Hida 2024
Hida 2024
Hida 2024
ARTICLE
Purpose: To compare clinical outcomes after implantation of than in Group 2 (combination of ZFR00V/ICB00). The binocular
TECNIS Synergy (ZFR00V) intraocular lenses (IOLs) in both eyes defocus curve demonstrated better visual acuity at 40 cm ( 2.00 D)
and implantation of the TECNIS Synergy and TECNIS Eyhance and 50 cm ( 2.50 D) in Group 1 than in Group 2 (P < .05). Similar
(ICB00) combination in patients undergoing cataract surgery. contrast sensitivity values were observed between the 2 groups.
Patients in Group 1 reported higher satisfaction (completely sat-
Setting: Department of Cataract, Hospital Oftalmológico de Bra- isfied) than those in Group 2 (P < .05). However, halos and glare
silia (HOB), Brası́lia, Brazil. were more pronounced in Group 1 than in Group 2 (P < .05).
Design: Prospective, interventional, randomized, parallel-group study. Conclusions: Both presbyopia-correcting IOL combinations
showed similar binocular visual acuity results. Group 1 demon-
Methods: Patients were categorized into 2 groups: Group 1: strated enhanced visual acuity in the defocus curve at 40 cm
ZFR00V IOL was implanted in both eyes. Group 2: An ICB00 IOL ( 2.00 D) and 50 cm ( 2.50 D). Comparable contrast sensitivity
was implanted in the dominant eye, and a ZFR00V IOL was im- outcomes were observed in both groups. Patients were more
planted in the nondominant eye. completely satisfied in Group 1 than in Group 2, despite the higher
frequency of postoperative nighttime halos and glare.
Results: Visual acuity was similar between the 2 groups (95%
CI <0.1 logMAR). A superior visual acuity of ≥ 20/25 (at 2.00 J Cataract Refract Surg 2024; 50:401–406 Copyright © 2023 Published by
to 2.50 diopters [D]) was achieved in Group 1 (bilateral ZFR00V) Wolters Kluwer on behalf of ASCRS and ESCRS
M
onofocal intraocular lenses (IOLs) were de-
veloped to replace the focusing power of crys- in the market are equipped with either 2 optical zones,
talline lenses (typically after cataract surgery) by catering to distant and near vision, or 3 optical zones,
providing good visual function through a fixed and simple accommodating distant, intermediate, and near vision. The
focal length, which corrects distant vision. However, several search for the best presbyopia correction method, with
pseudophakic patients with monofocal IOL implants re- greater patient satisfaction and better visual results, leads to
quire reading spectacles to compensate for the loss of clear the search for better intraocular lenses.16–22
vision at intermediate or near distances.1–10 The TECNIS Eyhance ICB00 IOL (Johnson & Johnson
Advanced IOL designs, including multifocal IOLs, are Vision) is a refractive monofocal lens with a modified
currently used in clinical practice to treat presbyopia in anterior surface that aims to improve the range of vision
Submitted: August 29, 2023 | Final revision submitted: November 9, 2023 | Accepted: November 21, 2023
From the Department of Ophthalmology, Hospital Oftalmológico de Brası́lia (HOB), Brası́lia, Brazil (Hida, Cortez, Tzelikis); Department of Ophthalmology, University of Sao
Paulo (HC-FMUSP), Sao Paulo, Brazil (Hida, Carricondo); Department of Ophthalmology and Visual Sciences, Federal University of Sao Paulo (UNIFESP), Sao Paulo,
Brazil (Moscovici, Nose); Department of Ophthalmology, Hospital Visão Laser, Santos, Brazil (Moscovici, Colombo-Barboza, Tzelikis); Department of Ophthalmology,
Renato Ambrosio Research Center (CEORA), Brası́lia, Brazil (Cortez, Tzelikis, Motta, De Medeiros).
Sponsored by Johnson & Johnson Vision. Funded by Hospital Oftalmológico de Brası́lia (HOB) and Renato Ambrosio Eye Research Center (CEORA). The facilities of both
institutions were used during the conduction of this study.
Corresponding author: Wilson Takashi Hida, PhD, MD, Department of Ophthalmology, Hospital Oftalmológico de Bras ı́l ia (HOB), Bras ı́lia, Brazil. Email: takashi.
doc@gmail.com.
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402 BILATERAL SYNERGY AND BLENDED EYHANCE/SYNERGY IOL
compared with standard monofocal IOLs. However, Ey- tonometry measurements; and fundoscopic examinations.
hance cannot be classified as an extended depth-of-focus Distant visual acuity was quantified using Early Treatment
Diabetic Retinopathy (ETDRS) charts positioned 4 m away and
(EDOF) IOL according to the American National Standard
measured in logMAR. Near visual acuity was determined using
IOL criteria. The Eyhance IOL compensates for the spherical the Radner Reading Charts. Furthermore, a series of auxiliary
aberrations of the cornea. Furthermore, it reportedly en- tests were performed, including IOLMaster 700 (Carl Zeiss
hances intermediate-to-distant vision when compared with Meditec AG), OPD Scan (Nidek Co., Ltd.), and Pentacam
conventional monofocal IOLs.10–14 (Oculus Optikgeräte GmbH).
The TECNIS Synergy ZRF00V IOL (Johnson & Johnson
Randomization Process
Vision) is a hybrid of a diffractive bifocal and EDOF IOL or
Lens randomization was performed only for the dominant eye,
a multifocal refractive–diffractive lens (dual-technology which was selected through stenopeic orifice examination and eye
diffractive lens) and EDOF IOL. In addition, the lens’ occlusion. We verified the eye in which the image disappeared when
anterior surface is configured with a negative spherical occluded and assigned it as the dominant eye. The Randomizer App
aberration to counterbalance the cornea’s positive spherical (Giannis Macheras, Apple Store) was used to randomly select which
IOL would be implanted in the dominant eye.
aberration.15,16,20–30
The advantages associated with the utilization of the
Study IOLs
TECNIS Synergy IOL in both eyes (hereinafter referred to The ZFR00V IOL and control ZFR00V/ICB00 IOL were used in
as the ZFR00V IOL) and the potential enhancement of the study.
patient outcomes associated with the combined utilization The ICB00 is a single-piece biconvex hydrophobic acrylic IOL
of the TECNIS Eyhance and TECNIS Synergy IOLs (from that features a continuous power profile on its aspheric anterior
surface, which is devoid of diffractive rings or zones. Its overall
now on referred to as ZFR00V/ICB00) remain unaddressed
diameter is 13 mm, and the optics diameter is 6 mm. The power
because of the lack of substantial evidence.15,16,20–22 profile consistently increases from the periphery toward the center
Thus, we aimed to compare the clinical results associated of the lens. It offers monofocal-level distant visual performance
with the use of ZFR00V in both eyes with those associated with minimal photic effects while simultaneously providing in-
with the use of ZFR00V/ICB00. termediate vision at 66 cm.10–14
The ZFR00V is a single-piece 6.0 mm biconvex hydrophobic
acrylic IOL. The IOL features technology to address chromatic
METHODS aberrations and enhance contrast sensitivity. Its overall diameter is
This prospective, interventional, randomized, parallel-group 13 mm, and the optics diameter is 6 mm. The optical diffraction
study encompassed a cohort of patients and was conducted in structure is strategically positioned within the central optical zone,
the Department of Cataract at the Hospital Oftalmológico de resulting in the recognizable ring structure within the lens. This
Brasilia. Informed consent was obtained from all the patients design element splits incoming light, generating intermediate and
before the surgery. The study was approved by the local ethics near-addition powers.15–18
committee (No: 42915320.3.0000.5667). All the procedures were
performed in accordance with the ethical standards set forth by Surgical Procedure
the responsible human experimentation committee and the tenets All the procedures were consistently conducted by the same
of the Declaration of Helsinki. experienced surgeon, following standard protocols. Phacoe-
mulsification was performed through a temporal clear corneal
Preoperative Evaluation and Patient Selection incision, and a foldable posterior chamber IOL (ZRF00V or
Patients were categorized into 2 groups: Group 1: ZFR00V IOL ICB00) was inserted into the capsular bag. The surgeries were
was implanted in both eyes. Group 2: An ICB00 IOL was im- performed using the Centurion phacoemulsification device (Al-
planted in the dominant eye, and a ZFR00V IOL was implanted in con Laboratories, Inc.).
the nondominant eye. The same irrigation solution (balanced salt solution, Alcon
Laboratories, Inc.) and viscoelastic device (sodium hyaluronate
Inclusion Criteria 3.0%—chondroitin sulfate 4.0%, Viscoat, Alcon Laboratories, Inc.)
The inclusion criteria for adults were as follows: (1) cataracts in were consistently used across all cases. The surgeon refrained from
both eyes, (2) able to comprehend and provide informed consent, injecting intracameral antibiotics because there is no commer-
(3) who can complete all the required postoperative follow-up cially available formulation in our country.
procedures, (3) with a calculated lens power between 13.0 and 30.0
diopters (D), (4) with a preoperative corrected distant visual acuity Postoperative Evaluation
(CDVA) worse than 0.20 logMAR (0.22 logMAR or worse) in at The patients were evaluated on the following postoperative days:
least 1 eye, (5) with a potential postoperative CDVA of 0.20 1st, 14th, 30th, 60th, 90th, and 180th. The following clinical data
logMAR or better in both eyes, (6) with a preoperative regular were collected after 6 months: binocular CDVA and uncorrected
corneal astigmatism of <1.00 D, and (7) with a clear intraocular distant visual acuity (UDVA) at 4 m, intermediate visual acuity at
media, except for cataracts, in both eyes. 60 cm, and near visual acuity at 40 cm.
The other measures evaluated were tolerance of refractive
Exclusion Criteria error testing, photopic and mesopic contrast sensitivity with
The exclusion criteria were as follows: patients (1) with corneal, and without glare, and reading speeds for near and in-
retinal, or optic nerve disease, or history of refractive surgery, (2) termediate distances. In addition, quality of life (QoL) ques-
with high axial myopia (axial length >26 mm), (3) with a post- tionnaires (Cat Quest 9SF and TyPE Spec) were administered
operative corneal astigmatism of >1.00 (D), and (4) with intra- to all patients.23,24
operative and postoperative complications. All patients were administered uniform postoperative medi-
Comprehensive ophthalmological assessments were conducted in cations: 1% prednisolone acetate was administered in a regression
all patients, including evaluations of their refractive status; distant, regimen every 7 days over 1 month, starting every 4 hours.
intermediate, and near visual acuities; slitlamp examinations; Moxifloxacin (0.5%) was administered every 4 hours for 7 days.
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BILATERAL SYNERGY AND BLENDED EYHANCE/SYNERGY IOL 403
Defocus Curve
Binocular defocus curves were obtained for all participants
under photopic conditions 3 months postoperatively. The step
size between measurements was set at 0.50 D and encompassed a
range from +2.00 to 5.00 D. Visual acuity was evaluated using Figure 1. Binocular UDVA of both groups 6 months postoperatively.
the logMAR scale, with ETDRS optotypes (Precision Vision)
positioned at a distance of 4 m. All participants were tested with
the best distant-vision correction to account for residual re- patients (116 eyes). We excluded 1 patient because of
fractive errors. retinal detachment and another because of the formation of
Subjective depth of focus was determined using absolute and an epiretinal membrane.
relative criteria. The absolute criterion was calculated based on
vergences (in diopters) that yielded visual acuity values of ≤0.1 The age of the study participants ranged from 53 to 79
logMAR. The relative criterion was established by identifying years. There was no significant difference in the sex,
vergences (in diopters) that decreased by 0.1 logMAR from each dominant eye, UDVA, cylinder, and photopic pupil size
individual’s best visual acuity achieved at zero vergences. between the 2 groups (P > .05 for all). We only found an age
difference (Table 1).
Statistical Analysis
SPSS (v. 24.0 for Windows, IBM Corp.) was used for the statistical Refractive and Visual Acuity Results
analyses. The Kolmogorov-Smirnov test was used to evaluate the
normality of the data distribution. When possible, the Fisher exact At the 6-month postoperative follow-up, the UDVA of
test was used for parameter comparisons between the IOLs. When Group 1 was found to be noninferior to that of Group 2
parametric analysis was not possible, the Mann-Whitney U test was across all distances (95% CI <0.1 logMAR) (Figure 1). The
performed to assess the significance of the differences in results. The spherical equivalent was significantly higher in Group 1
pupil size, UDVA, and age were analyzed and compared between than in Group 2 (P < .001). In addition, the binocular
the 2 groups using the independent 2-sample t test. A P value of less
than 0.05 was considered statistically significant. UDVA and uncorrected near visual acuity of Group 1 were
A sample size of 55 patients was determined to be sufficient to detect better than that of Group 2 (P < .05) (Table 2).
a medium-to-large effect size (DZ = 0.66) with a 5% significance level
for a 1-tailed test and a 0.8 statistical power (type II error <20%). We Defocus Curve
conducted a sensitivity analysis using GPower 3.1VR. Group 1 attained a superior mean visual acuity of ≥20/25,
within the range of 2.00 to 2.50 D, to that of Group 2
RESULTS (Figure 2). The binocular defocus curve of Group 1
A total of 60 patients (120 eyes) were recruited between demonstrated a higher mean visual acuity at distances of 40
October 4, 2022, and January 20, 2023. However, 2 patients to 50 cm ( 2.00 to 2.50 D) than that of Group 2 (P < .05)
were lost to follow-up, and the study concluded with 58 (Table 3).
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404 BILATERAL SYNERGY AND BLENDED EYHANCE/SYNERGY IOL
DISCUSSION
Pursuing optimal visual correction and patient satisfaction
after cataract surgery drives the advancement and im-
provement of technologies and their effective utilization.
With surgeries now being performed at increasingly
younger ages, the desire for reduced dependence on
spectacles and enhanced visual quality, along with the need
to alleviate nighttime concerns such as halos and glare, has
become paramount. To maintain excellent distant vision
while addressing nocturnal discomfort and liberating pa-
tients from eye spectacles, strategies such as mini mono-
vision have emerged, which uses extended focus lenses.
Although the literature reports favorable outcomes with
Figure 2. Mean defocus curves with the 90% confidence limits at these strategies, they may compromise near vision.1–8
Days 90 and 120 (best-case analysis set). The bilateral Synergy Some studies have analyzed the implantation of an EDOF
group is represented in blue, and the Synergy/Eyhance group is IOL in the dominant eye and a trifocal IOL in the fellow eye,
represented in red. with good results, as an alternative to bilateral trifocal IOL.
QoL Questionnaire Another option is the implantation of a monofocal IOL in the
We reported only the most significant responses because of dominant eye and a trifocal IOL in the nondominant eye. This
the extensive number of questions posed to our patients. combination usually improves contrast sensitivity. However, in
Patients in Group 1 reported higher satisfaction levels some studies, the combination compromises near vision (es-
(completely satisfied) than those in Group 2; the difference pecially the reading speed and near stereopsis). Nevertheless, to
was statistically significant. This information was obtained our knowledge, our study is the first to compare the blended
from the Catquest-9SF questionnaire, where 70% were strategy with the bilateral use of diffractive lenses.3,7–9,31,32
completely satisfied in Group 1 and 21.4% in Group 2. In this study, we used an enhanced monofocal IOL in the
In addition, halos at night and glare were significantly dominant eye and a dual-technology diffractive lens in the
higher in Group 1 than in Group 2 (Supplemental Table 1, fellow eye (in one of the groups). This is because studies
available at http://links.lww.com/JRS/B48). This information show that enhanced monofocal IOLs in both eyes offered
was obtained from the TyPE Spec questionnaire, with 70% equivalent far vision as that offered by monofocal IOLs and
complaining of glare in Group 1 and 39.3% in Group 2. better intermediate and near vision than that offered by
All patients recommended undergoing surgery and monofocal IOLs. However, the use of enhanced monofocal
would readily undergo the procedure again. None of the IOLs in both eyes did not offer spectacle independence as
patients wore spectacles postoperatively. that offered by trifocals or similar diffractive IOLs.1,10–14
In our study, the binocular UDVA was similar in both
Contrast Sensitivity groups across all assessed distances. This implies that both
The contrast sensitivity was comparable between both IOL combinations yielded comparable results regarding
groups under photopic and mesopic conditions, both with distant vision. However, the defocus curve analysis demon-
and without glare (Figure 3). strated a superior mean visual acuity for intermediate
Copyright © 2023 Published by Wolters Kluwer on behalf of ASCRS and ESCRS. Unauthorized reproduction of this article is prohibited.
BILATERAL SYNERGY AND BLENDED EYHANCE/SYNERGY IOL 405
Copyright © 2023 Published by Wolters Kluwer on behalf of ASCRS and ESCRS. Unauthorized reproduction of this article is prohibited.
406 BILATERAL SYNERGY AND BLENDED EYHANCE/SYNERGY IOL
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Disclosures: W.T. Hida is a consultant for Johnson & Johnson
13. Goslings O, Veraart H, van de Laar-Muskens J, Piñero DP. Clinical out- Vision. None of the other authors have any financial or proprietary
comes with an aspheric monofocal and a new enhanced monofocal in- interest in any material or method mentioned.
traocular lens with modified optical profile. Graefes Arch Clin Exp
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Wilson Takashi Hida, MD, PhD
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