This retrospective study identified patients who underwent refractive lens exchange or cataract surgery with implantation of an EDOF IOL in the dominant eye and a trifocal IOL in the non-dominant eye between March 2018 and March 2019.

All patients gave their informed consent to undergo refractive lens exchange or cataract surgery prior to surgery. This study used only consecutive retrospective unidentifiable patient data and all patients gave their informed consent for their anonymized data to be submitted for audit and publication.

Inclusion criteria for this study were the absence of any other ocular pathology, preoperative corneal astigmatism of 1.50 D or less, and no previous refractive surgery. Exclusion criteria were a history of glaucoma or retinal detachment, ocular inflammation, corneal surgery or disease, neuroophthalmic disease, and macular disease.

Full ophthalmologic assessment was performed on all patients preoperatively. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities were evaluated with logarithmic acuity (logMAR) charts, and uncorrected intermediate (UIVA) and near (UNVA) visual acuities were evaluated with Radner reading charts (70 and 40 cm). Slit-lamp examination, Goldmann tonometry, and dilated funduscopy were completed. Stereopsis (TNO stereo test), corneal topography (OPD-Scan II; NIDEK Co., Ltd.), corneal tomography (Pentacam; Oculus Optikgeräte GmbH), and retinal optical coherence tomography (Cirrus 4000 OCT; Carl Zeiss Meditec AG) were also completed. Biometry was completed with the Aladdin device (Topcon Europe Medical). The Hoffer Q formula was used when the axial length was 22 mm or less, and the SRK/T or Haigis formulas were used when the axial length was 22 mm or more. Surgeon-optimized A-constants were used for all three formulas. Ocular dominance was assessed using the pointing methodology, where patients point at a spot light source 6 m in the distance, ensuring their finger and the light source are visually aligned. Then each eye is occluded and the eye where the separation between the finger and the light source is smallest is considered to be the dominant eye. Patients were also asked to report which eye they would use for sighting a camera and a rifle. Consistency between the tests confirmed the dominant eye.

Patients were examined 1 month postoperatively. This examination included manifest refraction, UDVA, CDVA, UIVA, and UNVA, and any adverse event was recorded. Patients also completed a purpose-developed quality of vision questionnaire (Table A, available in the online version of this article), which was to be complementary to that used in the study reporting bilateral EDOF IOL outcomes.11 Patients reported their responses on a Likert scale, and pictures were used in conjunction with the questions to aid understanding. In addition, a linear 0 to 10 scale was used to define each patient's subjective view of total quality of vision to gain a better understanding of his or her postoperative satisfaction. Furthermore, patient experience was assessed through a purpose-developed satisfaction questionnaire regarding their distance, intermediate, and near vision, and their overall satisfaction (Table B, available in the online version of this article).

Quality of Vision Questionnaire

Table A:

Quality of Vision Questionnaire

Patient Experience Questionnaire

Table B:

Patient Experience Questionnaire

IOLs

The AT LARA 829MP IOL (Carl Zeiss Meditec AG) is based on a diffractive principle with an aspheric design and is made from hydrophilic acrylic with hydrophobic surface properties. This IOL has a chromatic aberration-correcting and aberration-neutral optical design. Furthermore, the IOL has a light bridge optical design where it uses two additions of +0.95 and +1.90 D. The Smooth Microphase technology minimizes light scattering and thus visual phenomena. It has a 6-mm optic size and an 11-mm overall length. The available powers are −10.00 to +32.00 D in 0.50-D increments.

The AT LISA tri 839MP IOL (Carl Zeiss Meditec AG) is a diffractive trifocal IOL made from hydrophilic acrylic with hydrophobic surface properties. It has a 6-mm optic size and an 11-mm overall length. It is available in powers between 0.00 and +32.00 D in 0.50-D increments. The near addition powers of this IOL are +1.66 D for intermediate vision and +3.00 D for near vision.

Surgical Technique

All surgeries were performed by the same experienced surgeon (JEM). The surgery was performed under sub-Tenon or topical anesthesia. The foldable IOL was inserted through an incision of 2.75 mm after phacoemulsification. All patients had the steepest axis marked while they were in an upright position and all incisions were placed on this steepest meridian. The multifocal IOL was implanted into the capsular bag. The dominant eye was operated on first and the non-dominant eye was operated on 1 week later; the refractive aim was emmetropia in all cases.

Statistical Analysis

Statistical analysis was performed using SPSS for Windows (Statistical Package for the Social Sciences, version 25; SPSS, Inc.) and Excel (Microsoft Corporation) software. Means and standard deviations or percentages were used to report the preoperative and postoperative parameters. The Kolmogorov–Smirnov test was used to assess normality. The Student's paired t test was used to compare preoperative and postoperative data when assessing continuous normal data, and the independent t test was used to compare continuous normal data between IOLs. The Wilcoxon ranked-sum test was applied when assessing nonparametric data. For all statistical analysis, the level of significance was a P value of less than .05.

Results

This study included 200 eyes of 100 patients with a mean age of 58.2 ± 6.9 years (range: 43 to 80 years). Table 1 outlines the demographics and the preoperative clinical data.

Demographics and Clinical Data

Table 1:

Demographics and Clinical Data

Visual Acuity

Figure 1 outlines the postoperative UDVA and CDVA for both IOLs. All EDOF IOL eyes achieved a postoperative UDVA of 20/32 or better, and 86% of eyes achieved 20/20 or better. All eyes had a postoperative CDVA of 20/25 or better. Similarly, all eyes achieved postoperative UDVA of 20/32 or better with the trifocal IOLs, and 88% achieved 20/20 or better. Ninety-eight percent of patients achieved a binocular UDVA of 20/20 or better. Likewise, 100% of eyes achieved a CDVA of 20/25. Figure 2 shows that 68% of eyes with both IOL designs had the same postoperative UDVA and CDVA. Table 2 outlines the mean logMAR values for UDVA, CDVA, UIVA, and UNVA. The mean binocular UIVA was 0.13 ± 0.12 logMAR and the mean binocular UNVA was 0.17 ± 0.11 logMAR, with 97% of patients achieving binocular UNVA of 0.4 logMAR or better. There was a significant difference between the two IOL designs in both UIVA and UNVA (Table 2). Figure 3 shows the mean binocular defocus curve for both the combination IOL implantation in this study and 5 patients who received bilateral AT LARA IOL implantation with an emmetropic outcome in each eye (data not presented).

Cumulative binocular uncorrected (UDVA) vs corrected (CDVA) visual acuity for the (A) extended depth of focus and (B) trifocal intraocular lens postoperatively.

Figure 1.

Cumulative binocular uncorrected (UDVA) vs corrected (CDVA) visual acuity for the (A) extended depth of focus and (B) trifocal intraocular lens postoperatively.

Histogram showing the efficacy of lines of difference between postoperative uncorrected (UDVA) vs corrected (CDVA) visual acuity for both intraocular lens designs. The AT LARA and AT LISA lenses are manufactured by Carl Zeiss Meditec AG.

Figure 2.

Histogram showing the efficacy of lines of difference between postoperative uncorrected (UDVA) vs corrected (CDVA) visual acuity for both intraocular lens designs. The AT LARA and AT LISA lenses are manufactured by Carl Zeiss Meditec AG.

Postoperative Clinical Data (Mean ± SD [Range])

Table 2:

Postoperative Clinical Data (Mean ± SD [Range])

Binocular defocus curves for the study lenses. The AT LARA and AT LISA lenses are manufactured by Carl Zeiss Meditec AG. D = diopters

Figure 3.

Binocular defocus curves for the study lenses. The AT LARA and AT LISA lenses are manufactured by Carl Zeiss Meditec AG. D = diopters

Refractive Predictability

Figure 4 shows the accuracy to the intended target of both IOL designs. Postoperatively, 65% of EDOF IOLs eyes and 76% of the trifocal IOL eyes were within ±0.50 D of the refractive target, and 96% of the EDOF IOL eyes and 99% of trifocal IOL eyes were within ±1.00 D. Figure 5 outlines the postoperative refractive cylinder, where 88% and 79% of eyes had 0.50 D or less with both respective IOL designs.

Accuracy to the intended spherical equivalent refraction postoperatively for both intraocular lens designs. The AT LARA and AT LISA lenses are manufactured by Carl Zeiss Meditec AG. D = diopters

Figure 4.

Accuracy to the intended spherical equivalent refraction postoperatively for both intraocular lens designs. The AT LARA and AT LISA lenses are manufactured by Carl Zeiss Meditec AG. D = diopters

Postoperative refractive cylinder for both intraocular designs. The AT LARA and AT LISA lenses are manufactured by Carl Zeiss Meditec AG. D = diopters

Figure 5.

Postoperative refractive cylinder for both intraocular designs. The AT LARA and AT LISA lenses are manufactured by Carl Zeiss Meditec AG. D = diopters

Table 1 outlines the difference in sphere, cylinder, and mean spherical equivalent between the two IOL designs. Furthermore, there was no statistically significant difference in the mean accuracy to the attempted postoperative refractive target between the two IOL designs, with the EDOF IOL showing a mean difference of 0.23 ± 1.30 and the trifocal IOL a mean difference of 0.10 ± 1.25 (P = .475, independent t test).

Patient-Reported Outcomes

Table B outlines the responses from a patient satisfaction questionnaire, where 95% of patients reported better postoperative vision, 97% patients would choose the procedure again, and 97% would recommend the procedure. Eighty-eight percent of patients reported never requiring reading glasses postoperatively, with 11% reporting only occasional use. Ninety-one percent of patients reported being more than fulfilled or fulfilled with the procedure. For distance vision tasks, 98% of patients reported clear distance vision or only a slight problem with distance vision, 96% reported clear intermediate vision or only a slight problem, and 95% reported clear near vision or only a slight problem with near vision. Only 2% of patients reported a severe problem with distance vision and 1% with near vision.

There was a statistically significant increase in postoperative starbursts, but patients reported a significantly improved overall quality of vision score out of 10 for both night and day (Table 3).

Postoperative Visual Phenomena (Mean ± SD, Range)a

Table 3:

Postoperative Visual Phenomena (Mean ± SD, Range)

Discussion

Multifocal IOLs provide high patient satisfaction and spectacle independence, but they can produce visual phenomena that can lead to postoperative dissatisfaction.13,14 Furthermore, photic phenomena have been found to be a leading cause of explantation of multifocal IOLs.15 EDOF IOLs have since been introduced in an attempt to produce a visual quality similar to monofocal IOLs, provide an extended range of vision from distance to near,10 and create fewer unwanted visual phenomena.16 However, it is well reported that bilateral implantation of EDOF IOLs provide inferior binocular UNVA outcomes than other multifocal IOL designs.5,17,18

Our previous study12 outlined the benefits of using a lower addition rotationally asymmetric multifocal IOL in the dominant eye with a higher powered addition in the nondominant eye, and showed that binocular UDVA, UIVA, and, importantly, UNVA were similar to that provided by bilateral implantation of high addition asymmetric multifocal IOLs, with patients reporting a higher level of quality of vision with a lower addition rotationally asymmetric multifocal IOL in the dominant eye. Therefore, the aim of the implantation methodology used in this study was to provide a clear range of vision and reduce visual phenomena. The EDOF IOL was used to provide clear distance vision with minimal visual phenomena, and also good intermediate vision and some near vision in the dominant eye. This was combined with a high quality trifocal IOL in the non-dominant eye. The trifocal IOL used has been found to provide good visual outcomes, high patient satisfaction, and spectacle independence.19 This trifocal IOL was implanted in the non-dominant eye to provide the required near power for good close visual function that may not be provided by the EDOF IOL. The EDOF IOL was implanted first to provide immediate postoperative subjective satisfaction.

In the current study, this combination displayed good UDVA. Both the EDOF and trifocal IOLs showed excellent monocular UDVA with no significant difference between the two IOL designs (Table 2).

A superior distance visual acuity was found compared to an extensive study of rotationally asymmetric multifocal IOLs,1 which reported that 80.5% of patients achieved 0 logMAR or better compared to 99% in the current study. Furthermore, a study outlining the outcomes of bilateral implantation of a trifocal IOL reported a binocular UDVA of 0.00 ± 0.094 logMAR compared to −0.08 ± 0.07 logMAR in the current study.20 The mean postoperative binocular UIVA is similar to that found in a study that outlines the outcomes following bilateral implantation of a trifocal IOL where the binocular UIVA was 0.12 ± 0.143 logMAR,21 and superior to that in a study of bilateral rotationally asymmetric multifocal IOLs, where the mean postoperative binocular UIVA was 0.21 ± 0.13 logMAR.22 Furthermore, the binocular UNVA is comparable to that found in other studies of trifocal IOLs23 where a mean UNVA of 0.22 ± 0.13 was reported, and bifocal IOLs with a UNVA of 0.12 ± 0.13 at 3 months,24 compared to 0.17 ± 0.11 logMAR in the current study. This study displayed better binocular UNVA compared to a mean binocular UNVA of 0.26 ± 0.14 logMAR reported in the study of bilateral implantation of the latest EDOF IOLs.11 This is what one would expect with this combination including a trifocal IOL.

One limitation of the current study is that it does not directly compare this combination to other bilateral implantations of other multifocal or EDOF IOLs. However, this study appears to highlight a range of clear unaided visual acuity that is comparable to other studies of presbyopia-correcting IOL designs. It therefore appears this combination of IOLs provides good objective visual outcomes for patients with cataract and refractive lens exchange. Defocus curve assessment highlighted peak visual acuity in the distance with a gradual decrease in visual acuity to a viewing distance of 50 cm. There is a stable level of visual acuity at 0.10 logMAR between 50 and 33 cm. This study attempted to compare the combination implantation to bilateral implantation of the EDOF IOL, and the defocus curve for the bilateral EDOF IOLs (data not presented) displayed peak visual acuity at distance and again at 1 m, then decreased from the 1 m viewing distance. Visual acuity is superior at near viewing distances with the combination of EDOF and trifocal IOLs (Figure 3).

The IOL combination displayed a high level of accuracy to the intended spherical equivalent, as outlined in Figure 4. Further optimization of surgeon A-constants may improve these results. The EDOF IOL shows a slight hyperopic tendency in the early postoperative period with 58% of eyes within 0.14 to 1.00 D of the refractive target compared to 6% within −0.14 to −1.00 D. Similar findings were found for the trifocal IOL, with 60% within 0.14 to 1.00 D compared to 13% within the same myopic parameters. As previously acknowledged, this may be due to the IOL moving posteriorly due to capsular contractions and early keratometric changes,25,26 and subsequent adjustments have been made to A-constants to address this. In the current study, 5 eyes had a postoperative refractive cylinder of greater than 1.00 D. The postoperative refractive cylinder was statistically significantly less compared to preoperative values for the EDOF IOL (P < .001, paired t test) and the trifocal IOL (P = .001, paired t test). A recent study11 following bilateral EDOF IOL implantation showed a mean postoperative refractive cylinder greater than in our study and the range was found to be 0.00 to 2.50 D at 1 month and 0.00 to 2.75 D at 3 months.

This study also sought to assess patient satisfaction and functional vision through postoperative questionnaires. Ninety-eight percent of patients reported clear or only a slight problem with distance vision, with two patients reporting a severe problem. One of these patients reported being “very” annoyed by glare, halos, and starbursts at this early postoperative period, particularly with driving, which the patient did 2 to 4 hours each day. This patient reported that distance vision was clear for watching television. This highlights that the patient's lifestyle was affecting satisfaction with distance vision. The second patient also reported being “very” annoyed by glare and “quite” annoyed by halos. Likewise, this patient drove 2 to 4 hours per day, which clearly affected the subjective response to this question. One would expect these symptoms to improve when neuroadaptation occurs and these patients will be closely monitored.

When questioned about required reading glasses, 99% of patients reported never or only occasionally requiring reading glasses. When asked specifically regarding the difficulty with near vision tasks, 79% reported that their near vision was clear and 16% reported experiencing only a slight problem with their near vision. One patient reported having a severe problem with near vision; the patient had +0.75 D spherical equivalent in the dominant eye and +0.25 D spherical equivalent in the non-dominant eye. This patient reported requiring reading glasses for fine details and still reported being “fulfilled” with the procedure at this early postoperative stage.

Additionally, 91% of patients reported being more than fulfilled or fulfilled regarding how their expectations were fulfilled with the procedure. Different questions were used in the bilateral EDOF IOL study,11 but it appears that a similar overall satisfaction rating was reported compared to this study, with 89.2% of patients reporting to be either very satisfied or satisfied with their vision. Interestingly, 97.1% of patients with bilateral EDOF IOL implantation reported never using any correction or up to 25% of the time for close work, despite clearly reduced binocular UDVA compared to the outcomes in this current study. Use of the same questions and Likert scale would allow better comparison between the two implantation methodologies.

A high level of overall quality of vision for this combination of IOLs was observed. Both the day and night overall quality of vision scores significantly improved when compared to preoperative responses, and compared favorably to other similar studies.24,27 Comparison between preoperative and postoperative outcomes appeared to show better adaptation compared to bilateral EDOF IOLs, where a statistically significant increase in postoperative glare, halos, and starbursts was reported.11 However, further analysis of this combination of IOLs is required in a study with longer postoperative follow-up to determine how neuroadaptation affects subjective outcomes and the incidence of posterior subcapsular opacities. Furthermore, direct comparison to bilateral EDOF IOL implantation would allow a more accurate assessment. It is clear from this study that a combined implantation of an EDOF IOL and a trifocal IOL does not cause a significant increase in unwanted visual phenomena and provides high overall quality of vision scores.

Preoperatively, all patients were assessed for stereopsis, and stereopsis must be present prior to implantation of this IOL combination to maximize function. If stereopsis is absent, visual outcomes will depend predominately on the defocus curve of the dominant eye.

This study found that the combined implantation of an EDOF IOL in the dominant eye and a trifocal IOL in the non-dominant eye provides excellent overall quality of vision and a range of clear vision. The EDOF IOL appears to provide high quality of vision, with the trifocal IOL also providing a range of clear vision but importantly providing enough near addition to allow clear near vision binocularly and therefore spectacle independence.

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  27. McNeely RN, Pazo E, Spence A, et al. Visual quality and performance comparison between 2 refractive rotationally asymmetric multifocal intraocular lenses. J Cataract Refract Surg. 2017;43(8):1020–1026. doi:10.1016/j.jcrs.2017.05.039 [CrossRef]

Demographics and Clinical Data

ParameterAT LARA (EDOF IOL)AT LISA (Trifocal IOL)
Preoperative
  No. of patients (eyes)100 (100)100 (100)
  Age (y), mean ± SD (range)58.2 ± 6.9 (43 to 80)
  Gender, male/female (%)37/63
  Myopia/hyperopia (%)24/76
  Axial length (mm), mean ± SD (range)23.57 ± 1.12 (21.47 to 27.27)23.59 ± 1.20 (20.98 to 27.85)
  Power of implanted IOL (D), mean ± SD (range)20.85 ± 3.22 (9.5 to 27.5)21.62 ± 3.73 (7 to 29)
Clinical, mean ± SD (range)
  Sphere (D)1.08 ± 2.43 (−10.00 to 5.00)1.13 ± 2.65 (−12.00 to 5.25)
  Cylinder (D)−0.48 ± 0.40 (−2.00 to 0.00)−0.50 ± 0.46 (−2.25 to 0.00)
  MSE (D)0.84 ± 2.63 (−11.00 to 5.00)0.88 ± 2.88 (−13.13 to 5.25)
  CDVA (logMAR)−0.02 ± 0.23 (−0.20 to 1.85)−0.03 ± 0.17 (−0.20 to 1.20)

Postoperative Clinical Data (Mean ± SD [Range])

ParameterAT LARA (EDOF IOL)AT LISA (Trifocal IOL)P
No. (%)50 (100)50 (100)
Sphere (D)0.42 ± 0.42 (−0.50 to 1.75)0.31 ± 0.41 (−0.50 to 1.50).070
Cylinder (D)−0.27 ± 0.32 (−1.50 to 0.00)−0.31 ± 0.35 (−1.50 to 0.00).371
MSE (D)0.29 ± 0.38 (−0.50 to 1.50)0.16 ± 0.35 (−0.88 to 1.13).014
UDVA (logMAR)−0.01 ± 0.09 (−0.20 to 0.22)−0.02 ± 0.09 (−0.20 to 0.24).858
Binocular UDVA (logMAR)−0.08 ± 0.07 (−0.20 to 0.12)
UIVA (logMAR)0.17 ± 0.13 (−0.10 to 0.70)0.21 ± 0.13 (−0.10 to 0.70).014
Binocular UIVA (logMAR)0.13 ± 0.12 (−0.10 to 0.70)
UNVA (logMAR)0.34 ± 0.15 (0.00 to 0.80)0.19 ± 0.13 (0.00 to 0.70)< .001
Binocular UNVA (logMAR)0.17 ± 0.11 (0.00 to 0.50)
CDVA (logMAR)−0.08 ± 0.06 (−0.20 to 0.14)−0.07 ± 0.06 (−0.20 to 0.10).856

Postoperative Visual Phenomena (Mean ± SD, Range)a

ParameterPreoperativePosotoperativeP
Glare0.62 ± 0.84 (0 to 3)0.52 ± 0.83 (0 to 3).366
Halos0.34 ± 0.62 (0 to 2)0.71 ± 0.83 (0 to 3).001
Starburst0.42 ± 0.68 (0 to 3)0.34 ± 0.73 (0 to 3).476
Hazy vision0.21 ± 0.61 (0 to 3)0.09 ± 0.35 (0 to 2).090
Blurred vision0.23 ± 0.66 (0 to 3)0.21 ± 0.54 (0 to 2).753
Distortion0.03 ± 0.22 (0 to 2)0.05 ± 0.30 (0 to 2).581
Double vision0.02 ± 0.20 (0 to 2)0.03 ± 0.22 (0 to 2).785
Vision fluctuation0.24 ± 0.51 (0 to 2)0.22 ± 0.51 (0 to 2).727
Depth perception0.09 ± 0.32 (0 to 2)0.07 ± 0.29 (0 to 2).627
Quality of vision dayb8.16 ± 1.60 (2 to 10)9.16 ± 0.88 (7 to 10)<.001
Quality of vision nightb7.38 ± 1.93 (3 to 10)7.93 ± 1.56 (2 to 10).002

Quality of Vision Questionnaire

Do you experience glare, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Do you experience halos, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Do you experience starbursts, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Do you experience hazy vision, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Do you experience blurred vision, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Do you experience distortion, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Do you experience double vision, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Do you experience a fluctuation in vision, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Do you experience a difficulty in depth perception, and how much does it bother you?
0 = Not at all1 = A little2 = Quite3 = Very

Patient Experience Questionnaire

Compare your vision preoperative to postoperative
Better = 95%Unchanged = 4%Worse = 1%Can't remember = 0%

Would you choose this procedure again?
Yes = 97%No = 1%Maybe = 2%

Would you recommend this procedure?
Yes = 97%No = 1%Maybe = 2%

How often do you require reading glasses?
Never = 88%Occasionally = 11%Quite often = 1%Always = 0%

How much difficulty do you have doing a regular task that requires you to see well in the distance?
Distance vision is clear = 92%Slight problem = 6%Moderate problem = 0%Severe problem = 2%Intolerable problem = 0%

How much difficulty do you have doing a regular task that requires you to see well at intermediate working distances?
Intermediate vision is clear = 87%Slight problem = 9%Moderate problem = 4%Severe problem = 0%Intolerable problem = 0%

How much difficulty do you have doing a regular task that requires you to see well at near working distances?
Near vision is clear = 79%Slight problem = 16%Moderate problem = 4%Severe problem = 1%Intolerable problem = 0%

How were your expectations fulfilled with the procedure?
More than fulfilled = 43%Fulfilled = 48%Sufficiently fulfilled = 8%Not fulfilled at all = 1%
Authors

From Cathedral Eye Clinic, Belfast, Northern Ireland, United Kingdom (RNM, CP, JEM); School of Mathematics and Physics, Queens University Belfast, Belfast, Northern Ireland, United Kingdom (SM, JEM); Biomedical Sciences Research Institute, University of Ulster, Coleraine, Northern Ireland, United Kingdom (JEM); and Tianjin Medical University, Tianjin, People's Republic of China (JEM).

Dr. Moore is a consultant for Carl Zeiss Meditec. The remaining authors have no financial or proprietary interest in the materials presented herein.

AUTHOR CONTRIBUTIONS

Study concept and design (RNM, SM, CP, JEM); data collection (RNM, JEM); analysis and interpretation of data (RNM, JEM); writing the manuscript (RNM, JEM); critical revision of the manuscript (SM, CP, JEM); statistical expertise (JEM); supervision (JEM)

Correspondence: Jonathan E. Moore, PhD, Cathedral Eye Clinic, 89-91 Academy Street, Belfast, County Antrim, BT1 2 LS, Northern Ireland, United Kingdom. Email: jmoorecathedral@gmail.com

Received: December 20, 2019
Accepted: March 18, 2020

10.3928/1081597X-20200318-01

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