The Symfony Optiblue and Vivity EDOF lenses demonstrated similar clinical performance in mesopic conditions, with the Symfony lens providing slightly better VA, and a higher likelihood of halos and starbursts.
Abstract
Purpose:
To evaluate outcomes after implantation of 2 extended depth-of-focus intraocular lenses (IOLs), with emphasis on performance in dim light.
Setting:
2 clinical practices in the United States.
Design:
Prospective, double-masked, randomized clinical trial.
Methods:
Participants were randomized to receive Symfony Optiblue or Vivity IOLs. Objective optical quality, aberrations, and simulated visual disturbances were measured before and 3 months postoperatively. Binocular visual acuity (VA), the defocus curve, and low contrast VA were measured under mesopic lighting conditions. Patient questionnaires were administered, and undirected patient comments were recorded.
Results:
31 participants in each group completed the study. Refractive outcomes were not significantly different. The Symfony lens provided about a half line better monocular mesopic VA at distance when uncorrected and best corrected (P < .05). There were no differences in binocular visual function between lenses except for the mesopic defocus curve at −1.00 diopters (D) and −1.50 D, with the Symfony lens providing better VA at those vergences (P < .02). Objective optical measures improved after surgery, with improvements not different by group. There were no differences in the size or intensity of simulated glare, but simulated halos and starburst size and intensity were significantly worse with the Symfony lens (P < .05). Satisfaction with distance and intermediate vision in both groups was high. Reported visual disturbances were not significantly different between groups.
Conclusions:
The 2 lenses provided similar visual performance in dim light, with the Symfony lens showing slightly better VA, but with more reports of halos and starbursts.
Modern intraocular lenses (IOLs) can correct astigmatism, mitigate presbyopia, or both. Presbyopia correcting IOLs provide an increased range of vision, with higher ranges of vision generally correlated with a higher likelihood of photic phenomena such as glare and/or halos.1–3 An increased range of vision may be achieved by incorporating spherical aberration, diffraction, or other optical elements.4 If a specific set of criteria related to improved intermediate vision is met, the IOL in question may be categorized as an extended depth-of-focus (EDOF) IOL (ANSI Z80.35-2018).5
The Tecnis Symfony IOL (Johnson & Johnson Vision) uses a proprietary achromatic diffractive echelette design across the anterior surface of the lens optic, correcting chromatic aberration to enhance contrast sensitivity. Results demonstrate better intermediate and near vision than a monofocal IOL, with similar contrast sensitivity, higher levels of spectacle independence, and only slight increases in the incidence of halos and starbursts.6,7 Bench testing suggests that the addition of the Optiblue violet light-filtering chromophore will provide improved contrast sensitivity and mitigation of dysphotopsias.8
In a different approach, the Clareon Vivity IOL (Alcon Laboratories, Inc.) incorporates a proprietary technology comprised of a central plateau (∼1 mm in diameter) overlaid on a 2.2 mm central optic on the anterior surface to alter the incoming wavefront, creating an EDOF effect without the use of diffractive elements.9 Clinical results show that the lens provides improved intermediate and near vision relative to a monofocal IOL, with a similar visual disturbance profile.10,11
Bench testing confirms the EDOF properties of the 2 lenses, but their ray propagation and light intensity profiles differ.12 However, the numerous constraints in bench testing (eg, 0.1 mm pinhole source, 4.5 mm aperture, +0.28 μm level of simulated corneal spherical aberration, and 520 nm single-wavelength laser source) reduce its clinical utility; clinical performance is affected by polychromatic light, patients' individual optical aberrations, and pupil size. The latter may be important because the Symfony EDOF design covers the entire anterior optic, while the Vivity IOL has its EDOF component incorporated into the central 2.2 mm of the anterior optic. This may result in different performance in mesopic conditions, where larger pupils are likely.
This study was designed to compare the subjective and objective outcomes associated with implantation of these 2 EDOF IOLs in patients presenting for cataract surgery, with an emphasis on performance under dim light conditions.
METHODS
This was a prospective, 2-center, double-masked (participant and evaluator), randomized study. Eligible participants were randomized to receive bilateral Symfony Optiblue IOLs or bilateral Clareon Vivity IOLs (toric or nontoric), with all eyes targeted for emmetropia. The study was approved by an institutional review board (Salus IRB, Austin, TX) and registered with ClinicalTrials.gov (record NCT 06229106). The study was conducted in a manner consistent with good clinical practice and the tenets of the Declaration of Helsinki. Data collection was HIPPA compliant, and all participants signed an appropriate informed consent document.
Participants had to be 50 years or older, scheduled for bilateral lens extraction with an EDOF lens targeted for plano in both eyes and with a potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes. Exclusion criteria included severe dry eye, previous intraocular or refractive surgery, corneal irregularities, and any ocular or systemic pathology likely to affect postoperative VA. Enrolled participants experiencing surgical complications were discontinued from the study and followed until resolution.
Preoperative testing included a manifest refraction, potential acuity testing, and a slitlamp examination with a dilated fundus examination and ocular coherence tomography. Ocular biometry was performed with the IOLMaster 700 (Carl Zeiss Meditec AG) and/or the Lenstar 900 (Haag-Streit AG), with lenses chosen using the Barrett Universal II formula. Topography was measured using the Oculus Pentacam. Toric IOL cylinder power was calculated using the Barrett Integrated K's with the Barrett Toric formula using Veracity (Carl Zeiss Meditec AG). Bilateral femtosecond laser-assisted cataract surgery was performed using the surgeon's preferred technique, implanting the EDOF lens indicated for the participant based on their assigned group.
Postoperative testing was completed 3 months after the second-eye surgery. The room luminance was checked with a light meter (Gossen Starlite 2) at the beginning of each test for both photopic and mesopic conditions. Test ranges were 85 to 100 cd/m2 for photopic testing and 3 to 5 cd/m2 for mesopic testing. Under photopic conditions, a manifest refraction was performed and the binocular corrected distance visual acuity (CDVA) was evaluated at 4 m, 66 cm, and 40 cm. In mesopic conditions, the monocular uncorrected distance visual acuity (UDVA) and CDVA were measured, along with the binocular UDVA and CDVA, intermediate (uncorrected intermediate visual acuity [UCIVA], distance corrected intermediate visual acuity), and near vision (uncorrected near visual acuity, distance corrected near visual acuity). The mesopic VA was evaluated using a neutral density filter at 1 site (CFS), with the filter placed in front of the backlit Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The other site had an ETDRS chart that allowed dimming of the chart for mesopic testing. A mesopic binocular distance corrected defocus curve was also measured, and VA was tested with low contrast (25% and 10%) letters in mesopic conditions.
Participants completed several questionnaires regarding their spectacle independence and their experience with visual disturbances. These included the Patient-Reported Spectacle Independence Questionnaire, the Patient-Reported Visual Symptom Questionnaire, and the 25-question Visual Function Questionnaire.13 Unprompted comments from participants at the final visit were also recorded.
Objective optical quality and aberrations were assessed preoperatively and postoperatively using the iTrace Visual Function Analyzer (Tracey Technologies), a device that combines ray-tracing aberrometry and Placido-based corneal topography. This system allows for differentiation between corneal and internal (lenticular or IOL-related) optical contributions and provides a simulated visual function assessment. All measurements were performed in accordance with the manufacturer's instructions. The following parameters were assessed: depth of focus, spherical equivalent, effective range of focus, angle alpha, angle kappa, and their respective axes (AA axis and AK axis). Optical quality metrics included the modulation transfer function (MTF) at 10 cycles per degree (c/d) for the internal optics, cornea, and total system, as well as the average MTF height for each. In addition, the point spread function was evaluated separately for the internal, corneal, and total optical system.
The Glare and Halo Simulator (ViSU-L GmbH), an interactive tool designed to simulate photic phenomena under controlled conditions, was used to objectively evaluate visual disturbances preoperatively and postoperatively (Figure S1, available at http://links.lww.com/JRS/B579). Although a nonvalidated test, it has the ability to separately simulate halos, starbursts, and glare in a way that could be individually adjusted and documented. Three types of symptoms were evaluated sequentially: type 1 (halos), type 2 (starburst), and glare. The size was initially set to zero and the intensity parameter to 50. For each type, the visual disturbance size was adjusted first; if a nonzero size was recorded, participants were then prompted to adjust the intensity. If size was set to zero, intensity was not assessed and retained the default system value of 50. For analysis purposes, these were interpreted as zero intensity. Each phenomenon was assessed independently. A combination of symptoms was not evaluated.
The sample size calculation was based on presuming a SD of 0.12 logMAR units in the UCIVA. With an alpha of 0.05 and a beta (power) of 0.9, a sample size of 32 participants in each group was determined to be required to reliably detect a 0.1 logMAR (1 line) difference in UCIVA using a 2-sided test.
The Statistica data analysis software system, v. 12 (TIBCO Software, Inc.), was used for all analyses. Parametric comparisons were made using analysis of variance (equivalent to a t test when only 2 groups are present), and nonparametric data were compared using the chi-squared test. All statistical tests were 2-sided with P = .05 considered significant. Significant differences, where noted, indicate a P ≤ .05.
RESULTS
A total of 64 participants (128 eyes) were successfully enrolled. One participant discontinued the study, and the other participant had cystoid macular edema postsurgery, leaving 62 participants in the analysis pool (31 participants in each group). The average age was 70 ± 6 years, ranging from 53 to 83, with no significant difference by group (P = .98). The preoperative mean refraction spherical equivalent (MRSE) was more myopic in the Symfony group (−1.46 ± 2.8 Symfony vs 0.15 ± 2.3 Vivity, P < .01), and there were more toric IOLs in the Symfony group (45% vs 27%, P = .04). Neither of these factors was expected to materially influence postoperative results.
Monocular Results
Table S1 (available at http://links.lww.com/JRS/B581) summarizes the monocular findings. There were no significant differences in the MRSE or residual refractive cylinder by group. While not shown, there was no effect of lens type (toric/nontoric) on MRSE (P = .6) or residual refractive cylinder (P = .39). The Symfony lens provided participants with about a half line better monocular mesopic visual acuity at distance (4 m) when uncorrected (P = .04) and corrected (P = .04). Testing was based on averaging the VA of both eyes per participant to account for intereye correlation.
The percentage of eyes with an MRSE within 0.50 diopters (D) of the target (plano) was not significantly different between groups (Symphony, 58/62, 93% vs Vivity 54/62, 87%, chi-squared test, P = .22). The percentage of eyes with a residual refractive cylinder ≤ 0.50 D was also not significantly different between groups (Symphony, 57/62, 92% vs Vivity 58/62, 93%, chi-squared test, P = .73).
The iTrace evaluation compared the preoperative and postoperative results by lens group, and are shown in Figure S2a-c (available at http://links.lww.com/JRS/B580). The objective depth of field was significantly lower after surgery (P < .01), but there were no significant differences between lens groups at the preoperative or postoperative visits (Figure S2a, available at http://links.lww.com/JRS/B580). Preoperative values in cataractous eyes can be overestimated, as a function of the higher-order aberrations in the eye, and the presence of significant preoperative refractive error (>1.0 D) (personal communication, iTrace staff). Figure S2b (available at http://links.lww.com/JRS/B580) shows the average total MTF value. There was no significant difference in the MTF by lens, but there was a significant improvement in the MTF after surgery (P < .01). Figure S2c (available at http://links.lww.com/JRS/B580) shows the average total point spread function. As with the MTF, results were not significantly different between lens groups, but there was a significant improvement from preoperative to postoperative (P < .01).
Binocular Results
Table 1 summarizes the binocular visual acuity results under various test conditions. The largest difference between the lenses was seen at distance (UDVA and CDVA), with the Symfony lens having a mean acuity about 2 letters better than the Vivity lens in mesopic conditions, but this was not statistically significant. There were no significant differences in the results between groups for any test conditions at any test distances. The VA measured in mesopic conditions was generally about 1.5 lines lower than that measured in photopic conditions.
Table 1.
Summary of binocular VA data (logMAR)
| Variable | Group | Mean | SD | Minimum | Maximum | P value |
| Photopic | ||||||
| CDVA (4 m) | Symfony | −0.09 | 0.11 | −0.20 | 0.40 | .31 |
| Vivity | −0.06 | 0.08 | −0.18 | 0.14 | ||
| DCIVA (66 cm) | Symfony | 0.09 | 0.10 | −0.10 | 0.30 | .19 |
| Vivity | 0.12 | 0.08 | −0.08 | 0.26 | ||
| DCNVA (40 cm) | Symfony | 0.32 | 0.14 | 0.00 | 0.58 | .49 |
| Vivity | 0.35 | 0.15 | 0.00 | 0.60 | ||
| Mesopic | ||||||
| UDVA (4 m) | Symfony | 0.11 | 0.10 | −0.14 | 0.32 | .09 |
| Vivity | 0.15 | 0.10 | 0.02 | 0.50 | ||
| CDVA (4 m) | Symfony | 0.06 | 0.07 | −0.10 | 0.22 | .08 |
| Vivity | 0.10 | 0.07 | −0.04 | 0.24 | ||
| UCIVA (66 cm) | Symfony | 0.28 | 0.20 | 0.00 | 0.94 | .72 |
| Vivity | 0.26 | 0.11 | 0.04 | 0.60 | ||
| DCIVA (66 cm) | Symfony | 0.27 | 0.17 | 0.00 | 0.98 | .19 |
| Vivity | 0.32 | 0.11 | 0.08 | 0.62 | ||
| UCNVA (40 cm) | Symfony | 0.50 | 0.17 | 0.20 | 1.08 | .60 |
| Vivity | 0.48 | 0.15 | 0.20 | 0.80 | ||
| DCNVA (40 cm) | Symfony | 0.54 | 0.15 | 0.20 | 1.12 | .73 |
| Vivity | 0.52 | 0.12 | 0.30 | 0.70 | ||
| Mesopic low contrast | ||||||
| CDVA (4 m, 25%) | Symfony | 0.23 | 0.08 | 0.00 | 0.42 | .24 |
| Vivity* | 0.25 | 0.08 | 0.12 | 0.40 | ||
| CDVA (4 m, 10%) | Symfony | 0.44 | 0.10 | 0.16 | 0.62 | .69 |
| Vivity | 0.43 | 0.10 | 0.10 | 0.58 |
aResults for 1 participant were unavailable
The distance corrected binocular defocus curve, measured in mesopic lighting conditions, is shown in Figure 1. There was a significant effect of vergence on the measured VA (P < .001), but the lens group was not a significant effect overall (P = .199). The Symfony group showed significantly better VA at vergences of −1.0 D (P = .01) and −1.5 D (P = .02). There were no other vergences at which the VA differed between lenses.
Figure 1.
Mean binocular defocus curve, mesopic conditions.
Binocular simulated glare, halos, and starbursts (size and intensity) were measured preoperatively and postoperatively, in both the uncorrected and best corrected states. One site did not record the best corrected preoperative data. As expected, there were no significant differences in the size or intensity of glare, halos, or starbursts at the preoperative visit. Results from the simulated halos, glare, and starbursts testing in the uncorrected state at both visits are shown in Figure 2, including size and intensity. A repeated measures analysis of results by lens and time was conducted for these results. Glare size (P = .52) and intensity (P = .07) were not significantly different between lens groups, but both were lower after surgery (P < .01). Similarly, halo size (P = .23) and intensity (P = .30) were not significantly different by lens but were both lower after surgery (P < .01). Starburst size (P = .02) and starburst intensity (P = .04) were significantly higher with the Symfony lens. As with glare and halos, the size and intensity of starbursts was lower after surgery but decreased more in the Vivity participants.
Figure 2.
Simulated halo, glare, and starburst size and intensity before and after surgery, by lens (vertical bars denote 0.95 CIs of the means)
Table 2 summarizes the data for the simulated size and intensity of glare, halos, and starbursts by lens at the postoperative visit, in both the corrected and uncorrected states. There was no significant difference in the size or intensity of glare by lens when tested either uncorrected or best corrected. Both the size and intensity of halos were significantly higher in the Symfony group in the uncorrected state, and the size of halos was significantly higher in the Symfony group in the corrected state. The size and intensity of starbursts were significantly higher with the Symfony lens in both the uncorrected and corrected test conditions.
Table 2.
Simulated postoperative glare, halo, and starburst size and intensity by lens and correction
| Type | Measure | Correction | Group | Mean | SD | Minimum | Maximum | P value |
| Glare | Size | Uncorrected | Symfony | 24.5 | 15.2 | 0.0 | 54.0 | .13 |
| Vivity | 18.8 | 13.6 | 0.0 | 51.0 | ||||
| Corrected | Symfony | 26.1 | 17.1 | 0.0 | 81.0 | .07* | ||
| Vivity | 18.7 | 14.0 | 0.0 | 53.0 | ||||
| Intensity | Uncorrected | Symfony | 33.0 | 18.1 | 0.0 | 61.0 | .09 | |
| Vivity | 25.4 | 17.0 | 0.0 | 57.0 | ||||
| Corrected | Symfony | 31.4 | 17.9 | 0.0 | 61.0 | .46 | ||
| Vivity | 27.9 | 18.8 | 0.0 | 70.0 | ||||
| Halos | Size | Uncorrected | Symfony | 30.0 | 20.8 | 0.0 | 70.0 | <.01* |
| Vivity | 16.2 | 10.4 | 0.0 | 34.0 | ||||
| Corrected | Symfony | 32.1 | 19.4 | 0.0 | 79.0 | <.01* | ||
| Vivity | 19.0 | 10.9 | 0.0 | 40.0 | ||||
| Intensity | Uncorrected | Symfony | 37.9 | 18.8 | 0.0 | 64.0 | .02* | |
| Vivity | 27.5 | 15.6 | 0.0 | 50.0 | ||||
| Corrected | Symfony | 36.6 | 17.8 | 0.0 | 64.0 | .19 | ||
| Vivity | 30.8 | 17.3 | 0.0 | 76.0 | ||||
| Starbursts | Size | Uncorrected | Symfony | 46.9 | 20.7 | 9.0 | 99.0 | <.01* |
| Vivity | 25.2 | 19.0 | 0.0 | 77.0 | ||||
| Corrected | Symfony | 47.8 | 22.2 | 8.0 | 100.0 | <.01* | ||
| Vivity | 23.0 | 16.4 | 0.0 | 77.0 | ||||
| Intensity | Uncorrected | Symfony | 45.5 | 17.9 | 13.0 | 100.0 | <.01* | |
| Vivity | 28.7 | 16.1 | 0.0 | 70.0 | ||||
| Corrected | Symfony | 44.1 | 21.0 | 6.0 | 100.0 | .04* | ||
| Vivity | 33.9 | 16.8 | 0.0 | 70.0 |
*indicates statistically significant (< 0.05).
The results from the Patient-Reported Spectacle Independence Questionnaire are summarized in Table 3. There were no significant differences in the responses to any of the questions. In both groups, there was a high level of spectacle independence for viewing at distance and intermediate, and high satisfaction with vision at those distances. Overall, 31% of participants (19/62) indicated they did not need spectacles for reading. Fifty-four percent of participants in both groups (33/61) indicated that they were completely or mostly satisfied with their uncorrected near vision.
Table 3.
PRSIQ results summary
| Measure | Category | Group | No | Yes | No (%) | P valuea | |||
| Need for spectacles | Distance | Symfony | 31 | 100 | 1.00 | ||||
| Vivity | 31 | 100 | |||||||
| Intermediate | Symfony | 31 | 100 | .08 | |||||
| Vivity | 28 | 3 | 90 | ||||||
| Near | Symfony | 7 | 24 | 23 | .17 | ||||
| Vivity | 12 | 19 | 39 |
| Category | Group | All | Most | Some | A little | None | None/a little (%) | P value | |
| Strain to see without spectacles (time) | Overall | Symfony | 1 | 2 | 4 | 9 | 15 | 77 | 0.18 |
| Vivity* | 3 | 9 | 18 | 90 | |||||
| Distance | Symfony | 31 | 100 | 1.00 | |||||
| Vivity | 3 | 28 | 100 | ||||||
| Intermediate | Symfony | 2 | 29 | 94 | .64 | ||||
| Vivity | 1 | 2 | 4 | 24 | 90 | ||||
| Near | Symfony | 7 | 4 | 5 | 7 | 8 | 48 | 1.00 | |
| Vivity | 5 | 4 | 7 | 4 | 11 | 48 | |||
| Time wearing spectacles | Overall | Symfony | 1 | 3 | 4 | 8 | 15 | 74 | .54 |
| Vivity | 1 | 5 | 7 | 18 | 81 | ||||
| Distance | Symfony | 1 | 1 | 29 | 94 | .15 | |||
| Vivity | 1 | 30 | 100 | ||||||
| Intermediate | Symfony | 1 | 1 | 1 | 1 | 27 | 90 | 1.00 | |
| Vivity | 3 | 1 | 27 | 90 | |||||
| Near | Symfony | 10 | 5 | 5 | 4 | 7 | 35 | .44 | |
| Vivity | 7 | 7 | 3 | 2 | 12 | 45 |
| Category | Group | Completely | Mostly | Moderately | A little | Not at all | Completely/mostly (%) | P value | |
| Satisfaction with uncorrected vision | Overall | Symfony | 14 | 11 | 3 | 3 | 81 | .52 | |
| Vivityb | 11 | 15 | 3 | 1 | 87 | ||||
| Distance | Symfony | 25 | 4 | 1 | 1 | 94 | .57 | ||
| Vivityb | 25 | 4 | 1 | 97 | |||||
| Intermediate | Symfony | 21 | 7 | 2 | 1 | 90 | .32 | ||
| Vivityb | 22 | 7 | 1 | 97 | |||||
| Near | Symfony | 9 | 5 | 4 | 4 | 9 | 45 | .15 | |
| Vivityb | 8 | 11 | 5 | 2 | 4 | 63 |
PRVSQ = Patient-Reported Spectacle Independence Questionnaire
P values based on the chi-squared test, * indicates statistically significant (< 0.05)
Responses from 1 participant were unavailable
Results from the Patient-Reported Visual Symptom Questionnaire are summarized in Table 4. While reported, Occlusions and Double Vision are not included in the table because of space constraints because few participants reported them, and none were more than slightly bothered or had any reported difficulty. One participant in the Vivity group did not complete the questionnaire. The frequency of halos and starbursts was significantly higher in the Symfony group, as was the degree of bother associated with halos. There were no other significant differences in the frequency or degree of bother for the visual disturbances reported. Despite the differences noted above, the difficulty participants reported from all visual disturbances was not significantly different between groups.
Table 4.
PRVSQ results summary (Vivity n = 30, Symfony n = 31)
| Measure | Type | Group | Total | Never | Rarely | Sometimes | Often | Always | Never/rarely (%) | P valuea |
| Frequency of disturbances | Halos | Symfony | 31 | 11 | 6 | 3 | 4 | 7 | 55 | .03* |
| Vivity | 30 | 20 | 5 | 5 | 83 | |||||
| Glare | Symfony | 31 | 19 | 7 | 4 | 1 | 84 | 1.00 | ||
| Vivity | 30 | 24 | 2 | 4 | 87 | |||||
| Starbursts | Symfony | 31 | 10 | 5 | 4 | 7 | 5 | 48 | .002* | |
| Vivity | 30 | 20 | 6 | 2 | 1 | 1 | 87 | |||
| Poor vision in low light | Symfony | 31 | 17 | 5 | 8 | 1 | 71 | .79 | ||
| Vivity | 30 | 15 | 5 | 3 | 5 | 2 | 67 | |||
| Light sensitivity | Symfony | 31 | 10 | 8 | 8 | 5 | 58 | .61 | ||
| Vivity | 30 | 13 | 2 | 9 | 5 | 1 | 50 |
| Type | Group | Total | Not at all | Slightly | Moderately | Very | Extremely | Not at all/slightly (%) | P value | |
| Degree of bother | Halos | Symfony | 31 | 17 | 8 | 5 | 1 | 81 | .02* | |
| Vivity | 30 | 25 | 5 | 100 | ||||||
| Glare | Symfony | 31 | 23 | 5 | 2 | 1 | 90 | .61 | ||
| Vivity | 30 | 25 | 4 | 1 | 97 | |||||
| Starbursts | Symfony | 31 | 15 | 11 | 3 | 2 | 84 | .19 | ||
| Vivity | 30 | 24 | 5 | 1 | 97 | |||||
| Poor vision in low light | Symfony | 31 | 19 | 11 | 1 | 97 | .053 | |||
| Vivity | 30 | 19 | 5 | 4 | 2 | 80 | ||||
| Light sensitivity | Symfony | 31 | 13 | 10 | 6 | 2 | 74 | 1.00 | ||
| Vivity | 30 | 13 | 10 | 3 | 3 | 1 | 77 |
| Type | Group | Total | No | Yes | “No” (%) | P value | ||||
| Reported difficulty | Halos | Symfony | 31 | 30 | 1 | 97 | 1.00 | |||
| Vivity | 30 | 30 | 100 | |||||||
| Glare | Symfony | 31 | 31 | 100 | .11 | |||||
| Vivity | 30 | 27 | 3 | 90 | ||||||
| Starbursts | Symfony | 31 | 30 | 1 | 97 | 1.00 | ||||
| Vivity | 30 | 30 | 100 | |||||||
| Poor vision in low light | Symfony | 31 | 30 | 1 | 97 | .35 | ||||
| Vivity | 30 | 27 | 3 | 90 | ||||||
| Light sensitivity | Symfony | 31 | 29 | 2 | 94 | .67 | ||||
| Vivity | 30 | 27 | 3 | 90 |
PRVSQ = Patient-Reported Visual Symptom Questionnaire
P values based on the chi-squared test, * indicates statistically significant (< 0.05)
The 25-question Visual Function Questionnaire was administered to collect responses related to driving at night, driving in difficult conditions, and negotiating stairs or curbs in dim light. There were no significant differences in the responses to these questions by group (P > .42 in all cases). More than 90% of participants in both groups reported no difficulty or only a little difficulty with these tasks.
Participants in the study were also asked nondirected questions about symptoms or concerns. A total of 28 nondirected comments were provided, 15 from Symfony participants and 13 from Vivity participants. Twelve of these (5 Symfony, 7 Vivity) were related to difficulty reading. Four participants spontaneously reported issues with halos, starbursts, or glare. All of these were in the Symfony group. Five participants (2 Symfony, 3 Vivity) commented on filmy or blurry vision. One Vivity participant noted decreased vision in low light. The remaining 6 comments were not related to lenses or vision.
There were 9 reported adverse events (AEs) during the study, one of which was not eye related. The remaining 8 were (1) 2 bilateral cases of cystoid macular edema (1 Vivity and 1 Symfony), (2) 1 bilateral case of lens-induced uveitis (Symfony), (3) 2 cases of vitreomacular adhesion (both eyes of 1 patient, Symfony), (4) 1 microaneurysm (Vivity), and (5) 1 small capsular tear at the time of surgery, with later slight dislocation of the IOL (Vivity). Only 1 of these (uveitis) was related to the lens implanted. Treating bilateral cases as 2 separate AEs (by eye), there was no significant difference in the rate of AEs by lens group, either considering all cases (Fisher exact test, P = 1.0) or just the 2 lens-related cases (Fisher exact test, P = .49).
DISCUSSION
The results from this study of the performance of 2 EDOF lenses with different optical designs suggest that they are equally effective for providing good distance and intermediate vision in dim light conditions. The 1.5 line decrease in binocular CDVA in mesopic conditions measured for the Symfony lens was consistent with results reported by Schojai et al.14 As expected for both lenses, near vision was not as good, and this was noted by participants.
The primary objective of this study was to evaluate visual function in dim light. The Symfony IOL seemed to provide slightly better VA, based on the monocular mesopic VA testing and the binocular mesopic defocus curve. The relatively lower intermediate VA with the Vivity IOL may be a function of the larger pupil size, which, based on its design, would cause relatively less light to be channeled to near/intermediate foci.
The apparent tradeoff for slightly improved visual acuity in dim light was that the Symfony IOL was associated with significantly more halos and starbursts, relative to the Vivity IOL. This latter observation seems consistent with the expectations from bench testing conducted by Baur et al., where diffractive elements were associated with a greater likelihood of halos.13 There were no differences between the 2 lenses about any other clinical measure of mesopic visual function.
Qualitatively, the lenses seemed to be nearly equivalent in their performance. Although differences in visual disturbances were noted, the difficulty associated with these visual disturbances was not significantly different between lenses. Satisfaction rates for both lenses were also not significantly different, nor were the rates of spectacle independence for far, intermediate, or near vision. There were also no differences between lenses regarding driving at night, driving in difficult conditions, or navigating stairs or curbs in dim light.
There are several limitations to this study. Sample size was estimated based on photopic VA because there was no reliable mesopic VA data available for the purpose. This may have underestimated the necessary sample size to show differences. However, most of the comparisons did not yield marginal P values (eg, 0.06 to 0.10), so we do not believe this was a significant limiting factor. The methodology for testing mesopic vision was slightly different by site, but both lenses were implanted at both sites, so the relative effect of this was expected to be minimal. The use of the Glare and Halo Simulator presents both advantages and limitations. Although it allowed us to simulate and document specific photic phenomena in a controlled, patient-adjustable format, the tool is not a validated standard such as straylight measurement. We acknowledge that the simulation of halos and starbursts as separate from glare, and the use of independent “size” and “intensity” sliders, may oversimplify phenomena that are intrinsically linked in human perception. Furthermore, the system's visual rendering may cause changes in perceived shape based on screen distance, which does not replicate real-world optics and introduces a degree of artificiality. Some participants reported a size of zero, which may reflect an inability to distinguish the simulation from their baseline perception or from test-induced light scatter. Nonetheless, we included this simulator to complement traditional measures by capturing objective aspects of postoperative visual quality in a reproducible, interactive way. In addition, although additional biometric measures were available from some diagnostic instruments (eg, pupil size, angle alpha, and angle kappa), no formal analysis of these variables was performed.
We believe these results are important, as the first of their kind to be reported. Our efforts have shown us that there are opportunities to better understand IOL performance in dim light. In particular, collecting pupil size data in both photopic and mesopic conditions at all relevant test distances would be very helpful because it would make it possible to analyze visual acuity and visual disturbance outcomes as a function of pupil size under each specific test condition. A single-pupil size measurement is inadequate for this purpose.
WHAT WAS KNOWN
EDOF lenses provide good distance and intermediate vision in photopic conditions.
Different EDOF optical design principles may affect vision in different ways, based on pupil size and other considerations.
WHAT THIS PAPER ADDS
This is the first report, to the our knowledge, of EDOF lens performance in mesopic conditions.
The 2 EDOF lenses here exhibited similar overall clinical performance, with slightly better VA with 1 EDOF lens, but with an associated increase in halos and starbursts.
Footnotes
The study was supported by an investigator-initiated study grant from Johnson and Johnson Vision, Santa Ana, California.
Presented at the 42nd Congress of the ESCRS, Barcelona, Spain, September 2024, and the 2025 ASCRS Annual Meeting in Los Angeles, California, April 2025.
Disclosures: J. De Rojas is a consultant for Johnson & Johnson Vision, LENSAR, Inc., Carl Zeiss Meditec AG, Sun Pharmaceuticals, Nordic Pharmaceuticals, Abbvie, and Rxsight, Inc. R. Potvin is a consultant to Alcon Laboratories, Inc. and Hoya Corp. K.D. Solomon is a consultant for Alcon Laboratories, Inc., AVTR MED, CVC Capital Partners, Glaukos Corp., Mati Therapeutics, Rayner Intraocular Lenses Ltd., Rxsight, Inc., STAAR Surgical Co., and Zhaoke Pharmaceuticals. H.P. Sandoval has no financial or proprietary interest in any material or method mentioned.
First author:
Joaquin O. De Rojas, MD
Center For Sight/US Eye, Sarasota, Florida
Contributor Information
Helga P. Sandoval, Email: helga.sandoval@carolinaeyecare.com.
Kerry D. Solomon, Email: Kerry.Solomon@USEye.com.
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