Visual Performance and Patient Satisfaction with Multifocal, Monofocal and Monofocal-Plus Intraocular Lenses

doi:10.21203/rs.3.rs-4744087/v1

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Visual Performance and Patient Satisfaction with Multifocal, Monofocal and Monofocal-Plus Intraocular Lenses

https://doi.org/10.21203/rs.3.rs-4744087/v1

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Objective

To evaluate the visual performance and patient satisfaction of three intraocular lenses (IOLs): the newly-designed monofocal-plus Tecnis Eyhance, multifocal Tecnis Synergy, and monofocal Sensar (Johnson & Johnson Surgical Vision©, Inc. Santa Ana, CA, USA).

Methods

This prospective, comparative, interventional study enrolled patients undergoing cataract surgery with implantation of Eyhance, Sensar, or Synergy IOLs. Postoperative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) were assessed at distance (6m), intermediate (70 cm), and near (40 cm) in LogMAR units. Contrast sensitivity (CS) was measured using the Pelli-Robson chart at distance and near vision. Subjective visual comfort was evaluated through a validated questionnaire.

Results

The study included 52 participants (52% females; 84 eyes): 40 eyes with Eyhance, 26 with Synergy, and 18 with Sensar. Ages ranged from 48 to 82 years (mean age 70.2 ± 7.59 years), with 59% female participants. There was no significant difference in distance UCVA among the IOL types (P > 0.8). Synergy showed superior intermediate and near UCVA compared to Eyhance and Sensar (P < 0.01). Eyhance and Sensar demonstrated better distance CS than Synergy (P ≤ 0.05) and better near CS (P < 0.05). Questionnaire responses showed no significant difference in overall visual comfort, but higher satisfaction with intermediate vision was reported for Synergy.

Conclusions

The Synergy lens is recommended for patients prioritizing intermediate and near vision. Eyhance did not show an objective advantage over Sensar for intermediate vision and contrast sensitivity (CS) but had a subjective advantage. Despite reduced CS, Synergy provided excellent distance UCVA, similar to Eyhance and Sensar.

Health sciences/Medical research/Outcomes research

Health sciences/Diseases/Eye diseases/Lens diseases

Cataract

Intra-Ocular Lens

Monofocal

Multifocal

Visual Acuity

Contrast Sensitivity

Cataract remains a leading cause of global blindness, impacting 30% of individuals aged 60–69 and 64% of those over 70.(1) Globally, over 15.5 million cataract surgeries were performed in 2009, and in Israel, 812,112 surgeries occurred between 1990 and 2014.(2) Varied intraocular lens (IOL) designs tailored to individual visual needs, influenced by factors such as work environment and lifestyle.(3) Modern cataract surgery aims to provide excellent uncorrected visual acuity (UCVA) for distance, intermediate, and near vision. Recent advancements in intraocular lenses (IOLs) focus on improving intermediate vision while minimizing visual disturbances such as halos and glare and maintaining contrast sensitivity (CS).(4) The growing use of mobile devices has increased the importance of intermediate vision.

The TECNIS Eyhance IOL (ICB00) is a novel monofocal-plus IOL with enhanced intermediate vision capabilities, designed by Johnson & Johnson Surgical Vision. Its unique anterior surface design claims to provide superior intermediate vision while maintaining image quality and reducing spherical and chromatic aberrations compared to traditional monofocal IOLs.(5, 6)

This study aimed to compare the innovative monofocal-plus Tecnis Eyhance with increased depth of focus IOL, a novel lens design, with other monofocal and multifocal IOLs in terms of visual parameters as visual acuity at different distances, contrast sensitivity and subjective visual comfort.

Participants:

This prospective study was approved by the IRB committee of Hadassah Academic College (study #: 155. June 6th, 2021). Participants received oral and written information about the study aims, methods and signed informed consent form prior their enrollment. All data was anonymized and coded for both clinical examination and questionnaire for statistical analysis.

Participants enrolled in the study were individuals who had undergone cataract surgery in one or both eyes. They were assigned to three groups based on the type of intraocular lens (IOL) implanted: monofocal plus (Eyhance), monofocal (Sensar), or multifocal (Synergy).

Excluded were patients who had cataract surgery less than one month or more than one year prior the recruitment or those with astigmatism > 1.00D against-the-rule (ATR) or 1.50D with-the-rule (WTR) who needed a Toric-IOL lens implantation. Additionally, patients with other ocular diseases or systemic diseases that could impair vision, patients taking medications that could affect dry eyes or VA, patients with severe dry eyes, with amblyopia (VA < 6/12, 0.3 LogMAR, with correction), and patients who did not provide informed consent were not included in this study.

Recruitment:

The study was conducted at a private ophthalmology clinic (A.M) during routine postoperative checkups. Patients who had cataract surgery with the same surgeon (A.M) and were implanted with the Eyhance, Sensar or Synergy IOLs in the past year prior to the enrollment were examined at least one month after the surgery. During this examination, optometrists (T.W, R.M, I.W, D.B) approached the patients to participate in the study. Participation in the study was voluntary and did not affect the patients’ care or treatment. The examiners were blinded to type of IOL that was implanted.

Procedure:

After verifying the inclusion criteria and the type of IOLs implanted, the optometrists performed the following tests: distance UCVA (LogMAR chart at 6 m); intermediate VA (Jaeger test card at 70 cm)(7); near VA (Jaeger test card at 40 cm); subjective refraction and BCVA for distance, intermediate, and near; contrast sensitivity for distance (1 m) and near (40 cm) using Pelli-Robson chart (Precision Vision, Inc. Woodstock, IL, USA); and pupil size using a ruler. Each examiner conducted a full examination on a randomly assigned patient. Additionally, each participant completed a subjective validated questionnaire, the Visual Function Index (VF-14)(8) to assess visual comfort after eye surgery. The questionnaire consisted of 14 Likert scale questions (rated from 0 to 4), which evaluated the participant’s visual needs at different distances and activities. The total score of the VF-14 questionnaire ranged from 0 to 100, with 100 indicating that the answers to all questions were “not difficult at all” and 0 indicating that they were “not possible”. The score was calculated by dividing the sum of answers by the number of questions answered and multiplying by 25.(8) The questionnaire was translated from English to Hebrew back and forth, and the reliability of the translation was checked by a bilingual speaker. Moreover, participants were contacted by phone for three follow-up questions about their satisfaction with their postoperative intermediate vision (Do you have difficulty without glasses reading small letters, as labels on drugs, phone book or food labels? Do you have difficulty without glasses reading a book or newspaper? Do you have a difficulty with intermediate vision- reading musical notes, computer, card games, cooking- without glasses?). Data collected from the medical records of the patients included preoperative medical and ocular history, distance refraction and distance and near BCVA.

Statistical Analysis:

The normality of the data was confirmed using the Kolmogorov-Smirnov test and parametric tests were used for the analysis due to the sufficient sample size. Continuous variables such as age, refraction, VA, contrast sensitivity, pupil size and questionnaire score were presented as mean with standard deviation. A comparison of these variables between the different study groups (Eyhance-Monofocal plus, Synergy-Multifocal and Sensar-Monofocal IOLs), by sex and age groups (40–55 years old, ≥ 56 years old) were performed by the ANOVA and unpaired samples t-tests. The delta between distance VA pre- and post-surgery was analyzed by paired samples t-test. Bonferoni correction was used for post-hoc analysis and multiple comparisons. Spearman test was performed to assess the correlation between VA at different distances and questionnaire score, as well as between refractive results among different pupil sizes. A statistically significant result was considered with α ≤ 0.05 two sided. Statistical analysis was performed using SPSS software (IBM SPSS Statistics, Version 27.0, Chicago. Armonk, NY: IBM Corp).

Power Analysis

A sample size of 84 eyes with expected difference in intermediate uncorrected visual acuity of 0.12 between the Tecnis Eyhance and Tecnis ZCBOO (Mencucci et al,2020 ), with α = 0.05 would yield a power of 89%. (Calculated by G*Power software, version 3.1.9.4)

A total of 52 subjects (84 eyes), 33 had cataract surgery in both eyes, 27 (52%) females, aged between 48–85 years (mean age 69.95 ± 7.90 years) participated in the study. Of these, 40 eyes were implanted with Eyhance monofocal plus IOL, 18 with Sensar-monofocal- and 26 with Synergy- multifocal IOLs. In the Eyhance group, 73% of patients (11/40) were female, in the Synergy group 35% (17/26) and in the Sensar group 67% (6/18). There were no statistically significant differences between men age of the three IOL groups participants. The mean pre- operative best corrected visual acuity (BCVA; LogMAR), and pre- operative spherical equivalent (SE) (Diopter (D)) are presented in Table 1.

Table 1

Baseline characteristics of the study participants
Characteristics	Eyhance N = 40 eyes	Synergy N = 26 eyes	Sensar N = 18 eyes	P
Age) years) Mean ± SD	69.71 ± 0.50	67.00 ± 0.51	74.72 ± 0.51	0.06^a
Age range (years)	55–82	48–85	57–82	NA
Female, N(%)	11(73)	17(35)	6(67)	0.31^b
Pre-operative distance VA (LogMAR) Mean ± SD	0.31 ± 0.17	0.29 ± 0.15	0.32 ± 0.19	0.08^a
Pre-operative SE (Diopter) Mean ± SD	-0.44 ± 2.39	-0.50 ± 3.19	0.24 ± 2.90	0.007^a
^aTested by Kruskal-Wallis test. ^bTested by Chi-Square test. VA = Visual Acuity, SD = standard deviation, SE = spherical equivalent.

Comparing distance, intermediate and near visual acuity (VA) between the three types of IOLs revealed a statistically significant difference in intermediate and near VA between study groups (P < 0.01), but no difference was found in distance VA (P = 0.99). In post-hoc analysis, a statistically significant difference was found in the intermediate and near VA between the Synergy and Eyhance (P < 0.001) and between the Synergy to Sensar (P < 0.001), yet no difference was found between Eyhance and Sensar (P > 0.05). (Table 2)

Table 2 demonstrates the comparison of mean distance VA between the three IOL types. No statistically significant differences were found in distance UCVA between the three IOLs, however, for intermediate and near UCVA, the Synergy was found to be superior compared with Eyhance and Sensar (P < 0.05).

Table 2

Comparison of distance, intermediate and near visual acuities between three Intra-Ocular lenses
	Eyhance N = 40 eyes Mean ± SD	Synergy N = 26 eyes Mean ± SD	Sensar N = 18 eyes Mean ± SD	P^a	P^b
Distance UCVA (LogMAR)	0.06 ± 0.09	0.06 ± 0.08	0.06 ± 0.08	P = 0.99	Eyhance-Synergy P = 0.96
					Synergy -Sensar P = 0.91
					Eyhance - Sensar P = 0.88
Intermediate UCVA (LogMAR)	0.53 ± 0.22	0.29 ± 0.19	0.54 ± 0.12	P < 0.001	Eyhance – Synergy P < 0.01
					Synergy - Sensar P < 0.01
					Eyhance - Sensar P = 0.41
Near UCVA (LogMAR)	0.55 ± 0.30	0.11 ± 0.22	0.56 ± 0.19	P < 0.001	Eyhance - Synergy P < 0.01
					Synergy - Sensar P < 0.01
					Eyhance - Sensar P = 0.19
^aTested by Kruskal-Wallis test and post hoc Bonferroni tests. ^bTested by Mann-Whitney. VA = Visual Acuity, SD = Standard deviation.

Comparison of contrast sensitivity (CS, Log units) between all types of lenses at two distances (1 meter and 40 cm), a statistically significant difference was found between the groups in CS for distance (P < 0.05) and near (P < 0.05). On the post-hoc analysis, no statistically significant difference was found between the groups. (Table 3)

Furthermore, we evaluated the CS ratings for distance uncorrected and near corrected (+ 2.50 ADD) among different IOL types. Sensar exhibited the highest CS (1.45 ± 0.11), followed by Eyhance (1.38 ± 0.15), and Synergy showed the lowest CS (1.31 ± 0.13; P = 0.04). No statistically significant differences were found between Eyhance between Eyhance and Sensar (P = 0.45).

On near CS, a significant difference was found between Eyhance (1.46 ± 0.15) and Synergy (1.36 ± 0.17; P < 0.05), yet between Eyhance (1.46 ± 0.15) and Sensar (1.45 ± 0.13; P = 0.89), and between Sensar (1.45 ± 0.13) to Synergy (1.36 ± 0.17; P = 0.07), no significant difference was found. (Table 3)

Table 3

Comparison between contrast sensitivity (at different distances) and IOL types
	Eyhance N = 40 eyes Mean ± SD	Synergy N = 26 eyes Mean ± SD	Sensar N = 18 eyes Mean ± SD	P ^a	P^b
Distance CS (Log)	1.38 ± 0.15	1.31 ± 0.13	1.45 ± 0.11	P = 0.04	Eyhance – Synergy P = 0.05
					Synergy - Sensar P < 0.01
					Eyhance - Sensar P = 0.45
Near CS (Log)	1.46 ± 0.15	1.36 ± 0.17	1.45 ± 0.13	P = 0.04	Eyhance - Synergy P < 0.05
					Synergy - Sensar P = 0.07
					Eyhance - Sensar P = 0.89
^aTested by Kruskal-Wallis test and post hoc Bonferroni tests. ^bTested by Mann-Whitney. CS = Contrast sensitivity, SD = standard deviation.

When calculating the delta between the distance BCVA pre- and post- surgery, no statistically significant difference between delta of the different IOL types was found (P > 0.05), as well as between VA before surgery vs. after the surgery without correction (UCVA) (P > 0.05).

Subjective questionnaire assessing visual comfort after eye surgery (VF-14) mean score was compared between patients that were implanted with the three types of IOLs. No statistically significant difference was found between mean values of questionnaire score By IOL type (P = 0.13). (Fig. 1)

Analyzing the correlation between the questionnaire score to VA and CS at different distances revealed a weak yet not statistically significant negative correlation between VA on different distances and mean score of the questionnaire; distance VA (R=-0.14, P = 0.20), intermediate VA (R=-0.13, P = 0.25), and near VA (R=-0.07, P = 0.54).

However, correlation between CS to mean score of VF-14 questionnaire was found to be weak yet statistically significant positive; distance CS (R = 0.29, P < 0.01) and near CS (R = 0.26, P < 0.05) to questionnaire score.

When selecting questions from the questionnaire that addresses intermediate uncorrected vision to assess differences in visual comfort by intraocular lens (IOL) type, a statistically significant difference was found. The Synergy IOL demonstrated the highest satisfaction for intermediate uncorrected vision (4.0 ± 0). Patients implanted with the Eyhance IOL reported lower satisfaction for intermediate uncorrected vision (3.06 ± 1.34) compared to the Synergy, but it was higher than the satisfaction reported by Sensar patients, who had the lowest satisfaction for intermediate uncorrected vision (2.20 ± 0.79; P < 0.01) (Fig. 2).

During the past decade there has been an ongoing effort to improve the technology and IOL designs to provide the best visual performance at all distances for every patient undergoing cataract surgery. This study aimed to compare the quality of vision and patient satisfaction after cataract surgery with three different types of intraocular lenses (IOLs): the monofocal-plus Eyhance IOL, the monofocal Sensar IOL, and the multifocal Synergy IOL. The Eyhance IOL is a novel monofocal IOL with a modified aspheric anterior surface and a continuous power gradient from the periphery to the center of the lens, which is designed to improve intermediate vision, reduce spherical aberrations, and avoid the drawbacks of multifocal IOLs, such as night halos and glare.(9)

One of the main outcome measures of this study was the distance visual acuity (VA), which showed no significant differences among the three IOLs. This indicates that the preoperative target refraction and the postoperative residual refraction were well matched for all three IOLs. Moreover, the mean change in distance VA before and after surgery was similar for all three IOLs. These results are consistent with those of Cinar et al (2020), who compared the postoperative VA between the Eyhance IOL and a monofocal IOL (SN60WF IQ AcrySof, Alcon) and found no significant differences in corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), or corrected near visual acuity (CNVA) between the two groups.

Previous studies on the Eyhance IOL focused on its intermediate performance and used small sample sizes.(5, 6, 10–12) No comprehensive evaluation of this lens and its comparison with other IOLs has been conducted. We hypothesized that the Eyhance lens would provide superior visual parameters and subjective comfort than other lenses and eliminate the need for intermediate correction.

Another main outcome measure of this study were the intermediate and near VA. The multifocal Synergy IOL showed superior performance in intermediate and near VA compared with the two monofocal IOLs, which is expected given its design to provide a continuous range of vision from far to near. The Eyhance IOL, on the other hand, showed similar performance to the Sensar IOL in intermediate and near VA, which is contrary to some previous studies that reported better intermediate VA with the Eyhance IOL than with other monofocal IOLs.(9, 11) A possible explanation for this discrepancy could be the different methods of measuring intermediate VA, the different definitions of intermediate distance, or the different inclusion and exclusion criteria of the studies. For example, Jeon and colleagues compared the extended depth of focus (EDOF) ZXR00 Symphony IOL with the Eyhance IOL and found no significant differences in UCDVA, CDVA, or uncorrected intermediate visual acuity (UIVA) between the two groups, but a significant difference in uncorrected near visual acuity (UNVA) in favour of the Symphony IOL.(13)

Rocha and coworkers compared the spherical AcrySof SN60AT IOL, the aspheric AcrySof IQ IOL, and the spherical Sensar AR40 IOL on 40 eyes and found no significant differences in distance VA among the three groups, but significant differences in distance corrected intermediate acuity (DCIVA) and distance corrected near acuity (DCNVA) in favor of the AcrySof SN60AT IOL (P < 0.05).(14)

A secondary outcome measure of this study was the contrast sensitivity (CS) of the patients implanted with the three different types of IOLs. The results showed that the Eyhance IOL had better CS than the Synergy IOL at both distance and near vision, which could be explained by the different designs of the two IOLs. The Synergy IOL has a concentric ring design that splits the light into two foci, which may reduce the CS and cause visual disturbances, such as dysphotopsia - halos, and glare.(15) The Eyhance IOL has a modified aspheric anterior surface and a continuous power gradient that extends the depth of focus, which may improve the CS and avoid the drawbacks of the multifocal IOLs.(6) This suggests that the Eyhance IOL may be a better option for patients who are sensitive to halos or glare or who have high visual demands. These results are consistent with those of Unsal and Sabur, who found no difference in photopic CS for any spatial frequency between the Eyhance IOL and a monofocal IOL (Tecnis 1-piece).(10) However, there are no studies that directly compare the CS between the Eyhance IOL and the multifocal IOLs, which limits the generalizability of our findings.

Our findings are in line with a previous study by Kim and colleagues from 2007, who also reported lower CS in the multifocal group than in the monofocal group. Our study confirms that multifocal IOLs may compromise the quality of vision in terms of CS, which is an important factor for visual function and satisfaction.(16) Therefore, careful selection of IOLs based on the individual needs and preferences of patients is essential to optimize their postoperative outcomes.

Sensar is a conventional monofocal IOL that does not split the light into multiple foci, while Synergy is a multifocal IOL that provides a continuous range of vision. We found that the CS of the Sensar IOL was comparable to that of the Synergy IOL at both distance and near vision. This finding was unexpected, as we hypothesized that the Synergy IOL would have lower CS due to the light-splitting effect. A possible explanation for this finding could be the influence of the different materials or optical properties of the two IOLs on the CS. For instance, Kim et al reported that the CS of patients who received a multifocal silicone IOL (Array SA40N) was significantly lower than that of patients who received a monofocal silicone IOL (SI40NB) across all spatial frequencies tested (p < 0.01).(16) This result is consistent with our finding that the multifocal group had lower CS than the monofocal group. However, Kim et al used different types of IOLs than we did, which may have different impacts on the CS. Therefore, more research is required to compare the CS of the Sensar IOL and the Synergy IOL with other types of IOLs.

We also evaluated the patient satisfaction with the outcomes of the surgery as a third outcome measure. We found no correlation between VA, CS and patients’ subjective visual satisfaction, nor any significant difference in overall visual comfort among the three IOLs. However, patients who received the Synergy IOL reported higher subjective quality of vision at intermediate than those who received the other two IOLs. This result is in line with a recent study by Tanabe et al., who showed greater satisfaction with the multifocal IOL than with the monofocal IOL.(17) Another study by Wilkins et al conducted a randomized trial in 2013, where they compared the Tecnis ZM900 diffractive multifocal IOL (Abbott Medical Optics) with the Akreos AO monofocal IOL (Bausch & Lomb, Ltd) targeted for monovision. They reported no significant difference in satisfaction between the groups (85% satisfied with monovision and 81% satisfied with multifocal; P = 0.46), which is similar to our finding, except that they found higher satisfaction with the multifocal lens for intermediate tasks.(18)

One of the limitations of our study is the sample size, which was determined by a power analysis to be sufficient. We used a validated subjective questionnaire that had some limitations regarding our research questions. The questionnaire did not include any questions regarding intermediate range, which is crucial for assessing this type of IOL. We addressed this limitation by adding three questions about intermediate vision to the questionnaire. Another potential limitation of our study could be affiliation bias, since the participants were recruited from a private clinic of one surgeon and may have similar baseline characteristics. However, this could bias the results towards the null hypothesis. The fact that all participants in our study underwent their surgery with the same surgeon is also an advantage, as it eliminates the variability in the visual outcomes of the patients that could be attributed to different surgeons. The main strength of our study is the comparison of the three lenses- monofocal Sensar, newly-designed monofocal Eyhance and multifocal Synergy- with multiple visual outcomes and patient satisfaction.

The newly-designed monofocal-plus Eyhance IOL with increased depth of focus outperformed the monofocal Sensar and the multifocal Synergy IOL in CS, and was comparable to the monofocal Sensar IOL in intermediate vision. The Eyhance IOL can reduce the haloes and glare that are associated with poor CS. Clinicians can use these findings to recommend the monofocal Eyhance IOL to patients who are not suitable for multifocal IOL implantation or who experience severe symptoms of haloes, glare and loss of contrast sensitivity, such as professional drivers.

Conflict of Interest:

The authors declare no financial disclosures in this study.

Ethical Approval

The study was approved and performed in accordance with the institutional IRB Committee (of Hadassah Academic College (study #: 155. June 6th, 2021). Participants received oral and written information about the study aims, methods and signed informed consent form prior their enrollment. All data was anonymized and coded for both clinical examination and questionnaire for statistical analysis. This study was performed in accordance with the Helsinki Declaration of 1964, and its later amendments.

Funding:

This study received no funding.

Acknowledgment:

The authors thank all the participants in this study, and Mrs. Dinah Paritzky for proof reading.

Data Availability:

Data are available on reasonable request.

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Visual Performance and Patient Satisfaction with Multifocal, Monofocal and Monofocal-Plus Intraocular Lenses

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Abstract

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Introduction

Materials and Methods

Participants:

Recruitment:

Procedure:

Statistical Analysis:

Power Analysis

Results

Discussion

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Ethical Approval

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References

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