One-year prospective study of a HEMA-based hydrophobic acrylic trifocal IOL (Clareon PanOptix): visual performance, patient-reported outcomes, and optic clarity

Abstract

While Clareon monofocal intraocular lens (IOL) has been reported to be free from surface light scattering and glistenings, it remains unknown whether Clareon PanOptix IOL develops these optical phenomena. This study aimed to evaluate one-year surgical outcomes of this IOL, with a focus on visual function, patient-reported satisfaction, and clarity of IOL optics. A prospective study was conducted in 78 eyes of 39 patients undergoing bilateral implantation of toric or non-toric Clareon PanOptix IOLs. Postoperative examinations were conducted at 1, 6, and 12 months. At 12 months, bilateral uncorrected visual acuity (BUCVA) and bilateral distance-corrected visual acuity (BDCVA) were better than 20/20 at 40 cm, 60 cm, and 5 m. No cases of surface light scattering or glistenings were observed. Spectacle independence was achieved in 84.2% of patients. While patient satisfaction with vision in daily life and daytime driving was high, approximately half of the patients reported some difficulty with night driving. The Clareon PanOptix provided satisfactory surgical outcomes, with no formation of surface light scattering or glistenings during the one-year follow-up period.

Supplementary Information

The online version contains supplementary material available at 10.1038/s41598-026-35603-5.

Both surface light scattering^1,2 and glistenings^3,4 are unwanted optical phenomena associated with intraocular lenses (IOLs), particularly those made from hydrophobic acrylic materials, such as AcrySof IOLs (Alcon Laboratories, Inc., Fort Worth, TX)⁵. These phenomena can lead to visual disturbances due to increased straylight and glare, potentially necessitating IOL exchange surgery in severe cases^6–9. To mitigate these issues, newer IOL models have been developed with enhanced materials and manufacturing processes.

The Clareon CNA0T0 IOL (Alcon Laboratories, Inc., Fort Worth, TX) features a higher water content of 1.5% and is designed to minimize or eliminate surface light scattering and glistenings, thereby improving optical clarity. In addition, advances in manufacturing processes, including better environmental controls and packaging methods, have contributed to a reduction in the occurrence of these phenomena. Clinical studies have demonstrated that Clareon monofocal IOLs remained free from surface light scattering and glistenings over a period of 1 to 9 years following implantation^10–17.

The technology used in Clareon monofocal IOLs has been incorporated into the development of Clareon PanOptix trifocal IOLs. While several studies have reported short-term outcomes (1 to 6 months) for this multifocal IOL^18–22, long-term data are unavailable. In particular, there is a lack of research on the development of surface light scattering and glistenings in the Clareon trifocal IOL. Given that recipients of multifocal IOLs may be more sensitive to optical disturbances such as increased light scattering, enhanced stray light, and reduced transparency, this area requires further in-depth investigation.

This prospective one-year study aimed to evaluate the surgical outcomes of bilateral implantation of Clareon PanOptix IOL, focusing on visual function, patient-reported satisfaction, and clarity of IOL optics.

Methods

Patient recruitment

This study was a single-arm, multicenter trial conducted at three surgical sites in Japan. Participants were selected from consecutive cases of patients eligible for bilateral surgery for age-related cataracts between December 2022 and November 2023. Exclusion criteria included a history of prior ocular surgery or any ocular pathology that could potentially affect surgical outcomes. Patients under 20 years of age were also excluded.

This study adhered to the principles of the Declaration of Helsinki and was conducted in accordance with the Ministerial Ordinance on Standards for Post Marketing Investigation and Studies of Medical Devices (Ministerial Ordinance of the Ministry of Health, Labour and Welfare No. 38 of 2005) and the Ethical Guidelines for Medical and Health Research Involving Human Subjects (Ministry Notification of MEXT and MHLW No. 3 of 2014). The study protocol was reviewed and approved by the Non-Profit Organization MINS Institutional Review Board in Tokyo (JCS# 75506435) on October 17, 2022. Written informed consent was obtained from each patient prior to enrollment. Patient enrollment commenced on November 3, 2022, and the final trial record was made publicly available on the UMIN Clinical Trials Registry (UMIN-CTR) on June 1, 2025 (UMIN000058036, R000066336).

Intraocular lens and surgery

The Clareon PanOptix is a single-piece hydrophobic acrylic diffractive trifocal IOL. Its material composition substitutes hydroxyethyl methacrylate (HEMA) for phenylethyl methacrylate, as found in AcrySof IOLs, resulting in a water content of 1.5% at 35 °C and a glass transition temperature of 9.1 °C. The IOL incorporates blue-light-blocking properties and features an aspheric optic design with a 6 mm diameter and a sharp-edged posterior surface. Its refractive index is 1.55 at 35 °C. The diffractive optics, spanning a 4.5 mm diameter on the anterior surface, provide add powers of 2.17 diopter (D) and 3.25 D.

Cataract surgeries were performed by a single experienced surgeon at each site. The procedures involved phacoemulsification and aspiration techniques to remove cataracts through 2.2–2.4 mm temporal corneal incisions. The IOLs were implanted in the capsular bag using the designated AutonoMe injectors. IOL power was determined for emmetropia using standard biometry and power calculation formulas applied at each site. Depending on the amount of preoperative corneal astigmatism, either Clareon PanOptix non-toric IOL (CNWTT0) or toric IOL (CNWTT2-TT6) was implanted. For toric IOL axis alignment, digital navigation systems were employed, including either the VERION Image Guided System (Alcon Laboratories, Inc., Fort Worth, TX) or the CALLISTO eye system (Carl Zeiss Meditec AG, Jena, Germany).

Examinations

Postoperative assessments were conducted at 1, 6, and 12 months following surgery. These evaluations included measurements of monocular and binocular visual acuities, and manifest refraction spherical equivalent (MRSE). Monocular and binocular uncorrected (UCVA and BUCVA, respectively) and distance-corrected (DCVA and BDCVA, respectively) visual acuities were assessed at distances of 40 cm, 60 cm, and 5 m using an all-distance Landolt C chart (System Chart SC-1600, Nidek Co., Ltd., Gamagori, Japan). Measurements were performed under photopic conditions (500 lx at the corneal plane, verified with a Konica Minolta T-10 A lux meter) with natural, undilated pupils. MRSE was also measured during the DCVA assessments at 5 m. Visual acuity values were converted to logMAR for subsequent analyses.

At each postoperative visit, the occurrence of adverse events related to surgery or IOL was documented. Under pupil dilation, the degree of glistenings in the IOL optic was evaluated using a four-point scale (0–3) based on the Miyata grading system²³. Additionally, the presence of surface light scattering was carefully assessed using a slit-lamp microscope under full pupil dilatation.

Patients were asked to rate the difficulty associated with various daily visual tasks using a questionnaire with a five-point scale: not difficult, occasionally difficult, sometimes difficult, difficult, and very difficult. Additionally, the questionnaire assessed difficulties during driving using a four-point scale: not difficult, occasionally difficult, sometimes difficult, and very difficult (Supplemental table). At one surgical site, sixteen patients evaluated the degree of glare, halo, and starburst using a four-point scale: none, mild, moderate, and severe, at 1 and 12 months postoperatively.

Binocular visual acuity and optical clarity at 12 months postoperatively were designated as the primary outcomes. A pre-study power analysis, employing a two-sided significance level of 5% (α) and a statistical power of 80% (1-β), indicated that a sample size of 35 eyes would be necessary to detect a clinically and statistically significant reduction in the severity of glistening and surface light scattering. This calculation was based on the reported incidence and magnitude of these optical phenomena in eyes implanted with AcrySof intraocular lenses, as documented in previous publications^23,24.

Results

Seventy-eight eyes from 39 patients with age-related cataracts undergoing phacoemulsification and IOL implantation were enrolled in the study. The cohort included 8 male and 31 female patients, with ages ranging from 52 to 82 years (mean ± standard deviation: 68.8 ± 6.9 years). The preoperative refraction was − 1.78 ± 3.60 D. The implanted IOLs included non-toric CNWTT0 in 42 eyes, toric CNWTT2 in 5 eyes, CNWTT3 in 14 eyes, CNWTT4 in 12 eyes, CNWTT5 in 4 eyes, and CNWTT6 in 1 eye. One patient was lost to follow-up at 12 months.

BUCVA and BDCVA at 12 months postoperatively are shown in Fig. 1. The 95% confidence intervals for BUCVA at 1 m, 60 cm, and 40 cm were 1.208–1.313, 1.061–1.203, and 0.997–1.118, respectively. The corresponding 95% confidence intervals for BDCVA were 1.287, 1.389 at 1 m, 1.121–1.268 at 60 cm, and 1.032–1.150 at 40 cm. All measurements demonstrated visual acuity better than 20/20 at all distances. Measurement results of UCVA, BUCVA, DCVA, and BDCVA are summarized in Table 1. Changes in MRSE throughout the follow-up period are presented in Fig. 2.

Fig. 1.

Binocular uncorrected visual acuity (BUCVA) and binocular distance-corrected visual acuity (BDCVA). Mean ± standard deviation.

Table 1.

Postoperative visual acuity (logMAR).

	5 m	60 cm	40 cm
Monocular uncorrected visual acuity (UCVA)
1 month	−0.06 ± 0.08	0.02 ± 0.13	0.06 ± 0.12
6 months	−0.06 ± 0.08	0.01 ± 0.12	0.03 ± 0.09
12 months	−0.08 ± 0.14	0.02 ± 0.11	0.03 ± 0.09
Binocular uncorrected visual acuity (BUCVA)
1 month	−0.10 ± 0.06	−0.04 ± 0.12	0.00 ± 0.08
6 months	−0.13 ± 0.17	−0.04 ± 0.09	−0.01 ± 0.08
12 months	−0.10 ± 0.06	−0.04 ± 0.09	−0.02 ± 0.08
Monocular distance-corrected visual acuity (DCVA)
1 month	−0.09 ± 0.06	0.01 ± 0.13	0.04 ± 0.12
6 months	−0.09 ± 0.06	0.01 ± 0.11	0.02 ± 0.09
12 months	−0.10 ± 0.06	0.04 ± 0.11	0.02 ± 0.09
Binocular distance-corrected visual acuity (BDCVA)
1 month	−0.12 ± 0.06	−0.05 ± 0.12	−0.01 ± 0.08
6 months	−0.13 ± 0.05	−0.05 ± 0.09	−0.03 ± 0.08
12 months	−0.12 ± 0.05	−0.07 ± 0.09	−0.03 ± 0.08

Mean ± standard deviation.

Fig. 2.

Manifest refraction spherical equivalent. Mean ± standard deviation.

At all postoperative time points, the degree of glistenings was assessed as grade 0. No IOL developed surface light scattering and remained clear throughout the follow-up period. Clinically significant posterior capsule opacification (PCO) occurred in 5 eyes (6.7%), requiring YAG laser capsulotomy. The Kaplan-Meier survival analysis for PCO development is presented in Fig. 3. On a per-patient basis, PCO occurred in 3 cases (7.9%). There were no other postoperative complications or device- or procedure-related adverse events.

Fig. 3.

Kaplan-Meier survival curve for posterior capsule opacification.

At 12 months postoperatively, spectacle independence was achieved in 84.2% of patients (32 out of 38), while the remaining 6 patients required reading glasses. No patient needed glasses for distance vision. Patient satisfaction with vision during daily life was high, as summarized in Table 2, which outlines ratings for various visual tasks. Most patients reported minimal difficulty with activities such as reading, cooking, and watching television, indicating overall satisfaction with their visual outcomes. Table 3 details patient ratings on vision during driving. While satisfaction was high for daytime driving, a greater proportion of patients reported some difficulty with night driving. The incidence and severity of postoperative photic phenomena are summarized in Table 4. All photic phenomena gradually diminished in intensity over time, from 1 month to 12 months postoperatively. At 12 months postoperatively, no patient reported severe glare, halo, or starburst.

Table 2.

Patient ratings on various visual tasks.

	Not difficult	Occasionally difficult	Sometimes difficult	Difficult	Very difficult
Reading fine print (n = 36)	61.1	33.3	5.6	0	0
Reading newspaper or book (n = 38)	81.6	18.4	0	0	0
Cooking (n = 38)	94.7	5.3	0	0	0
Watching television (n = 38)	94.7	5.3	0	0	0
Sport activity	100	0	0	0	0
Watching computer screen (n = 38)	93.5	3.2	3.2	0	0
Shaving or applying makeup (n = 38)	86.8	10.5	2.6	0	0

(%).

Table 3.

Patient ratings on vision during driving.

	Not difficult	Occasionally difficult	Sometimes difficult	Very difficult
Daytime driving (n = 31)	93.5	3.2	3.2	0
Night driving (n = 30)	53.3	20.0	23.3	3.3

(%).

Table 4.

Incident and severity of photic phenomena.

	None	Mild	Moderate	Severe
Glare
1 month	18.8	50.0	25.0	6.3
12 months	56.3	12.5	31.3	0
Halo
1 month	31.3	37.5	12.5	6.3
12 months	50.0	18.8	31.3	0
Starburst
1 month	50.0	18.8	25.0	6.3
12 months	68.8	12.5	18.8	0

n = 16, (%).

Discussion

In this one-year prospective study, no surface light scattering or glistenings were observed in any Clareon PanOptix IOLs. Previous long-term clinical studies have confirmed that surface light scattering remains suppressed in Clareon monofocal IOLs for up to 7 years and that neither glistenings nor surface light scattering developed during a 9-year observation period^10,12. While a longer-term study is warranted, given that Clareon PanOptix and Clareon monofocal IOLs share the same material and are manufactured using similar production processes, it is likely that Clareon PanOptix IOLs will remain free from surface scattering and glistenings for an extended period.

The overall visual function outcomes in this study were highly satisfactory. Both bilateral uncorrected visual acuity (BUCVA) and bilateral distance-corrected visual acuity (BDCVA) exceeded 20/20 at 40 cm, 60 cm, and 5 m. Monocular visual acuity was also consistently good across all distances. These findings suggest that patients achieved excellent visual function, effectively covering distance, intermediate, and near ranges. Several noncomparative studies have reported postoperative visual outcomes with the AcrySof PanOptix IOL. Kohnen et al.²⁵ reported good visual performance with the PanOptix IOL across distances of 4 m, 80 cm, 60 cm, and 40 cm in a 3‑month prospective study, with particularly strong intermediate acuity (logMAR > 0.1) and the best performance at 60 cm. Overall, 87% and 96% of eyes achieved monocular uncorrected distance visual acuity (UDVA) of ≥ 0.10 logMAR and ≥ 0.20 logMAR, respectively. Similarly, 85% and 91% of eyes achieved monocular uncorrected near visual acuity (UNVA) of ≥ 0.10 logMAR and ≥ 0.20 logMAR, respectively, and 50% achieved UNVA of at least 0.00 logMAR. In addition, 83% and 94% of eyes demonstrated uncorrected intermediate visual acuity (UIVA) of ≥ 0.20 logMAR at 80 cm and 60 cm, respectively. In a retrospective case series, Lawless et al.²⁶ reported excellent unaided vision at all test distances with PanOptix. All patients achieved an uncorrected visual acuity of 20/40 Snellen equivalent or better at distance and near, and 88.9% did so at the intermediate distance. Overall, 78.8% of patients achieved UDVA of 0.01 ± 0.10 logMAR (i.e., 20/20 Snellen equivalent or better), and 85.2% achieved a mean UNVA of 0.11 ± 0.04 logMAR. Alió et al.²⁷ conducted a 6‑month prospective case series and demonstrated significant improvements in both uncorrected and corrected VA outcomes by one month after PanOptix implantation, with stability maintained through the six‑month follow‑up. Monocular defocus curves indicated VA better than 0.30 logMAR was preserved within a defocus range of + 0.50 D to − 3.00 D. Consistent with these findings, postoperative outcomes with the Clareon PanOptix IOL in our study were similarly favorable across distance ranges, with stability maintained over the one-year follow‑up period.

Spectacle independence was achieved in 84.2% of patients (32 out of 38). While 6 patients required reading glasses, no patients needed spectacles for distance vision. Previous reports have shown the following results regarding postoperative spectacle independence. Newsom et al.²¹reported spectacle independence rates of 100%, 93%, and 73% for distance, intermediate, and near vision, respectively. In another study by Scheepers et al.²², the proportions of subjects reporting spectacle independence at distance, intermediate, and near were 100%, 100%, and 89%, respectively. Hovanesian et al.¹⁹ found similar outcomes, with 88% of patients implanted with Clareon PanOptix and 83% with AcrySof PanOptix achieving freedom from corrective lenses. Suzuki et al.²⁰ reported that 53 of 59 participants (89.8%) were spectacle-independent postoperatively, while one participant (1.7%) always required glasses and five (6.8%) needed them occasionally. Spectacles for distance and near vision were used by two (3.4%) and four (6.8%) participants, respectively. Our results are favourably comparable with these previous findings.

Patient subjective ratings on daily vision tasks were quite favourable, including reading fine print, reading a newspaper or book, cooking, watching television, sport activity, watching a computer screen, and shaving or applying makeup using a mirror. They were also happy with vision during daytime driving. However, about half of patients complained of some difficulty during night driving. Multifocal IOLs are more likely to cause glare and halos around lights compared to monofocal lenses. These visual disturbances can be particularly bothersome at night, making it difficult to see clearly when driving^28–30. Multifocal lenses can also compromise contrast sensitivity, which is crucial for distinguishing objects in low-light conditions^31,32. This reduced sensitivity can affect the ability to drive safely at night. While some patients may adapt to these visual disturbances over time through neuroadaptation, others may continue to experience discomfort and difficulty with night driving.

The severity of photic phenomena, including glare, halo, and starburst, was evaluated by asking patients at 1 month and 12 months postoperatively. At 1 month, more than half of the patients experienced some form of optical phenomenon. However, over time, the intensity gradually decreased, and by 12 months, fewer than half of the patients reported experiencing glare, halo, or starburst. No patients reported severe glare, halo, or starburst. These results are comparable to or even better than previous findings on PanOptix IOLs^{18–22,33,34}. Mendicute et al.¹⁸ reported that 5.26% and 13.16% of patients experienced “something” or greater levels of bothersome glare and halos, respectively. In a comparative study, Hovanesian et al.¹⁹ found lower rates of severe photic phenomena in Clareon PanOptix eyes compared with AcrySof PanOptix eyes, with 7% versus 15% reporting “very much” or higher glare/halo severity. Suzuki et al.²⁰ observed that glare and halos were completely absent in only 32.2% and 13.6% of cases, respectively, suggesting that most patients experienced at least some degree of dysphotopsia, although it may not have been bothersome in all cases. Newsom et al.²¹ reported that 9% and 12% of subjects were bothered “quite a bit” or “very much” by halos and starbursts, respectively, while no patients reported this level of bothersome glare. Similarly, Scheepers et al.²² found that 8% and 7% of subjects were bothered “quite a bit” or “very much” by halos and glare, respectively, with no patients reporting this severity of starburst symptoms.

During the one-year follow-up period, clinically significant PCO occurred in 6.7%, necessitating YAG laser capsulotomy. Rementería-Capelo et al.³⁵ reported that at the 12-month visit, 85% of eyes in the AcrySof PanOptix group showed no PCO or incipient PCO, while 15% demonstrated moderate PCO. In the Clareon PanOptix group, 89% of eyes showed no PCO or incipient PCO, and 6% demonstrated moderate PCO; additionally, 6% of patients (3 eyes) had undergone YAG capsulotomy by the 12-month visit. Sahin et al.³⁶evaluated outcomes following bilateral implantation of the AcrySof PanOptix trifocal IOL and demonstrated that PCO developed in 19 of 164 eyes (11.6%) at the six-month postoperative follow-up examination. These rates, along with our findings, are notably higher than those reported for Clareon monofocal IOLs, which ranged from 0% to 0.9% at one year^13–15, 4.0% at two years¹⁷, and 4.7% at three years¹⁶. A study analyzing the postoperative Nd: YAG capsulotomy rates of other types of trifocal IOLs using Kaplan-Meier analysis have reported similar or slightly higher rates³⁷. In general, patients with multifocal IOLs tend to report symptoms of PCO earlier and more severely than those with monofocal IOLs, leading to a higher likelihood of undergoing YAG laser capsulotomy sooner^38–41. The higher incidence of Nd: YAG capsulotomy in patients with multifocal IOLs is most plausibly attributable to heightened functional sensitivity to even mild PCO, rather than to an intrinsically greater biologic propensity for opacification³⁸. Multifocal optics reduce contrast sensitivity and increase susceptibility to dysphotopsia such as glare and halos, thereby lowering the clinical threshold at which posterior capsule opacification becomes visually significant and prompts intervention. Contemporary multifocal and monofocal lenses share design features that impede epithelial cell migration, including sharp continuous posterior optic edges, and current evidence does not demonstrate a mechanistic increase in PCO with multifocal designs. Accordingly, observed differences in capsulotomy rates are best interpreted as a manifestation of functional and symptom driven management rather than a true augmentation of posterior capsule opacification biology in eyes with multifocal lenses.

This study has several limitations. First, it was a single-arm study without a control group, making it desirable to compare this cohort with those using other multifocal IOLs to provide a more comprehensive understanding. Second, defocus curve, contrast sensitivity (photopic/mesopic, glare on/off), and straylight (e.g., C‑Quant) were not assessed in this study. These metrics are particularly relevant, as reduced contrast sensitivity and increased straylight can directly impact driving performance at night. Third, we did not use validated Patient-Reported Outcome Measures (PROMs), such as the NEI VFQ-25⁴² or Catquest-9SF⁴³. Instead, we used a custom-made scoring system that has not undergone formal validation. Fourth, photic phenomena were assessed in only 16 patients at a single institution. This limited, single-site assessment may have introduced selection or information bias, as not all patients were evaluated. Moreover, a 4-point scale was used for this assessment rather than a validated dysphotopsia instrument. Fifth, the method for assessing optic clarity had notable constraints. The grading of glistenings was performed during routine outpatient examinations rather than under a standardized protocol with fixed slit-lamp magnification, illumination settings, or pupil sizes. Quantitative imaging, such as Scheimpflug or back-lit densitometry, was not utilized. Furthermore, since a single examiner at each facility conducted the evaluation, inter-observer reliability could not be verified. Nonetheless, in this study, both surface light scattering and glistenings were graded 0 in all cases, with no occurrences detected. Therefore, despite the above constraints, the conclusion that there were no issues with optical clarity remains unchanged. Sixth, the presence of PCO and the indication for YAG capsulotomy were determined subjectively by the physicians, and no standardization was performed. Seventh, as the cohort consisted solely of Japanese patients, the results may not apply directly to populations with different anatomical features. Eighth, the current study did not specifically focus on eyes with biometric extremes, such as extreme axial lengths, or patients with significant ocular surface disease.

In conclusion, the Clareon PanOptix trifocal IOL provided good visual outcomes with high patient satisfaction. During the one-year follow-up period, no cases of surface light scattering or glistenings were observed.

Supplementary Information

Below is the link to the electronic supplementary material.

Author contributions

Y.F. designed the study described here. Y.F., Y.N., T.S., and H.N. recruited participants and collected data. T.O. performed statistical analyses, drafted the main manuscript text, and prepared figures. All authors reviewed and revised the manuscript prior to submission.

Funding

All authors received research support from Alcon for the study’s design, data collection, and analysis.

Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Declarations

Competing interests

Yoshifumi Fujita, Yuya Nomura, Toru Sugita, and Hiroyuki Nomoto received financial support from Alcon for conducting this study. Tetsuro Oshika receives compensation as a consultant from Alcon and Johnson & Johnson Vision. He receives research support from Alcon, Johnson & Johnson Vision, HOYA, and KOWA.