PURPOSE
To compare intraindividual differences in visual performance of two refractive extended–depth-of-focus (EDF) intraocular lenses (IOLs) targeted for emmetropia.
DESIGN
Prospective, randomized, patient- and examiner-masked intraindividual comparative study.
METHODS
A total of 40 patients (80 eyes) with bilateral age-related cataract underwent phacoemulsification with implantation of refractive EDF IOL in each eye: a wavefront-shaped refractive EDF IOL (DEN00V, Johnson & Johnson Vision) in one eye and a sector-segmented EDF IOL (AN6V, Teleon) in the fellow eye. After 3 months, monocular distance- corrected and uncorrected distance (CDVA/UDVA) intermediate (DIVA/UIVA) and near (DNVA/UNVA) visual acuity, refractive outcomes, defocus curves, contrast sensitivity, halometry, and subjective visual quality using questionnaires were compared.
RESULTS
In 37 patients (74 eyes), mean UDVA at 4 m, DIVA at 66 cm and UDNVA at 40 cm were 0.05 ± 0.10, 0.17 ± 0.11, and 0.31 ± 0.11 logMAR for the DEN00V and 0.06 ± 0.10, 0.15 ± 0.10, and 0.32 ± 0.11 logMAR for the AN6V, respectively, with no significant differences. A statistically significant difference was observed for the primary endpoint, UIVA, with 0.18 ± 0.13 logMAR for the DEN00V and 0.12 ± 0.09 logMAR for the AN6V. Nominal differences were observed for CDVA and UNVA with 0.01 ± 0.07 and 0.32 ± 0.12 logMAR for the DEN00V and–0.02 ± 0.07 ( P =.01) and 0.25 ± 0.10 ( P =.01) logMAR for the AN6V. Further nominal differences could be shown for contrast sensitivity under photopic and mesopic conditions. However, these differences did not remain statistically significant after adjustment for multiple comparisons.
CONCLUSIONS
Both IOLs demonstrated an extended range of functional vision, preserved contrast sensitivity, and minimal photopic phenomena. A statistically significant difference was observed for the primary endpoint, UIVA, favoring the AN6V.
W ith the growing diversity of intraocular lens (IOL) technologies, achieving spectacle independence has become an increasingly important objective in contemporary cataract surgery. In many instances, the procedure has evolved from a purely vision-restoring intervention to one that also addresses presbyopia correction. Although bilateral implantation of monofocal IOLs targeted for emmetropia generally yields high levels of patient satisfaction with distance vision, dependence on spectacles for near and intermediate visual tasks remains. ,
To achieve spectacle independence at all distances, multifocal intraocular lenses have been the first choice in the past. Multifocal IOLs either use a refractive or a diffractive design, a combination of both, or segmented asymmetric optics to allow adequate vision at all distances. Potential side effects of multifocal IOLs are photic phenomena (such as halos and glare), as well as a decrease in contrast vision compared to that achieved with monofocal lenses, due to separation or bending of light. ,
A better intermediate performance concerning contrast vision and optical side effects compared to multifocal IOLs can be reached using extended–depth-of-focus (EDF) lenses. These IOLs have an extended far focus area that reaches to the intermediate distance, providing high-quality vision over a continuous range of field, rather than distinct foci with blur in between. In the last few years, several technologies for EDF IOLs have appeared on the market. The spectrum ranges from small-aperture design, bioanalogic design, to diffractive and non-diffractive optics. ,,,, The disadvantage compared to monofocal lenses in all of these technologies is the potentially worse distance vision and contrast sensitivity as well as photic phenomena.
A refractive EDF lens type with an extended depth of vision has been introduced that promises an increased range of functional vision and less dysphotopsias compared to those associated with diffractive EDF lenses. These non-diffractive IOLs are believed to be a presbyopia-correcting alternative for people with existing corneal or macular pathologies, which would preclude them from receiving premium lenses because of the loss of light in the diffractive process. Two of these refractive IOLs are explored in the current study: the Acunex Vario IOL AN6V (Teleon Surgical), with a segment of +1.5 diopters (D) addition in the lower part of the IOL optic; and the PureSee IOL DEN00V (Johnson & Johnson Vision), with an aspheric, wavefront optimized power profile of the optic to induce an extended depth of focus. ,
The purpose of this study was to compare the visual outcomes and subjective impression of these EDF IOLs set for emmetropia in an intraindividual comparison design.
METHODS
This prospective, randomized, patient- and examiner-masked, single-center study enrolled patients between August 2024 and March 2025 with age-related, bilateral cataract scheduled for phacoemulsification and IOL implantation at the Hanusch Hospital in Vienna. Normal findings in the medical history and physical examination, unless the investigator considered an abnormality to be clinically relevant, were given in all patients. Exclusion criteria were active ocular disease, relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), macular pathologies, corneal decompensation or corneal endothelial cell insufficiency, irregular corneal astigmatism, pronounced dry eye disease, previous ocular trauma, or pregnancy or lactation. The local ethics board approved the study protocol (EK24-075-0624) and all patients provided written informed consent. The study adhered to the tenets of the Declaration of Helsinki and was registered at clinicaltrials.gov (NCT06607848).
INTRAOCULAR LENSES
The AN6V (Teleon Surgical) is a hydrophobic acrylic, biconvex-shaped, foldable single-piece IOL with an EDF optic using a sector-shaped aspherical surface. The overall diameter is 12.50 mm, with C-loop haptics, and an optical zone of 6.00 mm, and has a blue-light filter added. The addition for intermediate vision is +1.50 D. A toric version is also available.
The DEN00V (Johnson & Johnson) is a biconvex, hydrophobic acrylic, one-piece, foldable, posterior-chamber IOL with an overall diameter of 13.00 mm and an optic diameter of 6.0 mm. It is intended to provide a continuous range of vision from far to intermediate by using an aspherical wavefront-designed anterior and refractive posterior surface. The acrylic material includes UVAM (a supplemental UV light-absorbing material) and a proprietary violet light–filtering chromophore that reduces transmittance of violet-light wavelengths. The IOL also comes in toric powers.
Patients with regular corneal astigmatism higher than 1.0 D received a toric intraocular lens (TIOL). Participants were randomly assigned to receive the DEN00V in one eye and the AN6V into the contralateral eye.
PREOPERATIVE EVALUATION
Baseline measurements were performed in a standardized way and took place 1 week before surgery; they included refraction, visual acuity testing, and tonometry. Patients were randomized with an online randomization tool ( www.randomizer.org , list randomizer) to receive one IOL in one eye and the other IOL in the fellow eye. Patients and examining doctors were masked to the randomization throughout the entire study. To choose the right IOL power to achieve emmetropia, biometry was performed in miosis with the IOLMaster 700 (Carl Zeiss Meditec AG), and the Barrett Universal II TK formula was used. Regularity and amount of corneal astigmatism was assessed by using the MS-39 (CSO). Posterior segment optical coherence tomography imaging was performed with the Spectralis (Heidelberg Engineering GmbH) to exclude retinopathies.
SURGICAL TECHNIQUE
Surgery was routinely performed by 3 experienced surgeons with topical anesthesia, with a temporal incision of 2.4 mm, capsulorhexis, phacoemulsification, and intracapsular IOL implantation. The first operated eye received the randomly assigned IOL, followed 1 week later by implantation of the other IOL in the fellow eye. Postoperatively, all patients received standard medication consisting of bromfenac drops (Yellox; Croma Pharma and Bausch&Lomb) twice a day for 4 weeks and lubricating gel (Sicca Forte; Agepha Pharma) 1 to 3 times a day for the first week.
POSTOPERATIVE EVALUATION
Follow-up visits took place at approximately 1 week (first follow-up) and approximately 3 months (last follow-up) after cataract surgery, with assessment of monocular outcomes for uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) at 4 m (with addition of–0.25 D to adjust for infinity ); uncorrected intermediate visual acuity (UIVA) and distance-corrected intermediate visual acuity (DCIVA) at 66 cm; and uncorrected near visual acuity (UNVA) and distance-corrected near visual acuity (DCNVA) at 40 cm expressed in logMAR. Acuity was assessed using backlit Early Treatment Diabetic Retinopathy Study (ETDRS) charts (Precision Vision).
At the last follow-up visit, defocus curve measurements under photopic conditions between +1.0 D to–4.0 D in 0.5 D increments were performed, and Visual Analogue Scale (VAS) and Monocular Vision Questionnaires (MVQ) were answered. The questionnaires were handed out to the patients preoperatively to self-assess in daily activities and then performed under supervision at the last follow-up visit in the study department. In the VAS, to determine the subjective intensity of halos, the examiner first showed the participant an example image of a halo. The patient then was asked to look at a LED-glare source positioned at 2 meters distance. The patient rated the intensity of the halos on a visual analogue scale, with a score ranging from 0 (no halo) to 10 (highest intensity of halo). Furthermore, in a comparable approach, subjective visual disturbance such as starburst and glare, was assessed. In a next step, the LED-glare source was positioned at 4 meters (for far distance), 66 cm (for intermediate distance), and 40 cm (for near distance). The patient was then asked to rate the visual disturbances for each distance using a Visual Analogue Scale ranging from 0 (no visual disturbance) to 10 (strongest visual disturbance). In the MVQ, participants had to indicate whether a difference was perceptible and, if so, which group was preferred in different daily activities. In the questionnaires, each eye was alternately occluded to facilitate the most accurate comparison of the subjective visual impression. Therefore, both tests were performed monocularly. This procedure constitutes a notable strength of the assessment, as it allows for a direct side-by-side evaluation of monocular visual performance. Furthermore, contrast sensitivity under mesopic and photopic conditions, with and without glare, was investigated using the Optec 6500 Vision Tester (Stereo Optical). To evaluate halo perception, the Aston halometer was used.
SAMPLE SIZE AND STATISTICAL ANALYSES
Sample size calculation led to an inclusion required sample size of 80 eyes of 40 patients in this study for a prospective intraindividual comparison. The results of the study by Lee et al. were used, which compared an enhanced monofocal IOL and an EDF IOL. The mean uncorrected intermediate visual acuity (UIVA) for the advanced monofocal IOL was 0.16 ± 0.12 logMAR and 0.19 ± 0.17 logMAR for the EDF IOL at the 3-month follow-up visit. With G*Power, an effect size of 0.6 was calculated, which resulted in a sample size of 33 patients when a Wilcoxon signed-rank test (matched pairs) with an alpha of 0.05 and 90% power was used. To compensate for a 20% dropout rate, a total of 40 patients were needed.
Statistical analysis was performed using Excel, version 16.97 (Microsoft Corporation), and SPSS Statistics, version 30.0 (IBM Corporation). Qualitative variables were summarized as frequencies and percentages, whereas descriptive statistics were calculated for quantitative variables and are presented as mean, standard deviation, minimum, maximum, median, and interquartile range (IQR) when applicable. Comparison between the 2 eyes have been done using a paired t test in case of normally distributed data or a Wilcoxon signed-rank test in non–normally distributed data. Normality of data distribution was assessed using the Shapiro–Wilk test. An alpha level of 0.05 was considered statistically significant. The primary endpoint of the study was the difference in UIVA at 66 cm. All other outcomes were considered secondary endpoints, and P values were adjusted for multiple comparison using the Holm–Bonferroni method.
RESULTS
In total, 40 patients (80 eyes) were enrolled in this study. Three participants were lost to follow-up. The demographic baseline characteristics are presented in Table 1 . A total of 37 patients (74 eyes) were randomly assigned to receive the DEN00V in one eye and the AN6V in the contralateral eye. Baseline characteristics are presented in Table 1 . There were no significant imbalances between the groups, representing a normal cataract population.
TABLE 1
Baseline Characteristics of Study Patients.
| DEN00V | AN6V | P Value | |
|---|---|---|---|
| Age, y |
71 ± 11 y (43; 86)
26 female/11 male (70%/30%) |
||
| Sex | |||
| Axial length, mm | 23.49 ± 1.21 (20.97; 27.04) | 23.41 ± 1.16 (20.66; 26.91) | .08 |
| Anterior chamber depth, mm | 3.10 ± 0.47 (2.03; 3.94) | 3.10 ± 0.45 (2.03; 3.95) | .86 |
| Keratometric astigmatism, D | 1.04 ± 0.64 (0.17; 2.93) | 0.90 ± 0.50 (0.17; 2.04) | .16 |
| CDVA, logMAR | 0.20 ± 0.20 (–0.08; 0.82)/0.00 (0.10) | 0.20 ± 0.21 (–0.10; 0.70)/0.00 (0.12) | .80 |
| Mesopic pupil diameter, mm | 4.09 ± 0.86 (2.30; 5.85) | 4.04 ± 0.84 (2.31; 5.39) | .94 |
| Photopic pupil diameter, mm | 3.28 ± 0.73 (1.99; 4.78) | 3.16 ± 0.69 (1.90; 4.53) | .37 |
| Corneal higher-order aberration 5 mm, µm | 0.29 ± 0.08 (0.14; 0.41) | 0.31 ± 0.07 (0.14; 0.44) | .13 |
| Corneal RMS/A 5 mm, µm/mm 2 | 0.03 ± 0.01 (0.02; 0.04)/0.03 (0.02) | 0.03 ± 0.01 (0.02; 0.04)/0.03 (0.02) | .78 |
CDVA = corrected distance visual acuity; D = diopter; RMS = root mean square per area.
VISUAL ACUITY AND REFRACTIVE OUTCOMES
Refractive outcomes showed a statistically significant difference in the spherical equivalent (SE) at the last follow-up visit. The DEN00V showed a more emmetropic refraction of–0.02 ± 0.33 D (–0.75 to 0.63) compared to the AN6V of–0.33 ± 0.39 D (–1.00 to 0.50) at the last follow-up visit. The predicted SE showed a statistically significant difference between the groups, aiming for a more myopic outcome for the first group at–0.30 ± 0.12 D (–0.46 to–0.06) in comparison to–0.25 ± 0.10 D (–0.50 to–0.08). This led to a significant difference in prediction error (PE) in a positive direction for the DEN00V group of 0.32 ± 0.35 D (–0.69 to 0.86) and essentially zero for the AN6V with–0.07 ± 0.38 D (–0.79 to 0.74) ( Table 2 ).
TABLE 2
Visual Performance Parameters, Presented in Diopters.
| 3 Months | DEN00V | AN6V | P Value |
|---|---|---|---|
| SE, D | –0.02 ± 0.33 (–0.75; 0.63) | –0.33 ± 0.39 (–1.00; 0.50) | <.001* |
| Predicted SE, D | –0.30 ± 0.12 (–0.46;–0.06) | –0.25 ± 0.10 (–0.50;–0.08) | .031* |
| IOL power, D | 21.84 ± 3.27 (13.00; 27.00) | 22.00 ± 3.31 (13.50; 28.50) | .29 |
| IOL cylinder, D | 1.88 ± 0.97 (1.00; 4.50) | 1.58 ± 0.61 (0.75; 3.00) | .95 |
| PE, D | 0.32 ± 0.35 (–0.69; 0.86) | –0.07 ± 0.38 (–0.79; 0.74) | <.001* |
| PE MAE, D | 0.42 ± 0.22 (0.04; 0.86) | 0.32 ± 0.22 (0.02; 0.79) | .63 |
D = diopter; IOL = intraocular lens; MAE = mean absolute error; PE = prediction error; SE = spherical equivalent.
Testing for significance used paired t test. Barrett formula was used. Nominal statistical significance ( P <.05) is indicated by an asterisk (*). Data are presented as mean ± SD.
A statistically significant difference was observed for the primary endpoint UIVA ( P =.02), favoring the AN6V. Differences in CDVA and UNVA were nominal and did not remain statistically significant after adjustment for multiple comparisons ( Table 3 ).
TABLE 3
Visual Acuity for Far (4 m), Intermediate (66 cm), and Near (40 cm) Distance.
| 3 Months | DEN00V | AN6V | P Value |
|---|---|---|---|
| UDVA, 4 m | 0.05 ± 0.10 (–0.14; 0.32)/0.04 (0.10) | 0.06 ± 0.10 (–0.16; 0.34)/0.04 (0.12) | .53 |
| CDVA, 4 m | 0.01 ± 0.07 (–0.18; 0.18)/0.02 (0.08) | –0.02 ± 0.07 (–0.18; 0.14)/0.00 (0.10) | .01 |
| UIVA, 66 cm | 0.18 ± 0.13 (–0.08; 0.54)/0.14 (0.14) | 0.12 ± 0.09 (–0.04; 0.34)/0.12 (0.16) | .02* |
| DIVA, 66 cm | 0.17 ± 0.11 (–0.08; 0.44)/0.14 (0.10) | 0.15 ± 0.10 (0.00; 0.46)/0.12 (0.18) | .35 |
| UNVA, 40 cm | 0.32 ± 0.12 (0.10; 0.58)/0.30 (0.14) | 0.25 ± 0.10 (0.06; 0.44)/0.22 (0.12) | .01 |
| DNVA, 40 cm | 0.31 ± 0.11 (0.10; 0.58)/0.32 (0.12) | 0.32 ± 0.11 (0.04; 0.58)/0.30(0.18) | .78 |
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