Cataract surgery with new monofocal intraocular lens enhanced for intermediate vision and standard monofocal intraocular lens for retinal disorder

doi:10.21203/rs.3.rs-2622611/v1

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Cataract surgery with new monofocal intraocular lens enhanced for intermediate vision and standard monofocal intraocular lens for retinal disorder

https://doi.org/10.21203/rs.3.rs-2622611/v1

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AIM

To investigate the difference in the initial surgical results between a new monofocal intraocular lens (IOL) with enhanced intermediate vision and the standard monofocal IOL in patients with retinal disease.

METHODS

We retrospectively reviewed the medical records of patients with retinal disease who underwent cataract surgery due to accompanying cataracts. Preoperative best corrected distant visual acuity, spherical equivalent(SE), and types of retinal diseases were investigated. The surgical results were investigated using uncorrected visual acuity(UCVA) and SE at 1 day, 1 week, and 1 month after surgery.

RESUTLS

Seventeen eyes treated with a new monofocal IOL enhanced for intermediate vision (ICB00 group) and 18 eyes treated with the standard monofocal IOL (AAB00 group) were included in this study. There were no significant differences in the baseline characteristics, including the type of underlying retinal disease, between the groups. There were no significant differences between the groups in terms of distant, intermediate, or near UCVA at day 1 and week 1 after surgery. However, at 1 month after surgery, the ICB00 group showed a significantly better intermediate vision improvement than the AAB00 group (p = 0.001).

CONCLUSION

Even in patients with cataract accompanied by retinal disease, the use of the ICB00 IOL showed significant improvement in intermediate vision compared to the use of the AAB00 (standard monofocal) IOL. The ICB00 IOL might be a good option for patients with cataract and retinal disease in the era of increased intermediate vision needs in daily life.

Cataract surgery

Monofocal intraocular lens

Intermediate vision

Retinal disorder.

Cataract surgery is the most commonly performed surgery in developed countries to improve vision.¹ Owing to the development of various types of intraocular lenses (IOLs), cataract surgery has become a refractive surgery rather than a surgery for just replacing the opaque crystalline lens.²

The standard monofocal IOL is widely used because of its excellent outcomes in far vision and the low incidence of photic phenomena such as halo or glare.³ However, since the monofocal IOL is only focused on only one visual distance, its application for improving near-to-intermediate vision is limited. In particular, owing to the increased usage of handheld devices, smartphones, and computers with the development of modern technology, the time spent on using near to intermediate vision has increasing.^{4, 5} Therefore, patients who received monofocal IOL implantation had no choice but to use progressive glasses or near vision glasses or monovision through binocular cataract surgery to improve near to intermediate vision.

In recent years, due to the increasing demand for near-to-intermediate distance vision, it has become more and more common to correct presbyopia during cataract surgery.⁶ However, the early multifocal IOL developed for improving presbyopia had limitations in improving intermediate vision.^3,7,8 Moreover, the importance of intermediate vision has been increasing in modern daily life as it is used when viewing a tablet, computer monitor, or car dashboard and performing sports activity.⁹ Therefore, multifocal IOL based on diffractive technology have been developed to improve intermediate vision. However, the presence of a diffractive ring increases the occurrence of unwanted photic phenomena, such as halo or glare, which eventually become a problem for patient selection.^{10, 11}

Subsequently, a new monofocal IOL, Tecnis Eyhance ICB00 (Johnson & Johnson Vision, Santa Ana, CA, USA), was developed to overcome these issues. The new monofocal IOL with a refractive surface design is known to slightly increase the depth of focus compared to the standard monofocal IOL. Recent studies have shown that the new monofocal IOL not only provides reasonable distant vision, but also strengthens intermediate vision.^{2, 6}

This new monofocal IOL, ICB00, is expected to show good results in patients with and without underlying ophthalmic diseases such as retinal disease. However, no studies have been conducted on cataract patients with other concomitant ophthalmic diseases. Therefore, this study aimed to investigate whether the new monofocal IOL would be advantageous over the standard monofocal IOL in intermediate vision after cataract surgery in patients with retinal disease.

We retrospectively reviewed the medical records of patients with retinal disease who underwent cataract surgery at OO Hospital between October and December 2020. This study was approved by the Institutional Review Board and followed the tenets of the Declaration of Helsinki (No.: 2021-06-016)

Patients aged > 40 years with retinal disease who required cataract surgery and were followed up for > 1 month after cataract surgery were included. The exclusion criteria were corneal astigmatism of > 1 diopter, intraoperative or postoperative complications, high myopia (> 8 diopters), glaucoma, media opacities due to corneal disease, history of ocular trauma or intraocular surgery, and retinal status in which vision improvement could not be expected by cataract surgery. One eye of patients who met the inclusion criteria for both eyes were randomly selected.

Ophthalmic examinations

Ophthalmologic examination was performed before surgery and at 1 day, 1 week, and 1 month postoperatively. During each visit, ophthalmic examinations including best corrected distant visual acuity (BCDVA) measurements, Goldman applanation tonometry, slit lamp examination, fundus photography, and spectral domain optical coherence tomography (Spectralis, Heidelberg Engineering, Heidelberg, Germany) were performed. Objective and subjective refraction tests were performed, and distant uncorrected visual acuity (UCVA) at 4 m, intermediate UCVA at 70 cm, near UCVA at 35 cm, and BCDVA at 4 m were recorded at each visit. The visual acuity was measured under standard room illumination of 500 lux using a Snellen optotype for distance vision and a Parinaud optotype for near vision. The intermediate VA was assessed with a decimal scale at 70 cm with a near optotype calibrated for 35 cm. The BCDVA and UCVA results were converted to logMAR scales. Optical biometry was performed using an AL scan (Nidek, Gamagori, Japan), and the SRK/T formula was used to apply a constant A of 119.3 to both IOLs.

Intraocular lens

Both monofocal IOLs are from the same manufacturer (Johnson Vision). Both IOLs have the same optic diameter of 6.0 mm and same shape as that of a biconvex monofocal one-piece lens. Regarding the anterior surface, AAB00 has a spherical design and ICB00 has a modified aspheric design. The materials, refractive index, edge design, overall diameter, haptic style, and design of both IOLs are the same.¹²²¹² In all patients, target refractive error after cataract surgery was emmetropia.

Surgical procedures

Before the procedure, the patients underwent topical mydriasis, induction of topical anesthesia, standard sterile draping, and speculum insertion. All main clear corneal insertions were made along the steep axis with a width of 2.75 mm. The capsulorhexis was approximately 5.2 mm in diameter, and standard phacoemulsification was performed. In all patients, the IOL was implanted in the capsular bag. The incisions were closed using stromal hydration. The postoperative regimen included gatifloxacin (Gariflo®, Samil, Seoul, South Korea), administered four times daily, and dexamethasone (Maxidex®, Norvartis, Basel, Switzerland), administered four times a day for 1 month.

Statistical analysis

Statistical analyses were performed using Statistical Package for the Social Sciences software (version 22.0; SPSS, Chicago, IL, USA). Probability values of P < 0.05 were considered indicative of statistical significance. An independent t test was used to compare continuous variables between the groups, and a Pearson’s chi-square test was used to compare the categorical variables between the two groups. Except where stated otherwise, the data are presented as mean ± standard deviation value. The statistical program G*Power 3.1.2 (Franz Faul, University Kiel, Germany) was used to ascertain which sample size was sufficient over an independent t test. A total sample size of n = 40 (sample size of n = 18 for group 1 and sample size of n = 22 for group 2) was found to be sufficient for the power (1-β) of 0.95, effect size 1.17, actual power 0.95.

In total, 40 patients were included—18 eyes received a new monofocal IOL enhanced for intermediate vision (ICB00 group) and 22 eyes received the standard monofocal IOL (AAB00 group). There were no significant differences in age, sex, baseline spherical equivalent (SE), corneal astigmatism, axial length, and baseline BCDVA between the groups (Table 1).

Table 1

Comparison of characteristics according to IOL types
	ICB00	AAB00	P-value
Number of Patients (n)	18	22
Age (years)	67.0 ± 10.2	69.9 ± 10.5	0.390^*
Male/Female (n/n)	7/11	9/13	0.900^#
Right/Left (n/n)	9/9	9/13	0.577^#
Baseline SE (Diopters)	-1.29 ± 4.13	-0.95 ± 3.15	0.771^*
Corneal Astigmatism (Diopters)	-0.67 ± 0.47	-0.74 ± 0.45	0.613^*
Axial Length (mm)	23.64 ± 1.14	23.56 ± 0.76	0.793^*
Baseline BCDVA (logMAR)	0.77 ± 0.46	0.61 ± 0.39	0.243^*
SE, Spherical equivalent; BCDVA, Best corrected distant visual acuity
^*Independent t test
^#Pearson chi square test

Comparison of retinal disorders according to IOL types

Regarding underlying retinal disease, age-related macular degeneration (AMD) was observed in two and three patients in the ICB00 and AAB00 groups, respectively. All AMD patients were early AMD patients according to the Wisconsin Age-Related Maculopathy Grading System.¹³ Branch retinal vein occlusion with macular edema was observed in one and two patients the ICB00 and AAB00 groups, respectively. Seven and 10 patients with diabetic retinopathy did not receive panretinal photocoagulation in the ICB00 and AAB00 groups, respectively, and two patients in each group received laser treatment. There were no macular lesions in all DR patients.¹⁴ In each group, three patients had epiretinal membranes (ERM) and one patient had a history of macular hole surgery. All enrolled ERM grades were Govetto stage 2¹⁴ and all macular hole grades were of Gass stage 2.¹⁵

Two patients and one patient the ICB00 and AAB00 groups, respectively, had a history of vitrectomy for rhegmatogenous retinal detachment. (Table 2).

Table 2

Comparison of retinal disorders according to IOL types
	ICB00	AAB00
Age-related macular degeneration (n)	2	3
BRVO with Macular Edema (n)	1	2
Diabetic retinopathy (PRP not done) (n)	7	10
Diabetic retinopathy (PRP done) (n)	2	2
Epiretinal membrane (n), Stage 1 / 2	1 / 2	1 / 2
Macular hole (n), Stage 2	1	1
History of RRD s/p vitrectomy (n)	2	1
BRVO, Branch retinal vein occlusion: PRP, Panrtetinal photocoagulation; RRD, Rhegmatogenous retinal detachment

Comparison of visual outcome according to IOL types

The average IOL power in the ICB00 and AAB00 groups was 20.92 ± 2.69 and 20.57 ± 2.30 diopters, respectively. There was no significant difference in the IOL power between the groups. The 1-month postoperative SE was compared and there was no significant difference between the groups after surgery (Table 3).

Table 3

Comparison of surgical outcomes according to IOL types
	ICB00	AAB00	P-value
IOL powers (Diopters)	20.92 ± 2.69	20.57 ± 2.30	0.130^*
Post-operative SE (Diopters)	-0.46 ± 0.45	-0.55 ± 0.45	0.664^*
SE, Spherical equivalent;
*Indepen0dent t test000000

In the case of distant UCVA after surgery, distant visual acuity improved after surgery compared to preoperative BCDVA over time. However, there were no significant differences between the groups at all time points (Fig. 1A). Figure 2 shows a standard graph for reporting refractive outcomes for intraocular lens-based procedure in a cataract surgery.¹⁶ There was no difference in postoperative BCDVA between the two groups (Fig. 2A), and there was no difference in BCDVA and distant UCVA between the two groups (Fig. 2B). Postoperative spherical equivalents or refractive cylinders also showed no difference between the two groups (Fig. 2C, 2D).

Intermediate UCVA improved after surgery compared to preoperative BCDVA in both groups. At day 1 and week 1 after surgery, there was no significant difference between the groups in terms of intermediate UCVA. At 1 month after surgery, however, the ICB00 group had significantly better intermediate UCVA (0.17 ± 0.14) than the AAB00 group (0.41 ± 0.22) (P = 0.006, Fig. 1B). There was no significant difference between the groups at all time points in terms of near UCVA (Fig. 1C). After cataract surgery with ICBOO and AABOO IOL, no patients experience photic phenomenon such as halo and glare.

In this study, we investigated the visual outcomes of ICB00, a newly developed monofocal IOL with an extended depth of focus, and those of the standard monofocal IOL 1 month after cataract surgery in patients with retinal disease. According to this study, when using ICB00, even in patients with cataract and retinal disease, intermediate vision was significantly improved compared to that with the standard monofocal IOL from a relatively early time point of 1 month after surgery. In addition, there was no impairment in distant vision improvement compared to that with the standard monofocal IOL.

The importance of intermediate distance vision can be easily overlooked; however, from the patient's point of view, intermediate distance visual acuity is considered very important for daily life. Numerous instances of modern everyday life involve intermediate vision, such as viewing a tablet, computer monitor, or car dashboard or performing sports activity.⁹ Therefore, in modern daily life, where these activities have been increasingly performed, patients’ demands for intermediate vision after cataract surgery have also been increasing.

ICB00, which was recently developed to improve intermediate vision, extends the depth of focus of refractive IOL that uses a modified aspheric design to increase negative aberration and achieve a larger depth of focus compared to the standard monofocal IOL.¹⁷ This modified aspheric design creates a continuous power profile (the power increases continuously from the periphery to the center of the lens), which extends the depth of focus, thus improving vision for intermediate tasks. This unique anterior surface and a thickness difference of 1.5 microns with a diameter of nearly 2 mm in the optical center increases the power by 0.5 D.¹⁸ Furthermore, it is based on the refractive technology, without diffractive rings and without zones.⁶ With this theoretical background, ICB00 has been evaluated as an IOL for cataract surgery suitable for the living environment of modern people in a number of previous clinical studies.^{2, 6, 19–21} In our study, we compared this ICB00 with AAB00 (standard monofocal) IOL in cataract patients with retinal disorders. These two types of IOLs are biconvex monofocal one-piece IOLs from the same manufacturer. The have the same overall diameter, optic diameter, materials, refractive index, edge design, and haptic style, except the anterior surface design.¹²

Currently, it is accepted without controversy that cataract surgery using the standard monofocal IOL helps improve visual acuity in patients with retinal diseases such as maculopathy and diabetic retinopathy.²² However, a multifocal IOL is contraindicated in patients with several retinal diseases that have already reduced contrast sensitivity, especially maculopathy, diabetic retinopathy, and retinal dystrophy, because there is an additional decrease in contrast sensitivity after cataract surgery with a multifocal IOL.²³ Further, in the case of multifocal IOL, when IOL decentration occurs, high-order aberration increases and objective contrast discrimination diminishes.²⁴ Additionally, multifocal IOL may cause a photic phenomenon, which may cause a major problem in image quality in patients with retinal disease.^25–27 Therefore, patients with retinal disease did not have a suitable alternative to improve their near-to-intermediate vision after cataract surgery in an era when near-to-intermediate vision is important. However, the newly developed ICB00 has a monofocal design with no demarcation line, and it is theoretically considered that the decrease in contrast sensitivity, increase in spherical aberration, and occurrence of photic phenomenon are less with this IOL than the multifocal IOL, and such results have been reported in several clinical studies.^{19, 28} Therefore, ICB00 is expected to be widely used in patients with cataract and other ophthalmic diseases, including retinal disease.

It is important to identify whether there is any deterioration in distance vision when using ICB00 compared to using standard monofocal IOL during cataract surgery in patients with retinal disease. All previous studies included patients with only cataract without other ophthalmic disease.^{2, 19–21} In this study on patients with retinal disease, ICB00 was not different from the standard monofocal IOL in terms of distant vision, but showed better results in terms of intermediate vision. These results suggest that patients with cataract and retinal disease can also expect to benefit from an improved quality of life through the improvement of intermediate vision. Along with distant and intermediate visual acuity improvement after surgery, there was no photic phenomenon such as halo and glare in cataract patients with retinal disorder.

The strength of our study is that it is the first study to investigate the effect of monofocal IOL enhanced for intermediate vision in patients with cataract and other ophthalmic diseases. However, our study has the following limitations. (1) The present study has a retrospective design with selection bias as well as a small number of subjects. In addition, 7 different types of retinal lesions were analyzed together, so caution is needed in interpreting the results. (2) This study did not investigate the subjective satisfaction⁶ of patients after surgery. (3) Before and after surgery, pupil size, contrast sensitivity, high-order aberration, and visual quality other than visual acuity could not be evaluated because of the lack of related instrument. For more accurate results, a prospective study with longer observation period and large number of participants evaluating optical quality and patient satisfaction is warranted.

In conclusion, in this study on patients with cataract and retinal disease, ICB00, a newly developed monofocal IOL with an extended depth of focus, showed better intermediate visual acuity results, with no difference in distant vision, than the standard monofocal IOL. Although the use of ICB00 may have limitations in near vision, it is expected to be of great benefit to patients with retinal diseases who want to improve their vision through cataract surgery by enhancing intermediate vision, which is widely used in modern life. If the indications of ICB00 can be widened through additional studies, it will help to increase the quality of life of patients with retinal diseases.

Ethics approval and consent to participate

This retrospective observational study was approved by institutional review board of Chungbuk National University Hospital (No.: 2021-06-016). The institutional review board of Chungbuk National University Hospital waived the need for informed consent due to the deidentified data handling and the retrospective nature of the study.

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

Competing interests

None

Funding

There was no specific funding or financial support for this study.

Authors' contributions

The author contributions were as follows: design of the study (HH and DK); collection and management of the data (HH, HL and DK); analysis and interpretation of the data (HH, HL, JC and DK); preparation of the manuscript, and statistical analysis and interpretation (HH, HL, JP, JC and DK); review and approval of the manuscript (HH, HL, JP, JC and DK).

Acknowledgements

None

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No competing interests reported.

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Version 1

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You are reading this latest preprint version

Cataract surgery with new monofocal intraocular lens enhanced for intermediate vision and standard monofocal intraocular lens for retinal disorder

Status:

Version 1

Abstract

AIM

METHODS

RESUTLS

CONCLUSION

Figures

Introduction

Patients And Methods

Ophthalmic examinations

Intraocular lens

Surgical procedures

Statistical analysis

Results

Comparison of retinal disorders according to IOL types

Comparison of visual outcome according to IOL types

Discussion

Declarations

References

Additional Declarations

Status:

Version 1