Early Clinical Results of a Newly Developed Continuous Range of Vision Intraocular Lens

Abstract

Introduction

A newly developed diffractive continuous range of vision (CRV) intraocular lens (IOL) (TECNIS Odyssey) was introduced to reduce photic phenomena compared to the previous model (Synergy). This brief report is the first to evaluate the early postoperative outcomes of the new CRV IOL in a Japanese population.

Methods

This retrospective review included 50 eyes of 25 patients with cataracts who underwent bilateral implantation of modified CRV IOLs (models DNR00V and DRT150-375, TECNIS Odyssey). Clinical records of the patients were obtained. One month postoperative assessments included monocular and binocular uncorrected visual acuity (UCVA) and distance-corrected visual acuity (DCVA) at 5 m, 60 cm, and 40 cm. Additionally, binocular photopic contrast sensitivity, defocus curve, spectacle independence, incidence of photic phenomena, and overall patient satisfaction were evaluated.

Results

The mean patient age was 65.2 ± 8.4 years, with a mean IOL power of 17.4 ± 4.7 D. Postoperative binocular UCVA/DCVA (logMAR) at 5 m, 60 cm, and 40 cm was − 0.18 ± 0.06/ − 0.21 ± 0.06, − 0.01 ± 0.08/ − 0.01 ± 0.08, and 0.00 ± 0.08/0.00 ± 0.07, respectively. Contrast sensitivity remained within normal limits at all spatial frequencies. The binocular defocus curve showed DCVA of 0.0 logMAR or better across a range from + 0.5 to − 2.0 D. Spectacle independence was achieved in 64% of patients, whereas the remainder required reading glasses. Reports of glare and starburst were minimal (84% and 76% of patients reported none or minimal, respectively), whereas 52% experienced moderate to severe halos. Overall, 96% of the patients were satisfied or very satisfied with their distance and intermediate vision, and 68% were satisfied with their near vision.

Conclusions

The new diffractive CRV IOL offers simultaneous vision across a broad range, with improved tolerance to photic phenomena, while maintaining comparable visual acuity at far, intermediate, and near distances compared to the previous model.

Key Summary Points

Why carry out this study?

Diffractive intraocular lenses (IOLs), such as trifocal and continuous range of vision (CRV) types, provide superior uncorrected near visual acuity compared to the extended depth of focus IOLs. However, they are often associated with a higher incidence of photic phenomena.

A newly developed CRV IOL, designed to minimize photic phenomena, has recently become available, necessitating clinical evaluation of its performance.

What was learned from the study?

The newly developed CRV IOL achieved a postoperative bilateral uncorrected visual acuity of 20/20 or better in Snellen across distances from 5 m to 40 cm.

The incidence and density of photic phenomena, particularly halos, were reduced compared to those in the previous model.

A significant myopic shift in objective refraction was observed in eyes with the new CRV IOL, indicating that postoperative subjective vision assessments should be interpreted with caution.

Introduction

Presbyopia-correcting (PC) intraocular lenses (IOLs) have been developed to achieve a broader range of vision compared to monofocal IOLs. Recently, ESCRS Functional Vision Working Group proposed a new classification system for PC IOLs based on visual performance, categorizing them into partial-range and full range of field type [1]. Among a full range of field IOLs, diffractive optics, such as bifocal and trifocal IOLs, have gained widespread adoption due to their ability to split incoming light into multiple focal points. Trifocal IOLs have become the predominant choice in this category, offering visual acuity at both distance and near comparable to bifocal IOLs, while also improving intermediate vision. This superiority has been supported by systematic reviews and meta-analyses [2, 3]. Extended-depth of focus (EDOF) IOLs, categorized as partial-range by the ESCRS working group, are another type of PC IOL that has gained popularity in recent years. Although they typically provide inferior near visual acuity compared to trifocal IOLs, they are associated with a lower incidence of photic phenomena, such as glare and halo [4, 5]. The choice of IOL is typically tailored to each patient based on their visual needs and preferences, following a comprehensive explanation of available options.

Recently, a hybrid design that combines the features of EDOF and bifocal IOLs has been added to the full range of field types as the continuous range of vision (CRV) IOL (TECNIS Synergy, Johnson & Johnson Surgical Vision, Santa Ana, CA, USA), and its clinical outcomes have been reported [6–9]. While CRV IOLs provide visual acuity at far, intermediate, and near distances comparable to that of diffractive trifocal IOLs, they have been associated with a higher incidence of photic phenomena [10, 11]. To address these drawbacks, a next-generation CRV IOL, TECNIS Odyssey (J&J Surgical Vision), has been developed. This IOL incorporates a custom echelette design and reduces step heights, aiming to minimize photic disturbances. To the best of our knowledge, no clinical data have yet been published on the performance of this IOL. This brief report presents the first clinical evaluation of early postoperative outcomes with this newly developed CRV IOL.

Methods

This retrospective study was approved by the Institutional Review Board of Tokyo Dental College. Patient informed consent for this study was not required due to the retrospective nature. The study was conducted in accordance with the tenets of the Declaration of Helsinki and the Clinical Trials Act of Japan (Act No. 16, 2017). Patients with cataracts who underwent bilateral implantation of the new diffractive CRV IOLs (DNR00V and DRT150-375) between May and October 2024 were included. This study aimed to evaluate early postoperative visual function of this new CRV IOL. Patients were excluded if they had any ocular conditions affecting visual function, irregular corneal astigmatism, a history of intraocular or corneal surgery, or any other systemic or ophthalmic disease that could influence outcomes.

Preoperative data included demographics (e.g., age), axial length measured using the IOLMaster (Carl Zeiss Meditec AG, Jena, Germany), corneal astigmatism measured with an auto-keratometer (TONOREF II, Nidek, Gamagori, Japan), IOL power, and estimated postoperative refraction calculated using the Barrett Universal II formula. The IOL set in the injector was implanted in the capsular bag following phacoemulsification and aspiration by an experienced surgeon (H. B-M) to remove the cataract.

Primary outcomes of this study were monocular and binocular uncorrected visual acuity (UCVA), distant corrected visual acuity (DCVA) at 5 m, 60 cm, and 40 cm, binocular photopic contrast sensitivity using CSV-1000 (Vector Vision, Fairfield, GT), and binocular defocus curve 1-month postoperatively. The defocus curve was created using a 5-m vision chart, based on the best corrected refractive power of both eyes, and measuring visual acuities when defocused by 0.5 diopter (D) increments from + 1.0 to – 3.0 D. Only the right eye of each patient was analyzed for monocular visual acuity assessments. Secondary outcomes included subjective refraction, objective refractions using an auto-refractometer (TONOREF II, Nidek), spectacle independence, photic phenomena, and patient satisfaction using the questionnaire used in previous studies [11, 12]. The questionnaire consisted of eight items: three addressed photic phenomena, three evaluated visual satisfaction at various distances, and two assessed spectacle usage. For each question, patients selected a single response that best represented their experience. Photic phenomena such as halo, glare, and starburst were rated using a five-point scale: not at all, slight, mild, moderate, and severe. Patient satisfaction with vision was assessed separately for distance vision, intermediate tasks (e.g., cooking, gardening), and near tasks (e.g., reading books, using a smartphone), using a five-point scale: very satisfied, satisfied, not applicable, slightly dissatisfied, and dissatisfied. Spectacle usage was evaluated in terms of frequency (never, rarely, sometimes, always) and the distance at which spectacles were required (distance, intermediate, or near). Response rates for each item were evaluated.

Results

This study included 50 eyes of 25 patients. Patient demographics are summarized in Table 1. The distribution of the implanted IOL models was as follows: DRN00V in 23 eyes, DRT150 in 17 eyes, DRT225 in four eyes, DRT300 in five eyes, and DRT375 in one eye.

Table 1.

Patient demographics

	Mean (SD)	Range
Age, year	65.2 (8.4)	50 to 81
Sex, Female/Male	23/2
Pre-op keratometric astigmatism, D	1.03 (0.77)	0.06 to 4.38
Axial length, mm	24.39 (1.54)	22.54 to 27.61
Selected IOL power, D	17.4 (4.7)	6.5 to 23.0
Estimated post-op refraction	− 0.13 (0.15)	− 0.59 to 0.10

SD standard deviation, D diopter

Monocular and binocular UCVA and DCVA at 5 m, 60 cm, and 40 cm are listed in Table 2. Binocular UCVA and both monocular and binocular DCVAs achieved 0.0 logMAR or better at all distances. Figure 1 illustrates binocular photopic contrast sensitivities from 3 to 18 spatial frequencies in cycles per degree (cpd), all of which were within the normal range. The binocular defocus curve under distance correction is presented in Fig. 2, showing that binocular DCVA of 0.0 logMAR or better was maintained between + 0.5 and − 2.0 D of defocus. Table 3 shows postoperative subjective and objective refractions; objective refractions were shifted by more than − 1.0 D in both spherical and spherical equivalent (SE) values. In the patient-reported questionnaire, 64% reported complete spectacle independence, whereas 36% required spectacles for near tasks. Figure 3 shows the rate of photic phenomena. Glare and starburst were infrequent, whereas halos were reported by over 50% of the patients, and 48% reported it to be moderate to severe. Patient satisfaction was high; 96% were satisfied or very satisfied with their vision at distance and intermediate ranges, and 68% expressed satisfaction with their near vision.

Table 2.

Postoperative monocular and binocular UCVA and DCVA at distances of 5 m, 60 cm, and 40 cm

	UCVA, logMAR Mean (SD)		DCVA, logMAR Mean (SD)
	Monocular	Binocular	Monocular	Binocular
at 5 m	− 0.08 (0.11)	− 0.18 (0.06)	− 0.18 (0.07)	− 0.21 (0.06)
at 60 cm	0.05 (0.11)	− 0.01 (0.08)	0.05 (0.14)	− 0.01 (0.08)
at 40 cm	0.05 (0.14)	0.00 (0.08)	0.05 (0.22)	0.00 (0.07)

UCVA uncorrected visual acuity, DCVA distance corrected visual acuity, SD standard deviation

Fig. 1.

Binocular photopic contrast sensitivities from 3 to 18 spatial frequencies in cycles per degree (cpd)

Fig. 2.

Binocular distance corrected visual acuity (logMAR) between + 1.5 D and − 3.0 D of defocus

Table 3.

Postoperative subjective and objective refraction

	Subjective (SD)	Objective (SD)	P
Spherical power, D	+ 0.12(0.32)	− 0.96 (0.43)	< 0.001
Cylindrical power, D	− 0.23 (0.39)	− 0.69 (0.34)	< 0.001
SE, D	− 0.01 (0.26)	− 1.30 (0.40)	< 0.001

SD standard deviation, SE spherical equivalent, D diopter, P Wilcoxon signed-rank sum test

Fig. 3.

Rate of postoperative halo, glare, and starburst on a five-point scale (not at all, slight, mild,  moderate, and severe) in the patient-reported questionnaire

Discussion

Numerous studies have evaluated the clinical outcomes of PC IOLs, with trifocal IOLs being the most extensively reported among full-range-of-vision designs. A global pooled analysis of trifocal IOLs demonstrated a continuous range of visual acuity of 0.1 logMAR or better, extending from distance to 33 cm, across six geographic regions, including Japan [13]. Furthermore, systematic reviews and meta-analyses have shown that trifocal IOLs offer superior near visual acuity and lower rates of spectacle dependence compared to EDOF IOLs [14, 15]. However, one well-recognized drawback of trifocal lenses is the higher incidence of photic phenomena such as halos and glare.

Clinical results with earlier versions of CRV IOL, which combines features of EDOF and bifocal optics, have shown promising visual acuity across various distances, although photic disturbances remained a concern [6–11].

This brief report assessed the postoperative outcomes of the newly modified CRV IOL, with a focus on visual function and the incidence of photic phenomena. The study employed evaluation methods consistent with those used in previous investigations, allowing for meaningful comparisons across different IOLs.

To observe the optical performance of the new IOL, monocular UCVA and DCVA were measured at 5 m, 60 cm, and 40 cm. The mean postoperative monocular VAs at these distances were comparable to or exceeded those reported for previous CRV IOL models [7]. Binocular VA is known to enhance monocular VA and more accurately reflects functional vision in daily life [16]. A comparison of binocular DCVA at different distances is listed in Table 4. Although the distance of measurement for intermediate varied between 60 and 70 cm, the DCVAs of this report were comparable to those of previous trifocal and CRV IOLs [11–13].

Table 4.

Comparison of binocular DCVA to other IOLs

IOL	Number of cases	Follow-up (months)	5 m (logMAR)	Intermediate (logMAR)	40 cm (logMAR)
TECNIS Synergy6	100	3	− 0.069 ± 0.067	0.012 ± 0.107 66 cm	0.025 ± 0.112
TECNIS Synergy7	27	3	− 0.18 ± 0.07	0.09 ± 0.07 70 cm	− 0.07 ± 0.07
Acrysof PanOptix6	53	3	− 0.024 ± 0.079	0.029 ± 0.135 66 cm	0.075 ± 0.114
Acrysof PanOptix7	27	3	− 0.18 ± 0.07	− 0.06 ± 0.08 70 cm	− 0.04 ± 0.06
Acrysof PanOptix8	557	1 3	− 0.112  − 0.088	− 0.010  − 0.017 60/66 cm	− 0.064 0.021
TECNIS Odyssey (This study)	25	1	− 0.21 ± 0.06	− 0.01 ± 0.08 60 cm	0.00 ± 0.07

UCVA uncorrected visual acuity, IOL intraocular lens

Reduced contrast sensitivity is a concern in eyes with diffractive IOLs. Bilateral contrast sensitivity under photopic conditions remained within the normal range across all spatial frequencies. These results were comparable to those obtained with trifocal and previous CRV IOLs under similar testing conditions [11, 12].

The defocus curve revealed a stable binocular DCVA of 0.00 logMAR between + 0.5 D and − 2.0 D, which aligns closely with previous findings: 0.00 logMAR between 0.0 and -2.0 D for previous CRV IOL, and 0.04 logMAR between 0.0 D and – 2.5 D for trifocal IOLs [7, 17]. These results support visual outcomes at multiple distances.

The new CRV IOL is expected to reduce photic phenomena. However, the perception of photopsia can vary depending on factors such as an individual’s living environment and whether they drive at night. Therefore, it is reasonable to compare the photic phenomena in these cases with reports from the Japanese population. In a previous study on CRV IOL, the percentage of patients reporting moderate to severe halo, glare, and starburst was 85.2%, 96.3%, and 62.9%, respectively [11]. With the new CRV IOL, these rates were reduced by 52%, 16%, and 24%, respectively. Although the new diffractive design appears to lessen the intensity of halos, more than 50% of the patients still reported experiencing them. This should be communicated during the preoperative consultations.

Another noteworthy finding is the myopic shift observed in objective refraction. Differences between objective and subjective refractions in eyes with PC IOLs have been previously reported [18, 19]. Among the studied PC IOLs, the new CRV IOL exhibited the most remarkable myopic shift. This effect should be considered when evaluating corrected visual acuity.

Regarding spectacle independence, 36% of the patients used reading glasses when necessary. This relatively high usage rate was consistent with the findings for other PC IOLs in the Japanese population. This may be attributed to the complexity of the Chinese characters used in the Japanese language (Kanji) compared to the Latin alphabet [12, 20]. The reported rate of spectacle use following the implantation of PC IOL varies widely in the previous reports, ranging from 7.4% to 37% [7, 12, 21]. In most cases, spectacles were used for near tasks such as reading books or performing detailed work. However, patients whose near vision demands are primarily digital, such as using tablets or smartphones, may achieve a higher degree of spectacle independence. Therefore, the rate of spectacle use should be considered as reference data when evaluating the function of PC IOLs.

The limitations of this study include its retrospective design, small sample size, and short follow-up period of only 1 month postoperatively. Further prospective studies with larger cohorts and extended follow-up periods are needed to validate these findings.

Conclusions

Binocular uncorrected visual acuity from 5 m to 40 cm along with contrast sensitivity and the defocus curve following the implantation of the newly developed diffractive CRV IOL were comparable to those observed with trifocal and previous CRV IOL. As the first study to evaluate postoperative outcomes, these findings suggest that the new CRV IOL is a viable option among PC IOLs with full range of field. Halos were the most frequently reported photic phenomenon; however, their intensity was reduced compared to that of the previous version of the CRV IOL. The possibility of experiencing halos should be communicated during preoperative counseling.

Author Contributions

Conceptualization: Hiroko Bissen-Miyajima, Keiichiro Minami; Investigation: Hiroko Bissen-Miyajima, Momoka Midorikawa, Rina Fujisaki, Yuka Ota; Project administration: Hiroko Bissen-Miyajima; Methodology: Yuka Ota, Momoka Midorikawa; Formal analysis: Keiichiro Minami; Validation and Writing–original draft: Hiroko Bissen-Miyajima; Writing–review, editing, and approval: all authors.

Funding

No funding or sponsorship was received for this retrospective study or publication.

Data Availability

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

Declarations

Conflict of Interest

Hiroko Bissen-Miyajima reports grants, consultant, and speaker honorarium from Alcon and Johnson & Johnson Surgical Vision and speaker honorarium from BVI and Hoya. Hiroko Bissen-Miyajima is an Editorial Board member of Ophthalmology and Therapy. Hiroko Bissen-Miyajima was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Yuka Ota reports grants and speaker honoraria from Johnson & Johnson Surgical Vision. Keiichiro Minami reports a patent pending from Tomey. Momoka Midorikawa, Rina Fujisaki, and Rie Honda declare that they have no financial interests.

Ethical Approval

This retrospective study was approved by the Institutional Review Board at Tokyo Dental College (Approval No.1258). This study was conducted in accordance with the tenets of the Declaration of Helsinki and the Clinical Trials Act of Japan (Act No. 16, 2017).