Journal of Refractive Surgery

Original Article Supplemental Data

Initial Clinical Outcomes of a New Extended Depth of Focus Intraocular Lens

Steven C. Schallhorn, MD; David Teenan, MD; Jan A. Venter, MD; Stephen J. Hannan, OD; Julie M. Schallhorn, MD

Abstract

PURPOSE:

To evaluate clinical and patient-reported outcomes of a new extended depth of focus intraocular lens (IOL).

METHODS:

Data of patients treated between September 2017 and September 2018 who underwent a refractive lens exchange/cataract surgery with an implantation of the AT LARA 829MP IOL (Carl Zeiss Meditec AG, Jena, Germany) and attended the 1-week, 1-month, and 3-month follow-up visit were reviewed.

RESULTS:

At 3 months, the percentage of eyes within ±0.50 diopters (D) of emmetropia was 86.7%. The mean binocular uncorrected distance visual acuity was −0.05 ± 0.09 logMAR and the mean binocular unaided near vision was 0.26 ± 0.14 logMAR. Of all patients, 90.3% were satisfied with their vision. The percentage of patients spectacle-free for near and distance vision was 83.6% and 95.4%, respectively. On a scale from 1 (no difficulty) to 7 (severe difficulty), there was an average 1.2 to 1.4 units increase in glare, halo, and starburst between the preoperative and 1-month visit, and a decrease of 0.2 to 0.3 units between the 1- and 3-month visit.

CONCLUSIONS:

The new extended depth of focus IOL provided reasonable unaided near and distance vision, as well as spectacle independence and patient satisfaction. Some optical side effects were reported in the early postoperative period.

[J Refract Surg. 2019;35(7):426–433.]

Abstract

PURPOSE:

To evaluate clinical and patient-reported outcomes of a new extended depth of focus intraocular lens (IOL).

METHODS:

Data of patients treated between September 2017 and September 2018 who underwent a refractive lens exchange/cataract surgery with an implantation of the AT LARA 829MP IOL (Carl Zeiss Meditec AG, Jena, Germany) and attended the 1-week, 1-month, and 3-month follow-up visit were reviewed.

RESULTS:

At 3 months, the percentage of eyes within ±0.50 diopters (D) of emmetropia was 86.7%. The mean binocular uncorrected distance visual acuity was −0.05 ± 0.09 logMAR and the mean binocular unaided near vision was 0.26 ± 0.14 logMAR. Of all patients, 90.3% were satisfied with their vision. The percentage of patients spectacle-free for near and distance vision was 83.6% and 95.4%, respectively. On a scale from 1 (no difficulty) to 7 (severe difficulty), there was an average 1.2 to 1.4 units increase in glare, halo, and starburst between the preoperative and 1-month visit, and a decrease of 0.2 to 0.3 units between the 1- and 3-month visit.

CONCLUSIONS:

The new extended depth of focus IOL provided reasonable unaided near and distance vision, as well as spectacle independence and patient satisfaction. Some optical side effects were reported in the early postoperative period.

[J Refract Surg. 2019;35(7):426–433.]

Extended depth of focus (EDOF) intraocular lenses (IOLs) are an emerging technology on the market of premium IOLs. Compared to traditional multifocal lenses that have mostly two or three focal points, in EDOF technology, the focus is extended longitudinally with the main aim of offering range of vision from far to intermediate, providing a more natural and smoother defocus curve.1–3

Although most of the traditional multifocal lenses in the past primarily focused on improvement of near vision, intermediate working distance is becoming more important with the increased use of computers, smartphones, and tablets. EDOF technology also claims to reduce optical side effects and improve the quality of distance vision, which can be an issue with traditional multifocal lenses that split light and result in reduced contrast sensitivity.2,3 A few commercially available IOL models can be classified as EDOF, and each of them employs a different principle to achieve the extended range of vision.3

In this study, we evaluated our initial experience with bilateral implantation of a new EDOF IOL, the AT LARA 829MP (Carl Zeiss Meditec AG, Jena, Germany). This IOL received Conformité Européene (CE) marking in 2017 and is based on a diffractive design principle to continuously extend the depth of focus. The lens has an aberration-neutral aspheric design and optimized chromatic aberration to improve the quality of vision. Early postoperative clinical outcomes and patient-reported outcomes are presented in this study.

Patients and Methods

This retrospective study was deemed exempt from full review by the Committee of Human Research (the institution-specific name for the institutional research board) at the University of California, San Francisco, because it used only retrospective, deidentified patient data. Informed consent to undergo refractive lens exchange or cataract surgery was obtained from all patients prior to surgery. As a part of informed consent, all patients agreed to the use of their deidentified data for research purposes and statistical analysis.

All data of patients who underwent a refractive lens exchange or cataract surgery with bilateral implantation of the AT LARA 829MP IOL between September 2017 and September 2018 and attended 1-week, 1-month, and 3-month postoperative visits were extracted from Optical Express electronic database. Inclusion criteria for the study were: primary procedure with no previous refractive surgery, emmetropic aim in each eye, preoperative corneal astigmatism of 1.50 diopters (D) or less (keratometry from IOLMaster; Carl Zeiss Meditec AG, Jena, Germany) in each eye and absence of any ocular pathology (other than refractive error or cataract).

Preoperative examination included detailed ophthalmic examination with the manifest and cycloplegic refraction, uncorrected (UDVA) and corrected (CDVA) distance visual acuity, uncorrected near visual acuity (UNVA), slit-lamp evaluation, dilated funduscopy, autorefraction and tonometry (Tonoref II; Nidek Co. Ltd., Tokyo, Japan), corneal tomography (Pentacam software version 1.21r43; Oculus Optikgeräte GmbH, Wetzlar, Germany), wavefront aberration measurement (iDesign Advanced WaveScan System; Johnson & Johnson Vision Care, Inc., Santa Ana, CA), endothelial cell count (SP 2000P specular microscope; Topcon Corporation, Tokyo, Japan), biometry (IOLMaster 700 software version 1.18; Carl Zeiss Meditec AG), and retinal optical coherence tomography (Cirrus 4000/500 OCT; Carl Zeiss Meditec AG). Distance visual acuity was measured at 3 meters with a logarithmic acuity chart (with refractions corrected for 3 meters testing distance) and near reading acuity was measured with an Early Treatment Diabetic Retinopathy Study (ETDRS) reading chart normalized for 40 cm distance and recorded in Snellen distance equivalent.

Postoperatively, patients were evaluated at 1 day, 1 week, 1 month, and 3 months. At each visit, refraction, CDVA, UDVA, and UNVA were measured and any adverse events were noted. At the preoperative and 1-and 3-month postoperative follow-up visits, patients completed a purpose-developed satisfaction questionnaire. The methodology of obtaining the questionnaire has been previously described.4

Surgical Technique

Lens calculations were performed using the IOLMaster 700 series software version 1.18 (Carl Zeiss Meditec AG) with the use of Haigis formula5 (constants A0 = +0.978, A1 = +0.400, and A2 = +0.100). The refractive aim in all eyes was postoperative emmetropic spherical equivalent. Intraocular surgeries were performed with the assistance of a femtosecond laser (Catalys Precision Laser System; Johnson & Johnson Vision Care, Inc.). The size of the capsulorrhexis was 4.8 mm and it was centered on the pupil. Corneal incisions were made with an angled slit knife (2.75-mm incision size) and were typically placed on the steepest meridian. In patients with corneal astigmatism between 0.75 and 1.50 D, astigmatic keratotomy (two paired symmetrical intrastromal incisions) was performed with the femtosecond laser. The fully preloaded IOL (AT LARA 829MP IOL with BLUEMIXS 180 injector/cartridge set; Carl Zeiss Meditec AG) was implanted into the capsular bag in all cases. Postoperatively, patients were instructed to instill one drop of levofloxacin 0.5% four times daily for 2 weeks, one drop of dexamethasone 0.1% four times daily for 2 weeks, and one drop of ketorolac trometamol 0.5%, four times daily for 1 month.

IOL

The AT LARA 829MP (Figure A, available in the online version of this article) is a hydrophilic IOL (25% water content) with hydrophobic surface properties. The IOL has a four-point haptic fixation, 6-mm optic diameter, and 11-mm overall length, and it is available in the −10.00 to +32.00 D range with 0.50-D increments. A toric version of the lens is now available (AT LARA 929MP), offering cylinder correction up to 12.00 D, but was not used in this evaluation. The lens is preloaded (BLUEMIXS 180 injector), and compatible with incisions down to 1.8 mm.

AT LARA 829MP IOL and the implantation with BLUEMIXS 180 injector (Carl Zeiss Meditec AG, Jena, Germany) (photographs provided by Florian Kretz, MD).

Figure A.

AT LARA 829MP IOL and the implantation with BLUEMIXS 180 injector (Carl Zeiss Meditec AG, Jena, Germany) (photographs provided by Florian Kretz, MD).

The AT LARA is based on a diffractive principle, is aspheric, and has an aberration-neutral and chromatic aberration-correcting optical design. Smooth micro-phase manufacturing technology is used to reduce manufacturing imperfections and limit light scatter. In addition to a distance focal point, the IOL has two additional foci of 1.90 and 0.95 D for far-intermediate and near-intermediate distances.

Statistical Analysis

Preoperative and postoperative clinical parameters were described by means and standard deviation or percentages. For the calculation of change in the manifest spherical equivalent over time, the repeated measures analysis of variance test was applied. The Friedman test was used for the calculation of change in visual phenomena between preoperative and postoperative visits. The chi-square test was used to compare percentages. All calculations were performed using Microsoft Office Excel 2011 (Microsoft Corporation, Redmond, WA) and STATISTICA 9.0 (StatSoft Inc., Tulsa, OK) software.

Results

The study involved 586 eyes of 293 patients with a mean age of 58.7 ± 7.3 years. Sixty-one patients (20.8%) had some cataract changes (usually mild with CDVA not worse than 20/32), whereas the remaining 232 patients (79.2%) underwent the procedure for refractive purposes in the absence of cataract. Table 1 presents the basic clinical data of the study group.

Demographics and Preoperative and Postoperative Clinical Data

Table 1:

Demographics and Preoperative and Postoperative Clinical Data

Refractive Predictability and Stability

Mean preoperative and postoperative sphere, cylinder, and manifest spherical equivalent (MSE) are presented in Table 1. At 3 months, 86.7% and 98.3% of eyes were within ±0.50 and ±1.00 D of emmetropia, respectively. Figure 1A shows the distribution of postoperative MSE.

(A) Postoperative manifest spherical equivalent. (B) Predictability of manifest spherical equivalent (Haigis formula predicted manifest spherical equivalent vs achieved manifest spherical equivalent). (C) Stability of manifest spherical equivalent over time. The solid line represents the mean manifest spherical equivalent and the dashed line represents ± one standard deviation. The change between each postoperative visit was statistically significant (analysis of variance P < .01). (D) Postoperative refractive cylinder. (E) Postoperative monocular uncorrected distance visual acuity vs corrected distance visual acuity. (F) Difference between postoperative uncorrected distance visual acuity and corrected distance visual acuity. (G) Binocular uncorrected distance visual acuity. (H) Monocular and binocular uncorrected near visual acuity. (I) Change in corrected distance visual acuity.

Figure 1.

(A) Postoperative manifest spherical equivalent. (B) Predictability of manifest spherical equivalent (Haigis formula predicted manifest spherical equivalent vs achieved manifest spherical equivalent). (C) Stability of manifest spherical equivalent over time. The solid line represents the mean manifest spherical equivalent and the dashed line represents ± one standard deviation. The change between each postoperative visit was statistically significant (analysis of variance P < .01). (D) Postoperative refractive cylinder. (E) Postoperative monocular uncorrected distance visual acuity vs corrected distance visual acuity. (F) Difference between postoperative uncorrected distance visual acuity and corrected distance visual acuity. (G) Binocular uncorrected distance visual acuity. (H) Monocular and binocular uncorrected near visual acuity. (I) Change in corrected distance visual acuity.

Figure 1B depicts the predictability of MSE at 3 months. The scattergram shows a tight relationship between attempted and achieved MSE with a coefficient of determination close to 1.

Figure 1C shows the refractive stability over time. Initially, postoperative MSE was slightly myopic, and a small hyperopic shift occurred up to 3 months postoperatively, where the MSE was close to plano (−0.05 ± 0.39 D). The mean prediction error (the difference between attempted predicted MSE as estimated by the Haigis formula and achieved MSE) was −0.07 ± 0.41 D at 3 months. Figure 1D depicts the residual postoperative refractive cylinder. At 3 months, 73% of eyes had the magnitude of refractive cylinder of 0.50 D or less.

UDVA

Figure 1E shows the comparison of postoperative monocular UDVA and CDVA. Of all eyes, 90.8% at 3 months achieved monocular UDVA of 20/25 or better, whereas all eyes had postoperative CDVA 20/25 or better and 57.5% had postoperative UDVA the same as postoperative CDVA (Figure 1F). Binocularly (Figure 1G), the percentage of patients who achieved UDVA of 20/25 or better was 97.4%.

Cumulative UNVA is shown in Figure 1H. The UNVA of 20/50 or better was measured in 84.6% of eyes monocularly and 91.6% of patients binocularly. The mean logMAR values for UDVA and UNVA are shown in Table 1.

Change in CDVA

Postoperatively, patients maintained good CDVA with the mean logMAR value of −0.05 ± 0.06 at 3 months (between 20/20 and 20/16). Figure 1I shows the mean change between preoperative and postoperative CDVA.

At the 3-month visit, 13 eyes (2.2%) of 9 patients had CDVA reduced by two lines for the following reasons: dryness/ocular surface issues (7 eyes), posterior capsule opacification (2 eyes), and presence of central serous retinopathy (1 eye). The cause was not identified in 3 eyes. No eye with CDVA loss had corrected visual acuity of worse than 20/25.

Patient-Reported Outcomes

A patient experience questionnaire was completed by 85% of patients preoperatively, 69.6% at 1 month and 66.6% at 3 months. Table 2 summarizes the main outcomes of the questionnaire. The percentage of patients who were very satisfied or satisfied with their vision at 3 months was 90.3%. Additionally, 90.8% of patients stated that their vision met or exceeded their expectations.

Patient Experience Questionnaire

Table 2:

Patient Experience Questionnaire

The percentage of patients having little or no difficulty with night driving was 78.5% at 3 months. Significant difficulty with night driving (“a lot of difficulty” or “unable to do the task because of vision”) was reported by 6.8% patients. The majority of patients (90.3% at 3 months) reported little or no difficulty with tasks requiring near vision, whereas 92.3% at 3 months indicated little or no difficulty with tasks requiring distance vision. The percentage of patients having significant difficulty with near vision tasks was 2.1% at 3 months, whereas only 0.5% of patients reported significant difficulty with distance vision.

When questioned about postoperative spectacle/contact lens wear, 83.6% of patients at 3 months reported not wearing any correction for near vision. For the distance vision, the percentage of patients not requiring any correction at all was 95.4%.

The difficulty with visual phenomena was rated on a discrete scale from 1 (no difficulty) to 7 (severe difficulty). Table A (available in the online version of this article) presents the mean scores for optical side effects calculated for each follow-up point and the percentage of patients with postoperative significant difficulty or preoperative to postoperative increase in difficulty with optical side effects. There was a statistically significant increase in glare, halo, and starburst between the preoperative and 1-month postoperative visits (1.2 to 1.4 units), and subsequent mean decrease between the 1- and 3-month visits (0.2 to 0.3 units).

Visual Phenomenaa

Table A:

Visual Phenomena

Postoperative visual symptoms were associated with postoperative satisfaction. For example, of all patients reporting significant glare at 3 months, only 46.2% were very satisfied or satisfied with their postoperative vision, whereas 93.4% were satisfied in the group of patients that experienced, none, mild, or moderate symptoms (P < .01).

Intraoperative and Early Postoperative Adverse Events

There was one intraoperative adverse event where a small posterior capsule tear with vitreous in the anterior chamber was noted during surgery. A limited anterior vitrectomy was performed and the surgeon was able to implant the IOL into the capsular bag without further complications or consequences.

Postoperative events included cystoid macular edema diagnosed by optical coherence tomography, which occurred in 15 eyes (incidence 2.6%) of 10 patients and all resolved without sequelae.

Other adverse events included a case of bilateral central serous retinopathy, which was still resolving at the time of this study with the last available CDVA of 20/20 (right eye) and 20/25 (left eye) at the 4-month postoperative visit. One patient developed synechiae over the right pupil due to ongoing inflammation in the early postoperative period, which required treatment with an Nd:YAG laser 1 month postoperatively. The patient had no recurrence of inflammation and the final CDVA at 6 months was 20/16.

There have been no explants of the AT LARA IOL due to unwanted optical side effects or other reasons in the early postoperative period. In those patients for whom the preoperative intention was to perform bilateral implantation of the study IOL, no patient declined implantation of the AT LARA in their second eye.

Discussion

There is currently a limited number of lenses that can be classified as EDOF. The most commonly used and the only U.S. Food and Drug Administration–approved EDOF lens (Tecnis Symfony; Johnson & Johnson Vision Care, Inc.)4,6–23 is based on a diffractive principle, whereas other technologies have been used for EDOF IOLs, such as a progressive multifocal IOL,17,18,24,25 a bioanalgic IOL,3,26 or IOLs based on the pinhole effect.3,27–29

The AT LARA IOL is based on a diffractive design with chromatic correction and manufacturing technology designed to minimize light scatter. To date, there is only one study in the peer-reviewed literature presenting outcomes of 11 patients bilaterally implanted with this new EDOF.30 This study found a good range of focus and stable visual acuity for intermediate distances.

In the current study, we achieved a good refractive predictability with 86.7% of eyes within ±0.50 D of emmetropia. We observed a small hyperopic shift during the 3-month follow-up. Slight refractive changes have been reported with the IOLs manufactured on the same platform,31–33 but the refraction usually stabilized within the first few postoperative months. A hyperopic shift has also been commonly reported for IOLs of other manufacturers34–36 as a result of early postoperative keratometric changes and capsular contractions moving the IOL posteriorly.

Patients had excellent distance vision, with 87.5% having 20/20 or better binocular UDVA at 3 months and 95.4% reporting no use of optical correction for distance vision. However, compared to conventional multifocal lenses, the near vision with EDOF IOLs may not be as good. In the published literature, whenever UNVA was directly compared to bifocal or trifocal lenses, EDOF IOLs were slightly inferior.7,8,13,14,16,20,23,37 Typically, there was at least one Snellen line difference in binocular near vision between EDOF IOLs and traditional bifocal or trifocal IOLs.8,13,16 To overcome this, many authors considered a micro-monovision approach or even combining EDOF IOLs with other types of lenses to achieve better performance for near vision.4,7,11,15,16,21,27 However, this can induce additional optical side effects and slightly impair distance vision, which might limit the main benefits of EDOF IOLs.

In our study, we included only patients for whom the refractive goal was emmetropia and reasonable near visual acuity of 0.26 logMAR binocularly (between 20/32 and 20/40) was achieved. More than 90% of patients attained binocular UNVA of 20/50 or better. A better indication of a patient's near vision achievements might be the outcomes of postoperative questionnaire, where 91.2% of patients at 1 month and 83.5% at 3 months claimed to be spectacle/contact lens free for near vision. The decrease between the two follow-up times may be due to a slight hyperopic shift, but these patients mostly reported only occasional use of near vision correction (up to 25% of the time during day-time). When questioned about difficulties performing near vision tasks, more than 90% of patients claimed not to have any difficulty or only a little difficulty. The question involved common tasks related to the use of close-up vision and intermediate distances (eg, cooking, fixing things around the house, sewing, using hand tools, or working with a computer).

Comparison of near vision performance to other EDOF IOLs is difficult because studies use different reading chart and a variety of testing methods4,7,9,11,15,16,21–23,27 and authors mostly report outcomes of micro-monovision4,7,11,15,16,21,27 or, despite of the intention for emmetropia, often report slightly myopic postoperative outcomes.9,11,22,23 For example, the largest study of the Tecnis Symfony comprises 411 patients, of whom 299 were bilaterally targeted for emmetropia.11 Despite the emmetropic aim, authors reported a mean postoperative MSE of −0.30 ± 1.13 D (4 to 6 months postoperatively) and binocular UNVA similar to our current outcomes (0.21 ± 0.1 logMAR).11

Optical side effects in this study were evaluated preoperatively and 1 and 3 months postoperatively on a scale from 1 (no difficulty) to 7 (severe difficulty). We found an increase in glare, halo, and starburst between the preoperative and 1-month visit, and a slight but statistically significant decrease between the 1- and 3-month visit (Table A). However, optical side effects at early postoperative visits are difficult to interpret because they can be associated with factors other than the IOL design. These include early postoperative inflammation, corneal edema, dry eye, presence of superficial punctate keratitis, and a slight refractive error. Further improvement in optical side effects might be expected with longer follow-up. Studies that present visual phenomena for other EDOF IOLs at approximately 6 months (mostly for Tecnis Symfony) show a varying degree of phenomena on different scales.7,11,13,21,22,27

This study has several limitations. We only present early postoperative outcomes for up to 3 months of follow-up. Adverse events and long-term optical side effects could not be fully addressed. The lack of intermediate visual acuity measurements is also a limitation of this retrospective study, but the patient-reported outcomes referring to intermediate vision tasks (cooking or fixing things around house) are more patient centric than the actual intermediate vision measurements. Selection bias might have been introduced by having a significant portion of patients with preoperative hyperopia, but hyperopic refractive error is common in presbyopic patients who undergo lens implantation mostly for refractive purposes. Hyperopic patients are also more likely to appreciate near vision gain postoperatively, which could be the reason for great patient-reported outcomes. Despite of these drawbacks, the study presents clinical and patient-reported outcomes in a reasonable sample of patients with a wide range of preoperative refractive errors. The EDOF IOL principle is still relatively new and most of the currently available studies of different EDOF designs have a relatively small sample size.6–10,12–16,19–22,25,27,29

We achieved good patient satisfaction, high rates of spectacle independence, and reasonable refractive predictability and visual outcomes. Even with the EDOF IOLs, there is still a portion of patients who can have postoperative visual symptoms, but these typically improve with time. We believe EDOF lenses have a great potential for the future, but careful patient counseling is necessary in terms of achieved near vision and the possibility of having optical side effects remains.

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Demographics and Preoperative and Postoperative Clinical Data

ParameterPreoperative1 Month Postoperative3 Month Postoperative
Demographic
  No. of patients (eyes)293 (586)293 (586)293 (586)
  Age (y), mean ± SD (range)58.7 ± 7.3 (46 to 81)
  Gender, male/female (%)54.3/45.7
  Myopia hyperopia (%)10.8/89.2
  Axial length (mm), mean ± SD (range)23.33 ± 1.07 (20.89 to 28.12)
  Power of implanted IOL (D), mean ± SD (range)21.82 ± 2.98 (9.5 to 31.0)
Clinical, mean ± SD (range)
  Sphere (D)+1.50 ± 1.95 (−7.00 to +7.25)+0.12 ± 0.42 (−2.00 to +1.50)+0.18 ± 0.4 (−0.75 to +2.00)
  Cylinder (D)−0.51 ± 0.40 (−2.25 to 0.00)−0.52 ± 0.45 (−2.50 to 0.00)−0.46 ± 0.41 (−2.75 to 0.00)
  MSE (D)+1.24 ± 1.95 (−7.13 to +6.75)−0.14 ± 0.43 (−2.38 to +1.25)−0.05 ± 0.39 (−1.88 to +1.63)
  UDVA monocular (logMAR)0.48 ± 0.32 (−0.08 to 1.60)0.04 ± 0.13 (−0.18 to 0.80)0.01 ± 0.11 (−0.18 to 0.70)
  UDVA binocular (logMAR)−0.03 ± 0.09 (−0.20 to 0.40)−0.05 ± 0.09 (−0.18 to 0.30)
  UNVA monocular (logMAR)0.93 ± 0.26 (0.10 to 1.60)0.32 ± 0.15 (−0.08 to 1.20)0.33 ± 0.16 (−0.08 to 0.90)
  UNVA binocular (logMAR)0.26 ± 0.14 (−0.08 to 0.90)0.26 ± 0.14 (−0.18 to 0.78)
  CDVA (logMAR)−0.05 ± 0.06 (−0.18 to 0.22)−0.04 ± 0.07 (−0.18 to 0.4)−0.05 ± 0.06 (−0.18 to 0.1)

Patient Experience Questionnaire

Thinking about your vision during the last week, how satisfied are you with your vision? (without the use of glasses or contact lenses)
TimeVery SatisfiedSatisfiedNeitherDissatisfiedVery Dissatisfied

1 month48.0%41.2%5.4%4.4%1.0%
3 months53.8%36.4%5.6%3.1%1.0%

Has your overall vision turned out to be:
TimeMuch better than expectedBetter than expectedAbout what I expectedWorse than expectedMuch worse than expected

1 month43.6%25.0%25.5%5.9%0.0%
3 months42.1%26.2%22.6%8.2%1.0%

Because of your eyesight, how much difficulty do you have driving at night?
TimeNo difficultyA little difficultyModerate difficultyA lot of difficultyUnable to do this because of visionDon't do this for other reasons

1 month50.5%24.5%12.7%5.9%1.5%4.9%
3 months48.7%29.7%12.3%5.1%1.5%2.6%

Because of your eyesight, how much difficulty do you have doing work or hobbies that require you to see well up close, such as cooking, fixing things around the house, sewing, using hand tools, or working with a computer?
TimeNo difficultyA little difficultyModerate difficultyA lot of difficultyUnable to do this because of visionDon't do this for other reasons

1 month75.0%17.6%3.9%2.0%0.5%1.0%
3 months68.2%22.1%7.2%1.5%0.5%0.5%

Because of your eyesight, how much difficulty do you have taking part in active sports or other outdoor activities that you enjoy (like hiking, swimming, aerobics, team sports, or jogging)?
TimeNo difficultyA little difficultyModerate difficultyA lot of difficultyUnable to do this because of visionDon't do this for other reasons

1 month85.8%8.3%2.0%0.0%0.0%3.9%
3 months84.6%7.7%2.1%0.5%0.0%5.1%

While you are awake, how often do you wear reading glasses or contact lenses in either eye to improve your near vision? Please indicate the percentage of the time.
TimeNever use any correctionUp to 25% of the time25% to 50% of the time50% to 75% of the time75% to 100% of the time

1 month91.2%5.9%1.5%1.0%0.5%
3 months83.6%11.3%1.0%2.6%1.5%

While you are awake, how often do you wear glasses or contact lenses in either eye to improve your distance vision? Please indicate the percentage of the time.
TimeNever use any correctionUp to 25% of the time25% to 50% of the time50% to 75% of the time75% to 100% of the time

1 month96.6%2.5%0.0%0.0%1.0%
3 months95.4%3.6%0.5%0.0%0.5%

Visual Phenomenaa

TimeGlareHaloStarburstGhosting/Double Vision
Preoperative1.29 ± 0.831.21 ± 0.721.27 ± 0.931.13 ± 0.45
  1 month2.49 ± 1.652.60 ± 1.752.46 ± 1.821.43 ± 0.96
  3 months2.18 ± 1.482.29 ± 1.732.25 ± 1.661.30 ± 0.70
   Pb< .01< .01< .01.22
   P (preoperative to 1 month)< .01< .01< .01
   P (preoperative to 3 months)< .01< .01< .01
   P (1 to 3 months).02.01.04
Postoperative significant difficultyc
  1 month4.9%8.8%9.3%1%
  3 months6.7%8.2%7.2%0.5%
Preoperative to postoperative increase in difficulty by more than 2 scores
  Preoperative to 1 month26.9%30.2%27.4%4%
  Preoperative to 3 months18.4%24.5%22.7%4.4%
Authors

From the Department of Ophthalmology, University of California, San Francisco, California (SCS, JMS); Optical Express, United Kingdom, Glasgow, United Kingdom (SCS, DT, JAV, SJH); and F.I. Proctor Foundation, University of California, San Francisco, California (JMS).

Dr. Steven Schallhorn is a chief medical officer for Carl Zeiss Meditec AG and a chairman of the medical advisory board for Optical Express. The remaining authors have no financial or proprietary interest in the materials presented herein.

AUTHOR CONTRIBUTIONS

Study concept and design (SCS, DT, JAV, SJH, JMS; data collection (SJH); analysis and interpretation of data (SCS); writing the manuscript (SCS, DT, SJH); critical revision of the manuscript (SCS, JAV, JMS); supervision (SCS, DT, JAV, SJH, JMS)

Correspondence: Steven C. Schallhorn, MD, 11730 Caminito Prenticia, San Diego, CA 92131. E-mail: scschallhorn@yahoo.com

Received: October 23, 2018
Accepted: May 30, 2019

10.3928/1081597X-20190530-01

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