Monofocal intraocular lenses with enhanced intermediate function provide more satisfaction in phaco-vitrectomy for the epiretinal membrane and cataracts

doi:10.21203/rs.3.rs-4812019/v1

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Monofocal intraocular lenses with enhanced intermediate function provide more satisfaction in phaco-vitrectomy for the epiretinal membrane and cataracts

https://doi.org/10.21203/rs.3.rs-4812019/v1

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A newly developed monofocal intraocular lens (IOL), known as Eyhance, features a continuously increasing refractive power from the periphery to the center of the lens, aiming to enhance intermediate vision. Our multicenter prospective, nonrandomized, comparative study in Japan aimed to compare the outcomes of phaco-vitrectomy for epiretinal membrane (ERM) and cataracts using Eyhance (DIB00V) versus a conventional monofocal intraocular lens (DCB00V). Sixty-two eyes implanted with Tecnis-1 and 79 eyes with Eyhance were analyzed. While there was no significant improvement in distance-corrected intermediate visual acuity with Eyhance (0.35 in logMAR) compared to DCB00V (0.39 in logMAR, p = 0.200), Rasch analysis of patient-reported outcomes using the Japanese modified Catquest-9SF Questionnaire revealed that Eyhance scored higher in patient general satisfaction (p = 0.0269). Subgroup analysis revealed a trend toward better postoperative distance-corrected intermediate visual acuity in patients with a certain degree of postoperative myopia. In conclusion, Eyhance may not provide superior immediate vision in phaco-vitrectomy for ERM compared to the conventional monofocal IOL, but it is not inferior. Furthermore, Eyhance could enhance postoperative satisfaction in patients with ERM and cataracts.

Health sciences/Diseases/Eye diseases/Retinal diseases

Health sciences/Diseases/Eye diseases/Lens diseases

epiretinal membrane

Eyhance intraocular lens

patient-reported outcomes

Rasch analysis

intermediate visual acuity

Japanese modified Catquest-9SF Questionnaire

Epiretinal membrane (ERM) is a condition affecting about 7–8% of the population, leading to reduced visual acuity and metamorphopsia¹. Vitrectomy is often necessary to prevent irreversible vision loss, and in cases where cataracts are present or expected to worsen, combined phaco-vitrectomy surgery is performed¹. In eyes with macular diseases affecting macular function, multifocal lenses may not be recommended, and monofocal intraocular lenses (IOLs) are typically used in combined surgery². However, there is a growing demand for vision correction at various distances, which can be challenging to achieve with a monofocal IOL³.

In cataract surgery, multifocal IOLs have been shown to improve both near and distance visual acuity compared to monofocal IOLs⁴. However, they are associated with more common issues like contrast sensitivity loss and photic phenomena such as glare and halos than with monofocal lenses⁴. Tecnis® Eyhance™ Optiblue (DIB00V) is a new type of aspheric monofocal IOL developed by Johnson & Johnson Vision (Santa Ana, CA). It features a continuous change in refractive power from the periphery to the center of the lens while maintaining the same material and size as the company’s conventional monofocal IOL, Tecnis® 1-piece Optiblue (DCB00V)⁵. This design aims to increase the depth of focus and improve intermediate vision while preserving distance vision. Several retrospective studies and randomized controlled trials have shown that these enhanced monofocal IOLs maintain distance vision and provide significantly better intermediate visual acuity compared to conventional monofocal IOLs in cataract surgery^6–15. However, there are conflicting reports in some studies^16–19.

In recent years, there has been a growing emphasis on patient-reported outcomes (PROMs) and visual acuity following cataract surgery, with studies analyzing questionnaires assessing the quality of vision^8,9,15,16. Responses to these questionnaires are often assigned ordinal numerical scores, which cannot be analyzed linearly due to the lack of an interval scale. In this case, Rasch analysis is used to convert these scores into a linear interval scale, enabling linear parametric analysis and validation of the results²⁰.

A recent clinical study on the use of Eyhance for cataract surgery in eyes with ERM has demonstrated that the lenses provided relatively good distance and intermediate vision with minimal discomfort or complications²¹. However, studies comparing postoperative visual function and PROMs between conventional monofocal IOLs and Eyhance in combined cataract and ERM surgery using validated assessment methods are limited.

This study aimed to compare the clinical outcomes of combined surgery for ERM and cataract, focusing on best-corrected distance visual acuity (BCDVA), distance-corrected intermediate visual acuity (DCIVA), and PROMs, using the Tecnis® Eyhance Optiblue (DIB00V; Eyhance) and Tecnis® 1-piece Optiblue (DCB00V; Tecnis-1).

Patient background

A total of 151 eyes from 131 patients were included in this study. Twenty patients underwent combined surgery for ERM and cataracts in both eyes. Two patients who had surgery on both eyes missed the 3-month follow-up of one eye, and six patients who had surgery on one eye missed the 3-month follow-up. One patient was excluded due to corneal irregular astigmatism, and another patient was excluded due to branch retinal vein occlusion. Ultimately, 141 eyes from 123 patients were analyzed. Sixty-two eyes were implanted with Tecnis-1, and 79 eyes were implanted with Eyhance. The mean age of the patients was 71 years, with 48% male and 52% female. The demographic and clinical characteristics of the patients in each IOL group at the preoperative visit are summarized in Table 1. There were no significant differences in these characteristics between the Tecnis-1 and Eyhance groups.

Table 1

Summary of preoperative clinical data overall and in the two intraocular lens (IOL) groups. The corresponding p-values for the comparison between the two IOL groups are shown for each parameter evaluated.
Mean (SD)	Overall, n = 141	Tecnis-1, n = 62	Eyhance, n = 79	P-value
Age (years)	71 (9)	71 (9)	71 (8)	0.715*
Gender (male/female)	73/68	34/28	39/40	0.611**
UCDVA logMAR	0.78 (0.43)	0.84 (0.45)	0.73 (0.40)	0.166*
BCDVA logMAR	0.27 (0.27)	0.27 (0.29)	0.26 (0.27)	0.977*
Sphere (D)	−1.4 (3.6)	−1.8 (3.4)	−1.1 (− 3.7)	0.292*
Cylinder (D)	−0.73 (1.17)	−0.78 (1.16)	−0.69 (1.18)	0.675*
Corneal astigmatism (D)	−0.81 (0.48)	−0.9 (0.57)	−0.74 (0.38)	0.055*
Pupil diameter (mm)	3.14 (0.68)	3.14 (0.66)	3.15 (0.70)	0.934*
IOP (mmHg)	14.56 (2.75)	14.73 (2.47)	14.13 (2.95)	0.502*
CMT (µm)	402 (85)	411 (83)	395 (87)	0.259*
* Welch two-sample t-test
** Fisher’s exact test

BCDVA, best-corrected distance visual acuity; CMT, central macular thickness; Cylinder, cylindrical error; D, diopter; IOP, intraocular pressure; logMAR, logarithmic minimum angle of resolution; SD, standard deviation; Sphere, spherical error; UCDVA, uncorrected distance visual acuity

Outcomes at 3-month visits

Visual acuity and other measurements at the 3-month postoperative visit are summarized in Table 2. The total operative time and macular manipulation time are presented in Table 3. The mean logarithmic minimum angle of resolution (logMAR) for DCIVA was 0.39 for the Tecnis-1 group and 0.35 for the Eyhance group, with no significant difference (p = 0.200). The mean logMAR for BCDVA was 0.05 for the Tecnis-1 group and 0.09 for the Eyhance group, with no significant difference (p = 0.174). Uncorrected distance visual acuity (UCDVA) tended to be better in the Eyhance group, with 0.48 in the Tecnis-1 group and 0.37 in the Eyhance group, but this difference was not statistically significant (p = 0.060). Uncorrected intermediate visual acuity (UCIVA) tended to be better in the Eyhance group (0.30 in logMAR) than in the Tecnis-1 group (0.38 in logMAR), but this difference was not significant (p = 0.051). There were no significant differences in other parameters at the 3-month visit between the two groups. Postoperative central macular thickness (CMT) was significantly reduced compared to preoperative CMT in the Tecnis-1 group, while in the Eyhance group, postoperative CMT did not show a significant reduction (Supplementary Table 1). The total operative time and macular manipulation time were 25 and 6.26 minutes overall, 26 and 6.38 minutes in the Tecnis-1 group, and 25 and 6.16 minutes in the Eyhance group, respectively, with no significant differences.

Table 2

Summary of 3-month postoperative clinical data overall and in the two intraocular lens (IOL) groups. The corresponding p-values for the comparison between the two IOL groups are shown for each parameter evaluated.
Mean (SD)	Overall, n = 141	Tecnis-1, n = 62	Eyhance, n = 79	P-value
UCDVA logMAR	0.42 (0.35)	0.48 (0.38)	0.37 (0.32)	0.060*
UCIVA logMAR	0.33 (0.24)	0.38 (0.22)	0.30 (0.25)	0.051*
BCDVA logMAR	0.07 (0.18)	0.05 (0.11)	0.09 (0.22)	0.174*
DCIVA logMAR	0.37 (0.20)	0.39 (0.15)	0.35 (0.23)	0.200*
Sphere (D)	−0.63 (1.06)	−0.83 (1.21)	−0.48 (− 0.90)	0.068*
Cylinder (D)	−0.92 (0.58)	−0.93 (0.62)	−0.91 (0.55)	0.916*
Pupil diameter (mm)	3.08 (0.67)	3.15 (0.77)	3.01 (0.57)	0.232*
IOP (mmHg)	13.8 (3.6)	13.2 (2.6)	14.3 (4.2)	0.070*
CMT	385 (51)	384 (56)	386 (46)	0.819*
* Welch two-sample t-test

BCDVA, best-corrected distance visual acuity; CMT, central macular thickness; Cylinder, cylindrical error; D, diopter; DCIVA, distance-corrected intermediate visual acuity; IOP, intraocular pressure; logMAR, logarithmic minimum angle of resolution; SD, standard deviation; Sphere, spherical error; UCDVA, uncorrected distance visual acuity; UCIVA, uncorrected intermediate visual acuity

Table 3

Summary of total operative time and macular manipulation time overall and in the two intraocular lens (IOL) groups. The corresponding p-values for the comparison between the two IOL groups are shown for each parameter evaluated.
Mean (SD)	Overall, n = 141	Tecnis-1, n = 62	Eyhance, n = 79	P-value
Total operative time (min)	25 (6)	26 (6)	25 (6)	0.893
Macular manipulation time (min)	6.26 (3.00)	6.38 (3.24)	6.16 (2.81)	0.680
* Welch two-sample t-test
SD, standard deviation

Subgroup analysis

A subgroup analysis was conducted by dividing the participants into two groups based on the preoperative spherical error: one subgroup with preoperative myopia stronger than − 1.5 Diopter (D) (Sphere < − 1.5 D) and the other subgroup with preoperative myopia weaker than − 1.5 D or with emmetropia or hyperopia (Sphere ≥ − 1.5 D). Since this study used 70 cm of intermediate visual acuity as the endpoint, we set − 1.5 D with a focal length of about 70 cm as the cutoff for the two subgroups. The comparison of visual acuity between the two IOL groups in each subgroup is presented in Tables 4 and 5. UCDVA, UCIVA, and DCIVA tended to be better in the Eyhance group in the subgroup with preoperative spherical error less than − 1.5 D.

Table 4

Subgroup analysis of visual acuity by intraocular lens (IOL) type within subgroups with preoperative spherical refraction less than − 1.5 D. The corresponding p-values for the comparison between the two IOL groups are shown for each parameter evaluated.
Mean (SD)	Tecnis-1, n = 27	Eyhance, n = 17	P-value
UCDVA	0.75 (0.32)	0.50 (0.35)	0.023
UCIVA	0.38 (0.25)	0.24 (0.17)	0.041
BCDVA	0.05 (0.09)	0.03 (0.10)	0.501
DCIVA	0.39 (0.14)	0.28 (0.18)	0.045
Welch two-sample t-test

BCDVA, best-corrected distant visual acuity; DCIVA, distance-corrected intermediate visual acuity; SD, standard deviation; UCDVA, uncorrected distant visual acuity; UCIVA, uncorrected intermediate visual acuity

Table 5

Subgroup analysis of visual acuity by intraocular lens (IOL) type within subgroups with preoperative spherical refraction with − 1.5 D or more. The corresponding p-values for the comparison between the two IOL groups are shown for each parameter evaluated.
Mean (SD)	Tecnis-1, n = 32	Eyhance, n = 55	P-value
UCDVA	0.27 (0.28)	0.35 (0.30)	0.271
UCIVA	0.39 (0.19)	0.32 (0.27)	0.135
BCDVA	0.06 (0.13)	0.12 (0.25)	0.131
DCIVA	0.42 (0.15)	0.38 (0.25)	0.355
Welch two-sample t-test

Rasch analysis of Japanese Modified Catquest-9SF results

Postoperative patient self-reported outcomes were assessed using the Japanese modified Catquest-9SF Questionnaire²². The original English version of the Catquest-9SF Questionnaire is provided in Table 6. The exact text of the Japanese modified Catquest-9SF can be found in Supplementary Table 2. A Rasch analysis was conducted on the questionnaire responses. A person-item map illustrating the distribution of patient abilities and the difficulty levels of questionnaire items is presented in the Supplementary Figure. The fit of the Rasch model was assessed using statistics known as information-weighted mean square fit statistics (Infit MNSQ) and outlier-sensitive weighted mean square fit statistics (Outfit MNSQ), which evaluate the unidimensionality of the Rasch model. Detailed statistics, along with item difficulty levels, are detailed in Table 6. Infit MNSQ and Outfit MNSQ are considered to fit within 0.5 to 1.5 logits, with values below 0.5 logits indicating overfit and values above 1.5 logits indicating underfit^23,24. In a previous study on cataract surgery patients validating the Japanese modified Catquest-9SF Questionnaire, item Q3-4, "Seeing to walk on uneven surfaces, e.g., cobblestone," did not meet the unidimensionality assumption²². In the current analysis, item Q3-2, "Recognizing the faces of people you met," showed an underfit Infit value of 1.65, indicating a deviation from the unidimensionality assumption, while the other items fell within the acceptable range of 0.5–1.5.

Table 6

Item Difficulty and Infit and Outfit MNSQ for each item of the questionnaire.
Item (Original sentence of the Catquest-9SF Questionnaire)	Item difficulty (logit)	Infit MNSQ (logit)	Outfit MNSQ (logit)
Q1. Do you find that your sight at present in some way causes you difficulty in your everyday life?	0.25	0.95	0.83
Q2. Are you satisfied or dissatisfied with your sight at present?	−2.28	0.85	0.85
Q3-1. Reading text in newspapers	−1.09	1.16	1.05
Q3-2. Recognizing the faces of people you meet	2.53	1.65	0.67
Q3-3. Seeing the prices of goods when shopping	−0.82	0.87	0.84
Q3-4. Seeing to walk on uneven surfaces, e.g., cobblestones	2.53	1.43	1.44
Q3-5. Seeing to do handicrafts, woodwork etc.	−1.67	0.94	0.91
Q3_6. Reading subtitles on TV.	0.64	1.38	1.18
Q3-7. Seeing to engage in an activity/hobby that you are interested in	−0.1	0.65	0.54

Infit MNSQ, information-weighted mean square fit statistics; Outfit MNSQ, outlier-sensitive weighted mean square fit statistics

Infit MNSQ of 0.5–1.5 is fit. <0.5 is overfit, > 1.5 is underfit

Patients’ abilities were compared based on the mean of Rasch-converted scores (using logit as the unit), and the results are summarized in Table 7. There was no significant difference in overall patients' ability between the Tecnis-1 and Eyhance groups (p = 0.231). Figure 1 illustrates the results of differential item functioning (DIF), showing differences in item difficulties, referred to as DIF contrast, between the IOL groups. In this analysis, a positive DIF contrast indicates favorability in the Eyhance group. The DIF contrast was significantly positive for Q2, "Are you satisfied or dissatisfied with your sight at present?" The DIF contrast was also significantly positive for Q3-4, "seeing to walk on uneven surfaces, e.g., cobblestones," although Q3-4 did not meet the unidimensionality assumption in the previous study validating the Japanese modified Catquest-9SF Questionnaire for patients after cataract surgery²². DIF contrast for Q3-1, "Reading text in newspapers," was significantly negative. Additionally, Q3-2 showed negative DIF contrast, but the Infit MNSQ for Q3-2 did not meet the unidimensionality assumption. To investigate factors associated with the participants achieving better scores in the Eyhance group, preoperative background characteristics were compared by dividing patients into higher and lower ability groups at a specific cutoff value of patient ability, but no clear trend was observed (Supplementary Table 3).

Table 7

Comparison of patient abilities by intraocular lens (IOL) group.
Mean (standard deviation)	Overall, n = 132	Tecnis-1, n = 60	Eyhance, n = 72	P-value
Person ability (logit)	−3.03 (1.97)	−3.26 (1.87)	−2.85 (2.03)	0.231
Welch’s two-sample t-test

This study prospectively compared the outcomes of Tecnis-1 and Eyhance in phaco-vitrectomy for ERM and cataracts from both a clinical and patient-reported perspective. Overall, there were no significant differences in postoperative BCDVA, DCIVA, UCDVA, or UCIVA between the Tecnis-1 and Eyhance groups. However, in a subgroup analysis of patients with some degree of myopia, DCIVA was significantly better in the Eyhance group, while BCDVA remained consistent. In addition, Rasch analysis of the Japanese modified Catquest-9SF Questionnaire revealed that an item related to general patient satisfaction was significantly better in the Eyhance group than in the Tecnis-1 group.

Several studies, including randomized controlled trials (RCTs), have demonstrated that the use of Eyhance in cataract surgery significantly improved intermediate visual acuity compared to Tecnis-1 while maintaining distance visual acuity^6–12,14. However, some other RCTs^16,17 and a prospective study comparing Tecnis-1 inserted in the dominant eye and Eyhance inserted in the non-dominant eye for the same patients did not show a difference in intermediate visual acuity of more than 1 line¹⁸. Also, a study in Japan comparing functional visual acuity, which reflects changes in visual function in various conditions, found no significant differences at intermediate distances¹⁹. Despite being classified as a monofocal IOL, Eyhance is expected to improve intermediate vision due to its aspheric curve with continuous refractive power change in the center of the optical part⁵. Although multifocal IOLs are considered inappropriate for patients with macular diseases such as ERM due to reduced contrast sensitivity, a study of this specific monofocal IOL inserted in patients with ERM reported a defocus curve comparable to that of control patients without ERM.²¹ Some previous studies have shown a significant improvement in intermediate visual acuity with Eyhance compared to Tecnis-1 even after phaco-vitrectomy for ERM^25,26. However, there was no significant improvement in DCIVA in the Eyhance group in the current study, possibly due to the lack of strict case-control matching between the two IOL groups. Postoperative CMT improved significantly in the Tecnis-1 group but not in the Eyhance group, with no significant differences in preoperative or postoperative CMT between the two groups. Since there were no significant differences in postoperative CMT, BCDVA, or operative time, we do not believe that Eyhance negatively influenced the surgical technique for removing ERM/ILM that can affect macular function after the surgeries. While multifocal IOLs have been reported to reduce visibility during ERM surgery, affecting macular manipulation²⁷, we did not observe a prolongation of total operative time or macular operative time in the Eyhance group in our study.

In terms of the trend of improved UCIVA, the mean postoperative spherical error was slightly higher in the Eyhance group (− 1.1 D) than in the Tecnis-1 group (− 1.8 D) in the current sample, although this difference was not statistically significant. This discrepancy may be attributed to the higher prevalence of myopia in East Asia²⁸, leading to a tendency to target myopia rather than emmetropia in postoperative IOL power selection²⁹. The use of Eyhance may have resulted in worse postoperative UCIVA due to a more emmetropic IOL power selection by operators and patients, considering the greater depth of focus. When comparing postoperative visual acuity among different IOLs within subgroups based on preoperative spherical error of − 1.5 D, both UCIVA and DCIVA tended to be better in the more myopic subgroup. This suggests that the degree of preoperative refraction may influence intermediate visual acuity. While central neurological and optical factors could contribute to these differences, further investigations are needed to validate these findings.

The overall score of the Japanese modified Catquest-9SF Questionnaire did not differ significantly between the Eyhance and Tecnis-1 groups. In this study, the results of the Japanese modified Catquest-9SF Questionnaire were analyzed using Rasch analysis, which allows for the quantification of the difficulty of questionnaire items and the ability of each patient in the same unit, as continuous variables³⁰. In addition to the previously established validity of the Rasch analysis of the Japanese modified Catquest-9SF in cataract surgery²², the current analysis mostly adhered to the assumptions of the Rasch analysis in terms of the Infit MNSQ and Outfit MNSQ, except for one question item (Q3-2). Although no significant differences were observed between the two IOL groups in terms of total patient ability scores, comparisons using DIF analysis revealed significant differences in several items. Surprisingly, despite the expected extended depth of focus with Eyhance, two items that were believed to assess near (Q3-1) or intermediate (Q3-2) distance vision were more challenging (higher logit of items) in the Eyhance group than in the Tecnis-1 group. Some previous studies comparing the results of the Catquest-9SF Questionnaire between Tecnis-1 and Eyhance in cataract surgery have reported better outcomes in the Eyhance group^8,9. However, our present results showed an opposite trend. This may be attributed to the lack of consideration of the questionnaire for eyeglass use and the more myopic postoperative spherical power in the Tecnis-1 group compared to the Eyhance group. Although the item Q3-4 "Seeing to walk on uneven surfaces, e.g., cobblestones" was significantly less challenging in the Eyhance group, it may not accurately reflect overall visual function. Previous studies of the Japanese modified Catquest-9SF Questionnaire²² and the Catquest-9SF in other countries^31,32 have shown a poor fit to the Rasch model. Regarding Q2, which asks about general patient satisfaction, previous studies comparing Eyhance and Tecnis-1 for cataract surgery have shown no significant difference. However, our analysis using the Rasch model indicates an advantage for the Eyhance group. This difference may be attributed to variations in patient populations and languages, as well as differences in the analysis method, specifically the use of the Rasch model. In the person-item map of the Eyhance group (see Supplementary Figure), we observed two peaks around − 3 and − 5 logits in the distribution of patients’ abilities. Therefore, we divided the participants at the third quartile (− 4.730 logits) to investigate the characteristics within this distribution, but no differential trend was identified. Although it remains uncertain whether such a distribution is limited to participants in this study, patients with ERM characteristics suitable for Eyhance are expected to be elucidated.

This study has several limitations. It is a prospective observational study, and studies with a higher level of evidence, such as RCTs, are required. Although there were no significant differences in the patients’ preoperative backgrounds, some unexamined factors may be involved. Another limitation is the lack of preoperative data in the questionnaire, which prevents pre- and postoperative comparisons. There were multiple surgeons, and the detailed procedures were not standardized. CMT was measured by different devices at each institution. The Japanese modified Catquest-9SF Questionnaire is a questionnaire translated by Japanese ophthalmologists and has not undergone a back-translation process. Thus, its cannot be directly compared with other language versions. In addition, the Catquest-9SF Questionnaire is designed for cataract surgery, and further examination is needed to determine if it can be appropriately used for ERM.

In summary, we found no significant difference in postoperative intermediate vision between the Eyhance and Tecnis-1 groups in postoperative patients with ERM and cataract. However, we confirmed a significant advantage in general satisfaction for the Eyhance group. Although there may be some inconvenience when viewing objects at certain distances in daily life, the monofocal IOL with enhanced intermediate function provides overall better satisfaction than conventional monofocal IOL without surgical disadvantages.

Patients

This was a multicenter prospective, nonrandomized, comparative study. The procedures used in this study adhered to the tenets of the Declaration of Helsinki. The protocol was registered in the UMIN Clinical Trial Registry (registration number UMIN000047202) and approved by the Institutional Review Board/Ethics Committee of Nagoya University Graduate School of Medicine, Nagoya, Japan (approval number 2022-0092), Fujita Health University School of Medicine, Toyoake, Japan (approval number HM22-405), the Miyake Eye Clinic, Nagoya, Japan (approval number 2022-003), Kariya Toyota General Hospital (approval number 790), Nishio Municipal Hospital (approval number 102), and Ichinomiya Municipal Hospital (approval number 1329). All participants provided informed consent. Patients scheduled for combined cataract and pars plana vitrectomy (PPV) surgery for cataract and ERM were recruited from Nagoya University Hospital, Miyake Eye Hospital, Ichinomiya Municipal Hospital, Kariya Toyota General Hospital, and Nishio Municipal Hospital between July 2022 and November 2023. The inclusion criteria were patients aged 20 or older with visual impairment due to cataracts and ERMs. The exclusion criteria comprised corneal disorders affecting visual acuity, corneal astigmatism exceeding 3.0 D, uncontrolled glaucoma, active uveitis, retinal detachment before or after surgery, sight-threatening macular disorders other than ERM (e.g., macular hole, branch retinal vein occlusion, age-related macular degeneration, central serous chorioretinopathy), proliferative diabetic retinopathy, amblyopia, congenital eye abnormalities, vitreous opacity; language barriers, and inability to complete follow-up.

Patients underwent combined surgery, and either Tecnis Optiblue (DCB00V) or Eyhance (DIB00V) IOL was implanted. The surgery was performed by K.H., H.H., S.K., or I.O. The choice of IOL was made based on the patient’s preferences after being informed about the characteristics of each IOL. The superiority of these two IOLs in combined surgery for cataracts and ERMs had not been evaluated at that time.

Preoperative evaluation

Preoperatively, all patients underwent a comprehensive ophthalmic examination, including the measurement of uncorrected and corrected visual acuity, slit-lamp biomicroscopy, non-contact tonometry, fundus examination, manifest refraction, optical biometry, corneal topography, and macular optical coherence tomography. Preoperative monocular UCDVA and BCDVA were assessed using the Snellen chart at a 5-meter distance. Intraocular pressure, spherical and cylindrical refractive errors, corneal astigmatism, pupil diameter, and CMT were recorded. The power of the IOL to be implanted was determined based on biometry data obtained from IOLMaster 500 or 700 (Carl Zeiss Meditec AG, Jena, Germany) or OA-2000 (Tomey, Nagoya, Japan). In cases where biometry data could not be obtained using these devices, contact A-scan biometry was used. IOL power was calculated according to the standard protocols of each facility.

Postoperative evaluation

The manifest refraction, BCDVA, UCDVA, UCIVA, DCIVA, intraocular pressure, and CMT were recorded during the visit 3 months after surgery. Distance visual acuity was assessed at a 5-meter distance, while intermediate visual acuity was measured at a 70 cm distance, both under photopic conditions with 100% contrast. For statistical analyses, decimal visual acuity was converted to logMAR.

Surgical procedure

A 25- or 27-gauge PPV and phacoemulsification using the Constellation System (Alcon, Inc, Geneva, Switzerland) were performed. Phacoemulsification was performed followed by IOL insertion into the capsule, then PPV and subsequent ERM/internal limiting membrane peeling were conducted. The total operative time and macular manipulation time were recorded. Postoperatively, topical antibiotics, corticosteroids, and nonsteroidal anti-inflammatory drugs were administered.

Japanese modified Catquest-9SF Questionnaire

The Japanese modified Catquest-9SF Questionnaire was used to assess the patients’ self-assessed quality of vision. Patients who underwent surgery on both eyes completed the questionnaire once, with only the first operated eye included in the questionnaire score analysis. The original Catquest-9SF Questionnaire comprises nine questions, including two global assessment items. For the item assessing general visibility difficulties (Q1), response options are: 4 = very great difficulty, 3 = great difficulty, 2 = some difficulty, and 1 = no difficulty. For the item on general satisfaction with vision (Q2), response options are: 4 = very dissatisfied, 3 = rather dissatisfied, 2 = fairly satisfied, and 1 = very satisfied. The remaining seven questions focus on vision for specific daily life activities (Q3-1 to Q3-7), and response options are: 4 = very great difficulty, 3 = great difficulty, 2 = some difficulty, and 1 = no difficulty. Responses indicating “5 = cannot decide” and the dataset with this response were excluded from the analysis. The questionnaire was machine-translated into Japanese using DeepL translation (https://www.deepl.com/ja/translator) and subsequently modified by ophthalmologists to enhance comprehension for Japanese speakers. The Japanese modified Catquest-9SF Questionnaire was previously validated through Rasch analysis elsewhere²². The sample size was determined based on a comparative study of intermediate visual acuity between Eyhance and Tecnis-1 in cataract surgery.⁹ In a previous study, it was estimated that 70 patients per group would provide over 98% power to detect a 1-line or greater difference assuming one-sided testing, an alpha of 0.05, and a standard deviation of 1.5 lines for intermediate visual acuity. For distance visual acuity, a sample size of 70 patients per group would provide over 99% power to detect a 1-line noninferiority margin, assuming a standard deviation of 1.2 lines. Regarding the Rasch analysis of the questionnaire, a sample size of 90 was considered sufficient, as the minimum sample size is typically 10 per questionnaire item³⁰.

Statistics and Rasch analysis

Statistical analyses were conducted using R version 4.3.1. Preoperative and postoperative quantitative data were compared using the Welch two-sample t-test. Fisher’s exact test was used to compare categorical data between the IOL groups. Preoperative and postoperative CMT were compared using the paired t-test with an alpha error set at 0.05. Rasch analysis for the Japanese modified Catquest-9SF Questionnaire was performed using WINSTEPS Ver.5.6.0.0. Rasch calibrated scores were treated as parametric statistics²⁰. The patient’s ability and item difficulty were converted into scores with the same “logit” scale. In this study, higher scores for a person’s ability indicated lower visual ability (stronger visual dysfunction) and higher scores for questionnaire items indicated lower difficulty (easier completion or greater satisfaction). The fit of the Rasch model was evaluated using Infit MNSQ and Outfit MNSQ. These statistics are used to assess whether the items in the questionnaire measure a single underlying construct, known as unidimensionality. Both statistics are expected to have a value of 1, with an acceptable fit criterion of 0.5 to 1.5^23,24. If the Infit MNSQ or Outfit MNSQ falls outside this range, the item is considered not to fit with the Rasch model, indicating it does not meet the model’s unidimensionality assumption. Rasch calibrated scores of patients’ ability were compared between IOL groups using Welch’s two-sample t-test. The differences in item difficulties between the Tecnis-1 and Eyhance groups were conducted using DIF analysis. DIF analysis was calculated using the DIF contrast, defined as the difference in item difficulty scores between the two groups. The significance of the DIF contrast was determined using Welch two-sample t-test. In this analysis, a larger item difficulty score in logit units indicates that the item is easier to perform and easier for the patient. Therefore, a larger DIF contrast of the Eyhance group minus the Tecnis-1 group suggests better performance of the Eyhance group on the item.

Subgroup analysis

In previous research evaluating postoperative intermediate visual acuity with Eyhance, the IOL power was typically calculated to target emmetropia^6,8–12,16. However, Japanese ophthalmologists often set IOL power to match the patients’ original refractive error, with patients who had preoperative myopia tending to target myopia rather than emmetropia²⁹. To facilitate comparison with previous studies focusing on emmetropia, a subgroup analysis was conducted dividing participants into two groups based on the preoperative spherical error: one subgroup with preoperative myopia stronger than − 1.5 D (Sphere < − 1.5 D) and another subgroup with preoperative myopia weaker than − 1.5 D or with emmetropia or hyperopia (Sphere ≥ − 1.5 D). To investigate preoperative patient characteristics associated with a favorable Rasch calibrated patient ability score on the Japanese modified Catquest-9SF Questionnaire in the Eyhance group, the Eyhance group was divided into two groups using a cutoff, and their preoperative characteristics were compared using the Welch t-test. In the subgroup analysis comparing patients with high and low patient ability scores in the Eyhance group, the cutoff for the Rasch calibrated patient ability score was set at the third quartile, − 4.37 logit, which separated the two peaks of its distribution. These subgroup analyses were exploratory and were not adjusted for multiple comparisons.

Competing Interests
The corresponding author has received research funding from Johnson & Johnson Vision, which may constitute a potential conflict of interestKMN received research grants unrelated to this work from AMO Japan Co. Ltd. and Alcon Japan Co. LtdThe other authors declare no competing interests.

Author Contribution

Conceptualization, H.K., F.H, S.K, I.O., G.M., K.M.N.; Data curation F.H., S.K., I.O., G.M., K.M., D.I., E.I., T.A.; Formal analysis, M.M.; Funding acquisition, K.H.; Investigation, J.O., A.S., K.Y., H.S.; Supervision, K.H.; Writing—J.O.; Writing—review & editing, K.H., M.M.

Acknowledgement

We would like to express our gratitude for the data integration to Seina Ito, Nagoya University.

Data Availability

The datasets generated during the current study are available from the corresponding author on reasonable request.

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Competing interest reported. The corresponding author has received research funding from Johnson & Johnson Vision, which may constitute a potential conflict of interest KMN received research grants unrelated to this work from AMO Japan Co. Ltd. and Alcon Japan Co. Ltd The other authors declare no competing interests.

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Monofocal intraocular lenses with enhanced intermediate function provide more satisfaction in phaco-vitrectomy for the epiretinal membrane and cataracts

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Abstract

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Introduction

Results

Patient background

Outcomes at 3-month visits

Subgroup analysis

Rasch analysis of Japanese Modified Catquest-9SF results

Discussion

Methods

Patients

Preoperative evaluation

Postoperative evaluation

Surgical procedure

Japanese modified Catquest-9SF Questionnaire

Statistics and Rasch analysis

Subgroup analysis

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Author Contribution

Acknowledgement

Data Availability

References

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