Introduction

I deally, cataract surgery should provide perfect vison at all distances without optical complaints. Advances in intraocular lens (IOL) technology using multifocal designs offer expanding possibilities for achieving spectacle independence after cataract surgery. Although multifocal IOLs (mIOLs) may offer good visual performance at all distances, they carry risks of contrast sensitivity loss and photic phenomena. Recently, extended-depth-of-focus (EDOF) IOLs have been developed that primarily focus on good uncorrected distance and intermediate vision. The range of vision with EDOF IOLs can be increased by targeting for mini-monovision, wherein the dominant eye is targeted for emmetropia and the non-dominant eye targeted for -0.25 to -0.75D, improving the binocular uncorrected near visual acuity and thus increasing spectacle independency. ^, Furthermore, recent reports demonstrated that EDOF IOLs have an optical disturbance profile similar to monofocal IOLs, which assumedly contributes to the shifting popularity from multifocal to EDOF IOLs. ^, Various EDOF IOLs are available, either with a small aperture, aspherical continuous, refractive zonal or diffractive optical design. For the current study the Acunex Vario IOL AN6V (+1.5D addition) (Teleon Surgical B.V., Spankeren, the Netherlands), and the AcrySof IQ Vivity IOL DFT015 (Alcon Laboratories Inc., Fort Worth, United States of America) are explored. ^{, ,} The purpose of this study was to evaluate and compare the visual outcomes of these two EDOF IOLs when targeting for mini-monovision.

Methods

For this study, patients with bilateral cataracts were invited for participation if they expressed an unsolicited interest in an EDOF IOL, had a power calculation between +10.0 Diopters (D) and +30.0D, and an expected postoperative refractive astigmatism of ≤1.0D. Exclusion criteria were previous eye surgery, any significant ocular pathology that would limit the postoperative visual acuity <0.3 logMAR, extensive visual field loss, and cognitive or concentration disorders. Between May and December 2022, 32 participants from the University Eye Clinic of the Maastricht University Medical Center+ were enrolled. All patients signed informed consent before enrollment. This study was approved by the local medical ethics committee and executed in accordance with the principles of the Helsinki Declaration. The trial registration can be accessed at ClinicalTrials.gov under the identifier NCT05335408. We used the CONSORT checklist when writing our report.

Patients were randomized for bilateral implantation of the AN6V (Vario-group; intervention) or bilateral implantation of the DFT015 (Vivity-group; control). The randomization was performed using the algorithm of the data management platform (Castor, Amsterdam, the Netherlands) in blocks of 2 and 4. Patients and clinicians performing the postoperative assessments were blinded. Both IOLs are one-piece, foldable EDOF IOLs made of hydrophobic acrylic with a diopter range between +10.0 and +30.0D. The AN6V optic offers the extended depth of focus by a sector-shaped near vision segment of +1.5D located on the inferior IOL surface. The DFT015 provides extended depth of focus by its wavefront-shaping design. Power calculations were performed using the IOLMaster700 optical biometry (Carl Zeiss, Jena, Germany), the Barrett Universal-II (BU-II) formula, and the manufacturer recommended lens factor. All patients were targeted for mini-monovision, with the postoperative refraction in the dominant eye aimed closest to emmetropia and the non-dominant eye targeted for 0.25 to 0.75D of myopia.

Surgeries were performed by three experienced surgeons using a standard divide-and-conquer phacoemulsification technique or by performing femtosecond laser-assisted cataract surgery, with a 2.2 mm clear corneal incision. For cases of with-the-rule (WTR) astigmatism, the corneal incision was made superiorly, while for against-the-rule (ATR) astigmatism, the corneal incision was made temporally. The choice between immediate sequential bilateral or delayed sequential bilateral cataract surgery was based on the patient’s preference.

Preoperatively, patients underwent routine ophthalmological examination, including manifest subjective refraction, visual acuity measurements, slit lamp and funduscopy, optical biometry, and corneal topography (Pentacam HR, Oculus, Wetzlar, Germany). Postoperative assessments were planned at one week, one month, and three months. The three-month postoperative visit included a comprehensive ophthalmological assessment, with manifest refraction, uncorrected and corrected monocular and binocular visual acuities for distance (UDVA and CDVA), intermediate (UIVA and DCIVA), and near (UNVA and DCNVA). Visual acuity measurements were performed using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts, at distances of 4 m, 66 cm, and 40 cm. The last attempted line on the ETDRS chart was determined, until no further optotypes could be distinguished. The logMAR score was identified by adding the total number of correctly identified optotypes added to the score of the last attempted line. Functional vision assessment included binocular uncorrected and distance-corrected defocus curves, ranging from +2.0D to -4.0D with +0.50D increments, in photopic conditions. The defocus equivalent (DEQ) was calculated using:|Sphere + ½*Cylinder|+|½*Cylinder|. Contrast sensitivity was measured using the CSV-1000 (Greenville, Ohio, United States of America) in photopic and mesopic conditions, with and without glare. Reading speed (binocular uncorrected) was tested at 40 cm with the Radner reading chart in photopic conditions. Aberrometry measurements were conducted with the KR-1W Wavefront analyser (Topcon, Tokyo, Japan), and tilt and decentration analyses with the CASIA2 (Tomey Corp., Nagoya, Japan). At three months postoperatively, patient satisfaction, spectacle independence, and optical complaints were assessed using the Catquest-9SF, IOLSAT (Alcon Laboratories Inc., Fort Worth, United States of America), and QoV questionnaires with Likert scales ranging from zero (none/never) to four (severe/always). ^, Questionnaires were completed by patients at home, without involvement from surgeons or researches, to minimize bias.

Results

A total of 32 patients (64 eyes) were randomly assigned to the Vario-group or Vivity-group. One patient withdrew from the study because of anxiety for the cataract surgery. In total, 22 patients underwent ISBCS and 9 underwent DSBCS. The Vario-group comprised 16 patients (8 males and 8 females) and the Vivity-group comprised 15 patients (3 males and 12 females). Table 1 presents baseline characteristics. Baseline imbalances were observed for age, IOL power, and preoperative keratometric values of the dominant eye. In the statistical analyses of postoperative outcomes, age and IOL power were found to significantly influence the results and were included as covariates. Consequently, all P-values were adjusted for these covariates and reported as adjusted P-values (adjusted-P).

Table 2 summarizes the refraction and visual acuity outcomes at three months postoperatively subdivided into dominant and non-dominant eyes. The unstandardized B-coefficients, including standard error (SE) represent the difference between the two study groups after adjusting for covariates. The primary outcome parameter, UIVA, was non-inferior, with a 90%CI of -0.026 to 0.091. All other binocular visual acuity outcomes showed non-inferior outcomes as well, the 90% CI levels can be found in Supplemental Table 1. The postoperative refractive astigmatism was analyzed using double-angle plots shown in Figure 1 . An additional analysis of the monocular and binocular uncorrected visual acuity outcomes was conducted, shown in Table 3 , comparing the data excluding the outlier eyes with a postoperative corneal astigmatism >1.0D. This sensitivity analysis showed non-inferior binocular uncorrected visual acuity outcomes for the Vario-group compared to the Vivity-group.

Table 2

Refractive state and visual acuity outcomes .

Refractive state and visual acuity outcomes at 3 months postoperatively. Vectors, marked with a ^× , are calculated using vector analyses and further analyzed using Hotelling’s T-squared tests. The outcomes are corrected for the covariates age and IOL power, offering the unstandardized coefficient B, standard error, and adjusted P-value marked with an asterisk (*).

	Vario-group (n=16) Mean ± SD [range]	Vivity-group (n=15) Mean ± SD [range]	P	Unstandardized coefficient B (SE (B))*	Adjusted-P*
Binocular outcomes
UDVA (logMAR)	0.00 ± 0.14 [-0.20, 0.34]	0.08 ± 0.10 [-0.06, 0.22]	0.056	-0.014 (0.045)	0.753
UIVA (logMAR)	0.04 ± 0.11 [-0.10, 0.24]	0.15 ± 0.11 [-0.02, 0.36]	0.011	-0.052 (0.045)	0.264
UNVA (logMAR)	0.22 ± 0.17 [-0.10, 0.50]	0.31± 0.14 [0.14, 0.60]	0.104	-0.086 (0.071)	0.235
CDVA (logMAR)	-0.07 ± 0.09 [-0.20, 0.12]	0.00 ± 0.10 [-0.16, 0.18]	0.059	-0.028 (0.037)	0.459
DCIVA (logMAR)	0.06 ± 0.12 [-0.08, 0.34]	0.14 ± 0.14 [-0.04, 0.40]	0.105	-0.042 (0.056)	0.453
DCNVA (logMAR)	0.26 ± 0.12 [-0.10, 0.42]	0.35 ± 0.14 [0.12, 0.64]	0.055	-0.061 (0.059)	0.313
Monocular outcomes: Dominant eyes
Sphere (D)	0.09 ± 0.38 [-0.75, 0.75]	0.57 ± 0.51 [-0.25, 1.50]	0.006	-0.452 (0.197)	0.030
Cylinder (D) ×	-0.27 ± 0.54 [-1.25, 0.00]	-0.73 ± 0.79 [-1.75, 0.00]	0.001	NA	0.008
SEQ (D)	-0.12 ± 0.44 [-1.12, 0.75]	0.10 ± 0.48 [-0.50, 0.88]	0.181	-0.360 (0.202)	0.086
DEQ (D)	0.48 ± 0.46 [0.00, 1.50]	0.87 ± 0.31 [0.50, 1.50]	0.012	-0.110 (0.141)	0.442
UDVA (logMAR)	0.01 ± 0.09 [-0.16, 0.20]	0.18 ± 0.12 [0.04, 0.50]	<0.001	-0.104 (0.044)	0.027
CDVA (logMAR)	-0.02 ± 0.08 [-0.16, 0.14]	0.03 ± 0.09 [-0.16, 0.16]	0.106	-0.022 (0.033)	0.499
Prediction error (D)	0.11 ± 0.45 [-0.73, 1.12]	-0.14 ± 0.44 [-0.85, 0.50]	0.121	0.443 (0.192)	0.029
Monocular outcomes: Non-dominant eyes
Sphere (D)	-0.03 ± 0.35 [-0.75, 0.75]	0.05 ± 0.45 [-0.75, 1.00]	0.576	-0.111 (0.176)	0.535
Cylinder (D) ×	-0.15 ± 0.57 [-1.25, 0.00]	-0.67 ± 0.84 [-1.75, -0.25]	0.006	NA	0.141
SEQ (D)	-0.22 ± 0.33 [-0.75, 0.63]	-0.42 ± 0.41 [-1.25, 0.13]	0.131	0.072 (0.158)	0.651
DEQ (D)	0.50 ± 0.37 [0.00, 1.25]	0.95 ± 0.46 [0.25, 2.00]	0.005	-0.207 (0.166)	0.221
UDVA (logMAR)	0.04 ± 0.14 [-0.14, 0.34]	0.20 ± 0.12 [0.04, 0.48]	0.002	-0.088 (0.052)	0.098
CDVA (logMAR)	-0.02 ± 0.10 [-0.16, 0.22]	0.06 ± 0.11 [-0.08, 0.34]	0.039	-0.063 (0.046)	0.178
Prediction error (D)	-0.14 ± 0.34 [-1.02, 0.29]	0.01 ± 0.36 [-0.58, 0.72]	0.246	0.016 (0.145)	0.915

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