Clinical investigation of a monofocal intraocular lens with enhanced intermediate vision and a rotationally asymmetric multifocal intraocular lens with near addition of + 1.5 diopters

doi:10.21203/rs.3.rs-3214837/v1

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Clinical investigation of a monofocal intraocular lens with enhanced intermediate vision and a rotationally asymmetric multifocal intraocular lens with near addition of + 1.5 diopters

https://doi.org/10.21203/rs.3.rs-3214837/v1

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Background: The Lentis® Comfort LS-313 MF15 (Oculentis, Berlin, Germany) is a latest-generation rotationally asymmetric multifocal intraocular lens (IOL) with a near-addition of +1.5 diopters. The newly developed monofocal lens Tecnis Eyhance™ DIB00V (Johnson & Johnson Vision, Santa Ana, CA, USA) provides favorable distance vision as well as an aspherical lens with increased power from the periphery to the center, plus strengthened intermediate vision. The purpose of this study was to compare the short-term postoperative visual functions of patients implanted with an Eyhance IOL with that of patients implanted with a Lentis IOL.

Methods: We retrospectively studied 36 patients who had undergone cataract surgery with implantation of an Eyhance IOL (19 eyes in 19 patients) or a Lentis IOL (17 eyes in 17 patients). The following were evaluated at the 3-month post-operation clinic visit: the monocular uncorrected and corrected distance (5 m) visual acuity (UDVA and CDVA), the uncorrected and corrected intermediate (70 cm) visual acuity (UIVA, CDVA), additional plus diopter for intermediate vision (Add D) and the area under log contrast sensitivity function (AULCSF) under photopic with glare, photopic without glare, mesopic with glare, and mesopic without glare conditions. A defocus curve was made from each patient’s manifest refraction.

Results: There were no significant post-operative differences in the UDVA, CDVA, UIVA, CIVA, or additional plus Dfor intermediate vision between the Eyhance and Lentis groups. The post-operative AULCSF for the mesopic with glare condition tended to be wider in the Eyhance group than the Lentis group while that for the mesopic without glare condition was significantly wider for the Eyhance group than the Lentis group.

At the defocus level of -0.5D, visual acuity was significantly better maintained in the Eyhance group than the Lentis group, but at the defocus level of -3.0D, visual acuity was significantly better maintained in the Lentis group than the Eyhance group.

Conclusion: Our analyses revealed that at 3 months post-operation the clinical outcomes of distance and intermediate visual acuity without correction were similar for patients with an implanted Eyhance IOL and those with a Lentis IOL.

Tecnis Eyhance

Lentis Comfort

area under log contrast sensitivity function

uncorrected distance visual acuity

uncorrected intermediate visual acuity

cataract

replacement lens.

Cataract blindness is a public health problem of major proportions in developing countries [1], and the risk of developing blindness from a cataract is increasing with increasing life expectancy [2]. Fortunately, cataracts can now be treated with a stable and safe technique. The number of ophthalmic surgeries including cataract surgery is increasing in Japan, and costs for cataract surgeries represent the largest proportion of healthcare expenditures for ophthalmic surgeries [3]. The implantation of a multifocal intraocular lens (IOL) after cataract surgery provides good visual acuity for both distance and intermediate and near vision, and it reduces patients’ dependence on glasses. The most frequently implanted IOLs are still monofocal lenses, due to their relatively low cost, their good outcome for distance, and the low incidence of photic phenomena including halo and glare after surgeries [4].

The Lentis® Comfort LS-313 MF15 (Oculentis, Berlin, Germany) is a latest-generation rotationally asymmetric multifocal IOL with a near-addition of + 1.5 diopters (D). This Lentis IOL is designed to provide intermediate vision while suppressing disturbing photic phenomena [5–10]. In Japan, cataract surgery using the Lentis IOL is covered by medical insurance, and the surgery can be performed at the same cost as that of cataract surgery using a monofocal IOL. The newly developed monofocal lens Tecnis Eyhance DIB00V (Johnson & Johnson Vision, Santa Ana, CA, USA) provides favorable distance vision as well as an aspherical lens with increased power from the periphery to the center, plus strengthened intermediate vision [4, 11–13]. Cataract surgery using the Eyhance IOL is also covered by medical insurance in Japan. There has been only one report of a comparison of the visual-function clinical outcomes between cataract surgeries using the Eyhance IOL and those using the Lentis IOL [14].

We thus conducted the present study to compare the short-term postoperative visual-function clinical outcomes in patients implanted with an Eyhance IOL versus a Lentis IOL.

Patients

The institutional review board of the International University of Health and Welfare Narita Hospital approved this study (approval no. 21-Nr-062), which was retrospective in nature, and all patients provided informed consent for participation in accord with the tenets of the Declaration of Helsinki. We analyzed the cases of patients who had undergone cataract surgery with the implantation of an Eyhance IOL or a Lentis IOL in one or both eyes at the Department of Ophthalmology, International University of Health and Welfare during the period from October 1, 2021 to December 1, 2022. Patients were excluded if they had high myopia over − 7.0 D, amblyopia, any type of corneal opacity, glaucoma, uveitis, optic neuropathy, vitreous or retinal disease, or choroidal vascular disease, or if they had undergone an intraocular surgery including corneal or refractive surgery. If patients received the cataract surgery in both eyes, data of the right eye were used for the analysis. Ultimately, we compared outcomes for 19 eyes of 19 patients in whom the Eyhance IOL was implanted and 17 eyes of 17 patients in whom the Lentis IOL was implanted.

Cataract surgery technique

All surgeries were performed under local and topical anesthesia by two surgeons (T.S. and T.U.). The surgeries were performed using a standard technique of phacoemulsification with a self-sealing 2.4-mm incision. In all cases, IOL implantation in the capsular bag was performed after the aspiration of cortical matter via continuous curvilinear capsulorhexis. No intraoperative or postoperative problem or side effect occurred. The target refraction was emmetropia. The SRK-T formula obtained by IOL-Master 700 biometric technology (Carl Zeiss Meditec, Jena, Germany) was used to determine the IOL power.

Evaluation parameters

The following parameters were evaluated at pre-operation: gender, age, the monocular corrected distance (5 m) visual acuity (CDVA), and the manifest refraction spherical equivalent (MRSE). The refractive error was estimated using the biometry tool TOREF Ⅲ (Nidek Co., Gamagori, Japan), followed by manifest refraction to determine the CDVA; the manifest refraction results were also used to calculate the manifest refraction spherical equivalent (MRSE, diopters [D]). Visual acuity was corrected by log MAR, the pupil diameter (mm) under photopic and mesopic conditions by CASIA2 (Tomey, Nagoya, Japan), and the contrast sensitivity.

The contrast sensitivity test used a CGT-2000 contrast glare tester (Takagi Seiko Co., Tokyo). The contrast sensitivity was measured mono-ocularly at six spatial frequencies (6.3°, 4°, 2.5°, 1.6°, 1°, and 0.64°) under photopic conditions (average luminance of 100 candelas/square meter [cd/m²]) and mesopic conditions (average luminance of 5 cd/m²) with refractive correction. To provide a glare stimulus, 12 circularly aligned white lights (light-emitting diodes [LEDs]) with a brightness of 40,000 lux (lx) under mesopic conditions and 100,000 lx under photopic conditions were added. The contrast sensitivity test was carried out in the following order: photopic with glare, photopic without glare, mesopic with glare, and mesopic without glare [15]. The contrast sensitivity results are presented by the area under log contrast sensitivity function (AULCSF) for each condition [16].

The following parameters were evaluated at 3 months post-operation: the monocular uncorrected distance (5 m) visual acuity (UDVA), CDVA, MRSE, uncorrected intermediate (70 cm) visual acuity (UIVA), corrected intermediate (70 cm) visual acuity (CIVA), and additional plus D (Add D) for intermediate (70 cm) distance, the pupil diameter under photopic and mesopic conditions, and the AULCSF of photopic with glare, photopic without glare, mesopic with glare, and mesopic without glare conditions. A defocus curve for 13 different levels of defocus from + 3.0 to − 3.0 D in steps of 0.5 D was made from the patient’s manifest refraction.

Statistical analysis

The data of continuous variables are presented as the means ± SDs. The Yates χ²-test, unpaired t-test, and Mann-Whitney U-test were used for the comparison of pre- and post-surgery data in the Lentis and Eyhance groups. P-values < 0.05 were considered significant. All statistical analyses were performed with EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan), which is a graphical user interface for R (The R Foundation for Statistical Computing, Vienna, Austria).

Table 1 presents a comparison of the pre-operative characteristics of the patients in the Eyhance and Lentis groups. The average patient age was 72.7 ± 6.9 years in the Eyhance group and 70.1 ± 11.7 years in the Lentis group (p = 0.41). The male:female ratio did not differ significantly between the Eyhance and Lentis groups (8:11 vs. 7:10; p = 0.78). The pre-operative CDVA, MRSE, and axial length also did not differ significantly between the groups.

Table 1

Preoperative characteristics of patients in the Eyhance and Lentis groups
Parameter	Eyhance™	Lentis®	p-value
Eyes, n	22	20
Males : females, n	6 : 9	6 : 4	0.57^a
Right : left	13 : 9	9 : 11	0.55^a
Age, yrs	73.5 ± 6.2	70.1 ± 10.3	0.19^b
CDVA, log MAR	0.22 ± 0.19	0.18 ± 0.28	0.57^b
MRSE, D	−0.21 ± 3.41	−0.57 ± 1.38	0.66^c
Axial length, mm	23.5 ± 1.3	24.0 ± 0.74	0.11^b
IOL power, D	21.1 ± 3.7	19.4 ± 2.3	0.09^b
Pupil diameter, mm
Photopic	3.62 ± 0.96	3.07 ± 1.05	0.10^b
Mesopic	4.70 ± 1.02	4.55 ± 1.25	0.68^b
AULCSF:
Photopic with glare	0.93 ± 0.37	1.06 ± 0.42	0.29^b
Photopic without glare	1.12 ± 0.34	1.33 ± 0.34	0.06^b
Mesopic with glare	0.62 ± 0.36	0.81 ± 0.46	0.15^b
Mesopic without glare	0.96 ± 0.31	1.11 ± 0.29	0.13^b
Data are means ± SDs.
^a Yates χ²-test. ^bUnpaired t-test. ^cMann-Whitney U-test. AULCSF, area under log contrast sensitivity; CDVA, corrected distance visual acuity; D, diopters; IOL, intraocular lens; MRSE, manifest refraction spherical equivalent.

The pupil diameter in the photopic and mesopic conditions also did not differ significantly between the two groups. The preoperative AULCSF values of the Lentis group in the photopic with glare conditions (Eyhance 0.86 ± 0.37, Lentis 1.12 ± 0.34; p = 0.02) and mesopic without glare conditions (Eyhance 0.89 ± 0.31, Lentis 1.09 ± 0.25; p = 0.03) were significantly wider than those of the Eyhance group. The AULCSF in the photopic without glare (Eyhance 1.11 ± 0.31, Lentis 1.30 ± 0.33; p = 0.06) and mesopic with glare conditions (Eyhance 0.57 ± 0.35, Lentis 0.75 ± 0.41; p = 0.09) tended to be wider in the Lentis group, but not significantly.

The 3-month postoperative clinical outcomes in the Eyhance and Lentis groups are summarized in Table 2. There were no significant between-group differences in the UDVA, CDVA, MRSE, UIVA, CIVA or Add D. The post-operative pupil diameter in the photopic and mesopic conditions also did not differ significantly between the two patient groups.

Table 2

Clinical outcomes in the Eyhance and Lentis groups at 3 months post-surgery
Parameter	Eyhance™	Lentis®	p-value
UDVA, log MAR	0.07 ± 0.17	0.07 ± 0.17	0.95^a
CDVA, log MAR	−0.09 ± 0.07	−0.08 ± 0.05	0.83^a
MRSE, D	−0.27 ± 0.26	−0.21 ± 0.45	0.63^b
UIVA, log MAR	0.09 ± 0.12	0.06 ± 0.12	0.42^a
CIVA, log MAR	−0.07 ± 0.08	−0.08 ± 0.06	0.56^a
Add, D	0.56 ± 0.40	0.70 ± 0.43	0.27^a
Pupil diameter, mm
Photopic	3.18 ± 0.77	3.11 ± 1.05	0.80^a
Mesopic	4.15 ± 0.97	4.25 ± 1.32	0.78^a
AULCSF
Photopic with glare	1.56 ± 0.19	1.46 ± 0.15	0.09^a
Photopic without glare	1.61 ± 0.19	1.55 ± 0.19	0.28^a
Mesopic with glare	1.26 ± 0.33	1.23 ± 0.24	0.76^a
Mesopic without glare	1.47 ± 0.19	1.36 ± 0.18	0.06^a
Data are means ± SDs.
^aUnpaired t-test. ^bMann-Whitney U-test. Add, additional plus diopter for intermediate (70 cm); AULCSF, area under log contrast sensitivity; CDVA, corrected distance visual acuity; CIVA, corrected intermediate visual acuity (70 cm); MRSE, manifest refraction spherical equivalent; UDVA, uncorrected distance visual acuity; UIVA, uncorrected intermediate visual acuity (70 cm).

The post-operative AULCSF under the mesopic with glare condition tended to be higher in the Eyhance group than the Lentis group (Eyhance 1.32 ± 0.15, Lentis 1.19 ± 0.26; p = 0.07) whereas that in the mesopic without glare condition was significantly wider in the Eyhance group than the Lentis group (Eyhance 1.47 ± 0.17, Lentis 1.31 ± 0.17; p = 0.009).

The defocus curves of the Eyhance and Lentis groups across the 13 defocus levels (+ 3D to − 3D) at 3 months post-surgery are depicted in the Fig. 1. At the defocus level of -0.5D, visual acuity was significantly better maintained in the Eyhance group than the Lentis group (Eyhance − 0.09 ± 0.07, Lentis − 0.03 ± 0.08; p = 0.04). On the other hand, at the defocus level of -3.0D, visual acuity was significantly better maintained in the Lentis group than the Eyhance group (Eyhance 0.71 ± 0.23, Lentis 0.45 ± 0.24; p = 0.001).

Patients today have increasingly higher expectations for cataract surgery; in particular, they expect to gain or maintain visual acuity at intermediate distances, for instance to operate computers and smartphones or monitor their car dashboard [6, 13]. The Lentis IOL is a latest-generation rotationally asymmetric multifocal IOL with + 1.5 D near addition, and it provides favorable distance and intermediate visual acuity, with high contrast sensitivity [4, 11–13]; however, the near visual acuity of the Lentis IOL was confirmed to be insufficient for reading small text [5–10].

The Eyhance IOL is a novel monofocal IOL that was reported to provide favorable distance vision and strengthened intermediate vision [4, 11–13]. In Japan, a Lentis IOL and Eyhance IOL can be implanted at the same cost as a conventional monofocal IOL implantation. We thus conducted the present analyses to determine whether there is a difference in ophthalmic clinical outcomes of distance and intermediate visual acuity and contrast sensitivity between patients implanted with an Eyhance IOL and those implanted with a Lentis IOL. Comparison of the patients’ pre-operative characteristics detected no significant difference between the Eyhance IOL and Lentis IOL groups in gender distribution, age, CDVA, MRSE, axial length, or pupil diameter under either the photopic or mesopic conditions. The pre-operative AULCSF of the Lentis group under the photopic with glare and mesopic without glare conditions were significantly wider than that of Eyhance group. The AULCSF under the photopic without glare and mesopic with glare conditions in the Lentis group tended to be wider, but not significantly.

With these patient backgrounds, we then compared the ophthalmic clinical outcomes of the patients in the Eyhance and Lentis groups at 3 months post-surgery. The UDVA at 5 m, CDVA at 5 m, MRSE, UIVA at 70 cm, CIVA at 70 cm, Add D, and pupil diameter were not significantly different between the Eyhance and Lentis groups. Pupil diameter is an important factor that affects visual function after implantation of IOLs, especially multifocal IOLs [17–19]. In the current study, since the pupil diameters under each condition showed no difference between the two groups, their effect can be ignored.

In a previous comparison of 3-month post-surgery clinical outcomes of patients who received an Eyhance IOL or Lentis IOL [14], the UDVA of the Lentis group was 0.10 ± 0.24 and that of the Eyhance group was 0.14 ± 0.27, whereas the uncorrected near-vision acuities at 40 cm in the Lentis and Eyhance groups were 0.30 ± 0.22 and 0.18 ± 0.26, respectively. In the present investigation, we evaluated the patients’ intermediate visual acuity at 70 cm and found no significant between-group difference. In our evaluation of the defocus curves, at the defocus level of -0.5D, visual acuity was significantly better maintained in the Eyhance group than in the Lentis group. On the other hand, at the defocus level of -3.0D, the visual acuity was significantly better maintained in the Lentis group than in the Eyhance group. There was no significant difference between the two groups at other defocus levels. These differences may be attributed to the fact that Lentis is a rotationally asymmetric multifocal IOL with a near-addition of + 1.5. However, the UDVAs in the Eyhance and Lentis groups were identical at 0.07 ± 0.17. In addition, the UIVAs in the Eyhance and Lentis groups were 0.09 ± 0.12 and 0.06 ± 0.12, respectively. Together, our findings indicate that implantation of either the Eyhance or Lentis IOL provides satisfactory results for distance and intermediate visual acuity without correction.

The pre-operative differences and tendencies of AULCSF were canceled out,

and no significant difference between the two groups was observed in the photopic condition at 3 months post-surgery. However, we observed that the post-operative AULCSF under the mesopic with glare condition tended to be wider in the Eyhance group than the Lentis group, while that in the mesopic without glare condition was significantly wider in the Eyhance group than the Lentis group. Most multifocal IOLs divide the light into several focal spots, which diminishes the visual quality; the incidence of glare is thus greater for multifocal IOLs than for monofocal IOLs [20–22]. It cannot be denied that this may have affected our results. Since there were no complaints about halos or glare by any patients, the difference may be clinically unimportant. However, there may be a slight advantage to Eyhance implantation when it comes to driving at night. In any case, both the Eyhance IOL and Lentis IOL meet one of the main expectations of patients, i.e., freedom from the need to wear glasses for intermediate distances (e.g., to see car dashboards), and both may be cost-effective.

There are some study limitations to address. (1) The study period was only 3 months, and longer-term investigations are thus necessary. (2) The study design was retrospective and there was a lack of randomization. It was thus not possible to precisely match the patients before surgery. (3) We did not evaluate the ocular dominance of the eyes that underwent surgery. Ocular dominance is the propensity to favor visual input from one eye over the other [23, 24], and it may have slightly affected our results. Further careful validation studies with more subjects and a randomized trial study are necessary to clarify the difference in clinical effects between Eyhance and Lentis IOL implantation.

Our analyses showed that the clinical outcomes of distance and intermediate visual acuity between patients with an implanted Eyhance IOL and those with a Lentis IOL are similar at 3 months’ post-operation. Both the Eyhance IOL and the Lentis IOL provide satisfactory results for distance and intermediate visual acuity without correction.

IOL, intraocular lens; D, diopters; CDVA, corrected distance visual acuity; MRSE, manifest refraction spherical equivalent; cd/m², candelas/square meter; LEDs, light-emitting diodes; lx, lux; AULCSF, area under log contrast sensitivity function; UDVA, uncorrected distance visual acuity; UIVA, intermediate visual acuity; CIVA, intermediate visual acuity.

Authors’ contributions

TS conceived of the present study. MW and TS wrote the main manuscript text and prepared the Figure. TS verified the analytical methods. TU supervised the findings of this work. All authors reviewed the manuscript. The authors read and approved the final manuscript.

Funding This study did not receive financial support from the private, public, or not-for-profit sectors.

Availability of data and materials

The datasets generated and/or analyzed during the current study are not publicly available due to data privacy concerns but are available from the corresponding author on reasonable request.

Declarations, ethics approval and consent to participate

The experimental protocol was approved by the Ethics Committee of the institutional review board of the International University of Health and Welfare Narita Hospital (approval no. 21-Nr-062) and was conducted according to the principles of the Declaration of Helsinki. All patients provided written informed consent to use their data for analysis and publication

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests

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No competing interests reported.

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Clinical investigation of a monofocal intraocular lens with enhanced intermediate vision and a rotationally asymmetric multifocal intraocular lens with near addition of + 1.5 diopters

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Abstract

Figures

BACKGROUND

METHODS

Patients

Cataract surgery technique

Evaluation parameters

Statistical analysis

RESULTS

DISCUSSION

CONCLUSION

Abbreviations

Declarations

References

Additional Declarations

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