Visual outcomes following bilateral implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens

doi:10.21203/rs.3.rs-3806620/v1

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Visual outcomes following bilateral implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens

https://doi.org/10.21203/rs.3.rs-3806620/v1

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published 24 Jul, 2024

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Purpose: To evaluate the clinical outcomes following bilateral implantation of the AcrySof™ IQ Vivity™ toric extended depth of focus (EDOF) intraocular lens (IOL).

Design: Prospective interventional case series

Methods: Patients with bilateral significant cataracts and pre-existing corneal astigmatism underwent cataract surgery and implantation with the AcrySof™ IQ Vivity™ Toric IOL. Dominant eyes were targeted at emmetropia and non-dominant eyes at -0.50D. Primary endpoints were binocular uncorrected distance (UDVA), intermediate (UIVA at 66cm) and near (UNVA at 40cm) acuities at 3 months. Secondary outcomes were corrected distance (CDVA), distance corrected intermediate (DCIVA) and distance corrected near (DCNVA), refractive predictability, rotational stability, binocular defocus curve, contrast sensitivity, Questionnaire for Visual Disturbances (QUVID) and VF-14 questionnaire scores. All visual acuities were converted to logarithm of minimum angle of resolution (logMAR) for analysis.

Results: 30 patients underwent uneventful phacoemulsification. The mean binocular UDVA, UIVA and UNVA were 0.06 + 0.12, 0.11 + 0.10 and 0.26 + 0.10 respectively. The mean refractive spherical equivalent (MRSE) for dominant and non-dominant eyes were -0.07D + 0.27 and -0.12D +0.54 respectively. 82.4% of dominant eyes and 84.6% of non-dominant eyes within 0.50D of target respectively. The mean IOL rotation was 3.85° + 5.09 with 86.7% of eyes with less than 5° of rotation. 26.7%, 20% and 36.7% of patients reported starbursts, haloes and glare respectively. The mean VF-14 score was 91.77.

Conclusion: Bilateral implantation of the AcrySof™ IQ Vivity™ Toric IOL resulted in very good unaided visual acuities for far and intermediate distance with functional near vision. Dysphotopsias were reported but despite this, a high level of visual function was achieved.

The relentless pursuit for presbyopia correction after cataract surgery has resulted in continuous innovation in the field of intraocular lens (IOL) technology. This segment of presbyopia correcting intraocular lenses (PCIOL) has seen in recent years, the introduction of extended depth of focus (EDOF)[1] IOLs which has created another option for patients seeking more spectacle independence after cataract surgery.

The conventional design for PCIOLs have utilised diffractive or refractive technology to achieve multifocality but this results in photic phenomena such as haloes, starbursts and glare[2]. Together with the loss of contrast sensitivity also inherent to such IOL designs, these phenomena restrict the use of such IOLs in certain individuals who are more demanding or in those who have had previous refractive surgery or other ocular pathology.

A new EDOF IOL entered the market recently which utilises a novel optical design to achieve an extended range of vision for the patient. The AcrySof™ IQ Vivity™ (Alcon Laboratories, Inc.) is a non-diffractive UV-absorbing and blue light filtering hydrophobic aspheric IOL which has been reported to provide an extended range of vision with a low incidence of visual disturbances. In the United States Food and Drug Administration (USFDA) trials[3], all eyes had refractive target of emmetropia and the intermediate and near vision were significantly better than a monofocal IOL but near vision was not as good as what can be achieved with a multifocal IOL. In another study of the AcrySof™ IQ Vivity™ IOL which artificially induced low myopia in the non-dominant eye, a target of -0.50D

to -1.00D significantly improved near vision[4]. The use of monovision to extend the range of patients after cataract surgery has been a well-documented approach[5, 6] but functional near vision may not be achieved with the use of monofocal IOLs. A mini-monovision approach using the AcrySof™ IQ Vivity™[7–9] has been described with the non-dominant eye targeted from − 0.25D to -0.75D and with good near vision achieved.

The objective of this study is to evaluate the visual outcomes following bilateral implantation of the AcrySof™ IQ Vivity™ Toric IOL using the mini-monovision approach in a cohort of Asian patients.

Study Design

This is a prospective interventional case series of patients with bilateral cataracts and significant corneal astigmatism who desired more spectacle independence after cataract surgery. Enrolment of patients took place at LEC Eye Centre, a private ophthalmic day surgical centre in Ipoh, Malaysia from April 2022 to January 2023.

The inclusion criteria were patients aged 18 years or older with bilateral significant cataracts and significant corneal astigmatism. Exclusion criteria were patients with history of prior refractive surgery, amblyopia, strabismus, ocular co-morbidity which would significantly impact on final visual acuity or pre-existing zonular weakness, or capsular compromise as seen during preoperative examination.

This study was approved by the Medical Research and Ethics Committee of Malaysia and all study procedures followed the tenets of the Declaration of Helsinki. Informed consent was obtained from all individual participants of the study.

Intraocular lens

As previously described, the AcrySof™ IQ Vivity™ IOL utilises a - wavefront-shaping central 2.2mm zone which stretches and shifts the wavefront of light to achieve an elongated focus. This study specifically used the toric version of the IOL which has a cylindrical power at IOL plane of 1.00D (DFT215), 1.50D (DFT315), 2.25D (DFT415), and 3.00D (DFT515).

Preoperative assessments

All patients received full ophthalmic evaluation, slit lamp biomicroscopy and dilated fundus examination. Biometry measurements were carried out using the Lenstar LS900 (Haag-Streit, Switzerland) and VERION image-guided system (Alcon Laboratories, Inc., Fort Worth, Texas, United States.) digital marker guiding system and corneal topography was performed with the Oculyzer (Alcon Laboratories, Inc., Fort Worth, Texas, United States). IOL power calculation for spherical prediction was performed using the Barrett Universal II formula and for astigmatic correction using the online Barrett Toric Calculator V1.05 (www.apacrs.org) with the integrated-K function utilising keratometry readings from the Lenstar, VERION and Oculyzer machines. Eye dominance was determined using the Miles test and the dominant eye was targeted for emmetropia (IOL power selected with residual spherical equivalent[SE] closest to but not more than 0D) and the non-dominant eye was targeted for -0.50D (IOL power selected with residual SE closest to but not less than -0.50D). The lens factor (LF) used was based on the value provided by the online calculator.

Surgical technique

All surgeries were performed by a single surgeon through a 2.2mm temporal corneal incision using a standard ‘stop and chop’ phacoemulsification technique with the CENTURION® Vision System (Alcon Laboratories, Inc., Fort Worth, Texas, United States) under topical anaesthesia. Intraoperative toric IOL alignment was performed using the VERION image-guided system (Alcon Laboratories, Inc., Fort Worth, Texas, United States.) digital marker guiding system.

Postoperative assessment

Patients were examined at 1 day, 1 week, 1 month and 3 months. Monocular and binocular uncorrected (UDVA) and corrected distance visual acuities (CDVA) were measured with the Snellen chart at 6m, uncorrected (UIVA) and distance corrected intermediate visual acuities (DCIVA) were measured with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66cm and uncorrected (UNVA) and distance corrected near acuities (DCNVA) were measured with an ETDRS chart at 40cm. All Snellen acuities were converted to logarithm of minimal angle of resolution (logMAR). At 3 months, manifest refraction was carried out and distance corrected monocular and binocular defocus curves were produced with 0.5D increments (range +2.0D to -4.0D) under photopic lighting conditions.

Patients underwent slit lamp biomicroscopy at all visits and dilated fundoscopy at 1 month and 3 months. Toric IOL position was assessed at 1 month postoperatively and measured by aligning the narrow slit lamp light beam with the IOL markings and subsequently aligning the beam with the toricCAM application (Apple Inc.) on the iPhone to determine the axis of the IOL. Analysis of astigmatism correction was carried out using the ASCRS Double Angle Plot Tool (https://ascrs.org/tools/astigmatism-double-angle-plot-tool)[10].

Contrast sensitivity was measured at the 3-month visit using the CSV-1000E (Vector Vision Co, Greenville, Ohio, USA) and was conducted under photopic and mesopic conditions at spatial frequencies of 3, 6, 12 and 18 cycles per degree (cpd).

Visual disturbances and visual function assessment

Visual disturbances were assessed using the Questionnaire for Visual Disturbances (QUVID)[11]and this questionnaire was administered at the 1 month and 3 month visits. The QUVID quantifies the frequency (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Most of the time, 4 = Always), severity (0 = None, 1 = A little, 2 = Mild, 3 = Moderate, 4 = Severe) and degree of bother (0 = Not bothered at all, 1 = Bothered a little bit, 2 = Bothered somewhat, 3 = Bothered quite a bit, 4 = Bothered very much) associated with 7 different symptoms – starbursts, haloes, glare, hazy vision, blurred vision, double vision and dark area in temporal vision.

The Visual Function Index 14 (VF-14)[12] questionnaire was used to assess patients’ visual function, and this was conducted at the 3 month visit. This questionnaire uses 14 questions based on activities of daily living and asks how much difficulty the patients have in performing these tasks with patients answers classified as None, A little, Moderate, Great deal or Unable to do and responses are quantified with a calculated score (range from 0 to 100).

Statistical analysis

All data was collected in a Microsoft Excel 2016 (Microsoft Corp., Redmond, USA) spreadsheet designed for the study and descriptive statistics including mean, standard deviation (SD), minimum and maximum values were calculated for all relevant parameters.

A total of 60 eyes of 30 patients were implanted with the AcrySof™ IQ Vivity™ toric IOL and this consisted of DFT215 (n = 28), DFT315 (n=20), DFT415 (n=5) and DFT515 (n=7). The baseline demographics and characteristics of all patients are shown in Table 1.

TABLE 1 Baseline preoperative characteristics

Patients

30 (60 eyes)

Age(years)

Mean + SD

Range

61.6 + 8.41

47 to 78

Gender

Female

Male

Race

Chinese

Indian

Eurasian

Corneal astigmatism(D)

Mean + SD

Range

1.12 + 0.62

0 to 2.28

CDVA(logMAR)

Mean + SD

Range

0.19 + 0.21

0 to 0.88

UDVA(logMAR)

Mean + SD

Range

0.65 + 0.52

0.10 to 1.60

BNVA(logMAR)

Mean + SD

Range

0.39 + 0.25

0 to 0.80

UNVA(logMAR)

Mean + SD

Range

0.62 + 0.27

0.10 to 1.00

(CDVA-best corrected distance visual acuity, UDVA-uncorrected distant visual acuity. BNVA-best corrected near visual acuity, UNVA-uncorrected near visual acuity. logMAR-logarithm of minimal angle of resolution)

Visual acuity and refractive outcomes

At 3 months, the mean monocular UDVA, UIVA and UNVA for dominant eyes were 0.10 + 0.12, 0.19 + 0.14 and 0.43 + 0.18 logMAR respectively. The mean monocular UDVA, UIVA and UNVA for non-dominant eyes were 0.18 + 0.24, 0.18 + 0.10 and 0.29 + 0.12 logMAR respectively. The mean binocular UDVA, UIVA and UNVA were 0.06 + 0.12, 0.11 + 0.10 and 0.26 + 0.10 logMAR respectively (Figure 1A). The mean monocular CDVA, DCIVA and DCNVA of all eyes were 0.05 + 0.10, 0.19 + 0.12 and 0.42 + 0.14 logMAR respectively. The mean binocular CDVA, DCIVA and DCNVA were 0.03 + 0.08, 0.12 + 0.10 and 0.35 + 0.10 logMAR respectively (Figure 1B). The mean refractive spherical equivalent (MRSE) for dominant and non-dominant eyes were -0.07D + 0.27 and -0.12D + 0.54 respectively. The mean absolute error (MAE) for dominant and non-dominant eyes was 0.21D + 0.17 and 0.37D + 0.40 respectively. 82.4% and 100% of dominant eyes were within 0.50D and 1.00D of target whereas 84.6% and 96.2% of non-dominant eyes were within 0.50D and 1.00D of target (Figure 1C and 1D).

Figure 2A shows double-angle plots of the preoperative corneal and postoperative refractive astigmatism. Preoperative corneal astigmatism centroid was 0.34D + 1.25 @ 92° and the postoperative refractive astigmatism centroid was 0.07D + 0.47 @ 112°. The centroid and mean absolute error of postoperative refractive astigmatism prediction (Figure 2B) was 0.06D + 0.47 @ 117° and 0.39D + 0.27 respectively. 67% had < 0.50D and 100% of eyes had < 1.00D of postoperative refractive astigmatism respectively. The mean postoperative refractive cylinder was 0.37D + 0.39 with 73% and 98% of eyes with < 0.50D and < 1.00D of target residual cylinder respectively (Figure 2C). The mean IOL rotation was 3.85° + 5.09 with 86.7% of eyes with less than 5° of rotation.

The monocular and binocular distance corrected defocus curves are illustrated in Figure 3.

Contrast sensitivity

The mean photopic contrast sensitivity at 3cpd, 6cpd, 12cpd and 18cpd were 1.73 + 0.20, 1.87 + 0.14, 1.50 + 0.17 and 1.02 + 0.16 respectively. The mean mesopic contrast sensitivity at 3cpd, 6cpd, 12cpd and 18cpd were 1.60 + 0.15, 1.80 + 0.20, 1.50 + 0.21 and 1.00 + 0.14 respectively. These were very similar and was comparable to the photopic contrast sensitivity of a series of monofocal eyes (n = 108) from the author’s previous study[13] as shown in Figure 4.

Visual disturbances, photic phenomena and visual function

Patients did report photic phenomena such as starbursts (n = 8), haloes (n = 6) and glare (n = 11) as well as visual disturbances such as hazy vision (n = 5) and blurred vision (n = 4) as shown in Figure 5A. When questioned about the degree of bother, the mean scores for starbursts (1.87), haloes (1.66), glare (1.63), hazy vision (0.75) and blurred vision (0.67) with no patient complaining of double vision or a temporal dark area (negative dysphotopsia){Figure 5B}.

VF-14 questionnaire results show that majority of patients had no to mild difficulties in performing activities of daily living with the exception of reading small print and sewing whereby patients reported mild to moderate difficulties (Figure 5C). The mean VF-14 score was 91.77.

The use of EDOF IOLs for presbyopia correction after cataract surgery is becoming increasingly popular with many different options available and each claiming to provide extended depth of focus using different optical principles to achieve this[14]. The ultimate objective is to provide the patient with an extended range of vision without significant compromises in visual function.

This study evaluated visual outcomes and patient reported outcomes following bilateral implantation of the AcrySof™ IQ Vivity™ EDOF toric IOL using a mini-monovision approach in a predominantly Asian population.

This study shows good binocular UDVA (0.06 ± 0.12 logMAR), UIVA (0.11 ± 0.10) and UNVA (0.26 ± 0.10). However, the visual acuities were somewhat worse than previously reported in other studies[7–9, 15]. This could be a result of non-optimisation of lens constant with consequent refractive surprise particularly in the non-dominant eyes (where the MRSE was − 0.12D) which would explain the poorer near vision compared with other similar studies. The differences could also be due to different testing conditions and comparison across studies and interpretation of results should be done with caution. The defocus curve of the non-dominant eyes does show a myopic shift due to the mini-monovision approach adopted and binocular summation is evident with improved binocular visual acuities at all distances.

Rotational stability of the AcrySof™ IQ Vivity™ IOL has been shown to be very good[16] and this is reflected in this study as well with 88.7% of eyes with less than 5° of rotation. Astigmatic correction using the Barrett toric calculator[17] has been shown to be very accurate and this is corroborated in this study as all eyes had less than 1.00D of residual refractive astigmatism postoperatively.

Results from the QUVID questionnaire indicates a larger proportion of patients reporting dysphotopsias compared with previous studies and this could be due to how the questionnaire was administered as these were not self-reported symptoms but instead patients were asked direct questions and shown illustrations of the different photic phenomena which may result in over-reporting[18]. Despite this, the majority of patients were not significantly bothered by these dysphotopsias. Patients also scored very well on the VF-14 quality of life questionnaire which is an indication of high visual function with only mild difficulties encountered when performing fine near tasks.

This study has several limitations as it is a single arm study with no comparison with alternative EDOF lenses. This study also recruited a relatively small number of patients which may result in selection bias and the short follow up of 3 months may not accurately reflect the long term outcomes particularly in relation to photic phenomena as neuro-adaptation will have a role to reduce the incidence of such phenomena over time[19].

In conclusion, our study has shown that bilateral implantation of this non-diffractive wavefront-shaping toric intraocular lens using a mini-monovision approach provides good functional vision at all distances with non-bothersome photic phenomena.

Conflicts of interest: Financial support was received for this investigator-initiated trial from Alcon Laboratories (Malaysia) Sdn Bhd. The funding source had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation of the manuscript; or the decision to submit the manuscript for publication.

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Competing interest reported. The study was funded by a grant from Alcon Malaysia

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Visual outcomes following bilateral implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens

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INTRODUCTION

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RESULTS

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References

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