Comparison of long-term outcomes between implantable collamer lens V4c and FS-LASIK for myopia correction with presbyopia

doi:10.21203/rs.3.rs-3347516/v1

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Comparison of long-term outcomes between implantable collamer lens V4c and FS-LASIK for myopia correction with presbyopia

https://doi.org/10.21203/rs.3.rs-3347516/v1

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Purpose: To compare the long-term safety and efficacy of monovision surgery using implantable collamer lens (ICL) V4c and femtosecond laser-assisted in situ keratomileusis (FS-LASIK) in myopic patients with early presbyopia.

Setting: Eye and ENT Hospital of Fudan University,shanghai, China.

Design: Case series study.

Methods: 48 eyes of 24 patients were included (male/female: 10/14, mean age 45.50±3.82 years). We recorded parameters including mean spherical equivalent, uncorrected distance visual acuity, corrected distance visual acuity, intraocular pressure, presbyopic add power, visual acuity (VA) (logMAR) of dominant eyes (D-eye), non-dominant (nD-eye) eyes, and both eyes (Bi) at 0.4 m, 0.8 m, and 5 m, corneal wavefront aberration, and contrast sensitivity (CS) at the last follow-up (4.5 years, 54.00±9.77 months). Statistical significance was set at p<0.05.

Results: All surgeries were uneventful. The safety indices of ICL V4c group and FS-LASIK group were 1.17±0.30 and 0.98±0.20 (p<0.05), and the efficacy indices were 0.79±0.07 and 0.52±0.07 (p<0.05) respectively. The binocular VA (logMAR) of ICL V4c group and FS-LASIK group at 5.0 m were: 0.02±0.11, 0.18±0.30; 0.8 m: 0.09±0.12, -0.01±0.11; 0.4 m: -0.02±0.06, -0.03±0.08, (p>0.05 at three distances). Compared with ICL V4c group, lower CS was observed at 1.0 cpd in the FS-LASIK group (1.07±0.31 vs. 0.80±0.51, p=0.043).

Conclusions: Implantable collamer lens V4c and FS-LASIK are safe and practicable for correction of myopes with presbyopia. Compared with the FS-LASIK group, the ICL V4c group showed superior CS in nD-eyes in low spatial frequency.

myopia

presbyopia

monovision

FS-LASIK

ICL V4c

wavefront aberration

contrast sensitivity

safety

efficacy.

What Was Known

Myopic presbyopes may be managed with monovision using excimer laser or SMILE, glasses, contact lenses, corneal inlays, LASIK, ICL implantation and lens replacement.
Long-term safety and efficacy of refraction surgery using ICL V4c and FS-LASIK.

What This Paper Adds

Implantable collamer lens V4c and FS-LASIK are safe for correction of myopes with presbyopia.
Monovision surgery using ICL V4c or FS-LASIK provides long-term good binocular vision in myopic presbyopes.
Compared with the FS-LASIK group, the ICL V4c group shows superiority of CS in nD-eyes in low spatial frequency.

How this study might affect research, practice or policy

Implantable collamer lens V4c and FS-LASIK are practicable for correction of myopia in patients over 40 years old.

In 2015, 1.8 billion people had presbyopia worldwide¹ and the number increased to 2.1 billion in 2020.² By 2050, the population of individuals with myopia is estimated to reach 4.758 billion, 938 million of whom are expected to have high myopia.³ As the population ages, the number of people with myopia and presbyopia over the age of 40 will greatly increase. Monovision is a commonly used clinical method for the treatment of myopia with presbyopia,⁴ by correcting the distant vision of the dominant eye (D-eye) and the near vision of the non-dominant eye (nD-eye). Monovision can be carried out using frame spectacles, contact lenses, corneal inlays, Implantable Collamer Lens (ICL) implantation, and lens replacement.^{2, 5}

Currently, mainstream refractive surgery such as corneal refractive surgery and ICL implantation has great potential for the correction of myopia with presbyopia. The safety and efficacy indices were significantly lower in patients > 40 years old 6 months after femtosecond laser small incision lenticule extraction (SMILE), with astigmatism residue and a tendency of undercorrection.⁶ Femtosecond laser fabrication of corneal flaps helps to improve the predictability, accuracy, and stability, and makes laser-assisted in situ keratomileusis (LASIK) surgery safer and more accurate. Femtosecond laser-assisted in situ keratomileusis (FS-LAISK) is potentially used to correct high myopia with presbyopia.^{7, 8} With the development and clinical application of ICL V4c, the misgivings regarding ICL implantation-related acceleration of cataract formation have been further reduced or even eliminated.^{9, 10} A previous study showed that it is safe and effective to correct ametropia in myopic patients aged 40 and above.¹¹

However, few studies have focused on the long-term application of ICL V4c and FS-LASIK in monovision surgery. The long-term effect and detailed comparison of the two surgeries in patients with myopia and presbyopia remain unclear, especially in visual quality and contrast sensitivity. Therefore, this study aimed to investigate and compare the long-term safety, efficacy, and characteristics of visual quality and contrast sensitivity in these patients, thus providing the basis for their clinical application.

Subjects

This observational consecutive case series study was conducted at the Eye and ENT Hospital of Fudan University, Shanghai, China, between June 2015 and December 2021. 48 eyes of 24 patients with early presbyopia (male/femalemen/women: 10/14, average age: 45.50 ± 3.82 years, Table 1) were enrolled and recieved binocular FS-LASIK (24 eyes of 12 patients) or ICL V4c implantation (24 eyes of 12 patients) for myopia correction with presbyopia. This study was approved by the Ethics Committee of the Eye and ENT Hospital of Fudan University (2013015) and conducted in accordance with the Declaration of Helsinki. We obtained written informed consent from all patients before performing all procedures.

Table 1

Preoperative patient demographics
Characteristic	Mean ± SD	Range	ICL V4c Group	FS-LASIK Group	P
Age(years)	45.50 ± 3.82	(40,54)	43.75 ± 2.31	47.25 ± 4.21	0.033
Gender(male/female)	10/14		5/7	5/7	1.000
Axial length(mm)	27.13 ± 2.12	(23.98, 32.11)	28.47 ± 2.10	26.45 ± 1.63	0.001
Refraction sphere(D)	-9.40 ± 3.90	(-19.00, -2.25)	-11.05 ± 3.42	-7.74 ± 3.69	0.002
Refraction cylinder (D)	-1.13 ± 0.93	(-3.25, 0)	-1.49 ± 1.07	-0.77 ± 0.58	0.006
SE (D)	-9.96 ± 4.00	(-19.00, -2.25)	-11.80 ± 3.36	-8.13 ± 3.78	0.001
CDVA (LogMAR)	-0.03 ± 0.07	(-0.18, 0.22)	0.05 ± 0.08	-0.01 ± 0.08	0.010
Dominant eye (OD/OS)	14/10	NA	6/6	8/4	NA
ADD (D)	1.02 ± 0.66	(0.50, 2.50)	0.71 ± 0.33	1.33 ± 0.77	0.017
K-flat(D)	43.57 ± 1.37	(40.80, 46.60)	43.34 ± 1.54	43.80 ± 1.15	0.254
K-steep(D)	44.68 ± 1.42	(42.30, 47.20)	44.96 ± 1.64	44.40 ± 1.14	0.174
WTW (mm)	11.86 ± 0.33	(11.00, 12.40)	11.79 ± 0.35	11.94 ± 0.28	0.134

The inclusion criteria were age ≥ 40 years with transparent lens, the progress of myopia < 0.5D/y within 2 years, no use of soft contact lens for ≥ 2 weeks, or rigid gas permeable contact lens for ≥ 4 weeks, and presbyopic add power ≥ + 0.50 D. The exclusion criteria were diagnosis or suspected diagnosis of keratoconus, history of ocular inflammation or trauma, lens opacity, glaucoma, previous eye surgery, other diseases of the eye or systemic diseases, and corneal endothelial cell density (ECD) < 2000 cell/mm² or anterior chamber depth (ACD) < 2.8 mm in ICL V4c group.

Equipment and measured parameters were 1. Phoropter (RT-5100, Nidek Technologies, Japan): Spherical equivalent (SE), corrected-distance VA (CDVA), uncorrected-distance VA (UDVA), and prebyopic add power (ADD). Definitions: safety index (SI) = postoperative CDVA / preoperative CDVA, efficacy index (EI) = the postoperative UDVA / preoperative CDVA. Card-hole method was used to determined the D-eyes and nD-eyes and Fusion Cross-Cylinder (FCC) method was used to measure ADD at a 33cm distance with optimal distance visual acuity correction. 2. Canon Full Auto Tonometer TX-F (Canon, Inc., Tokyo, Japan): Intraocular pressure (IOP). 3. Pentacam HR (Oculus Optikgerate Wetzlar, Wetzlar, Germany): Corneal thickness (CT), anterior chamber volume (ACV), ACD, anterior chamber angle (ACA), and white-to-white (WTW). 4. SP-2000P (Topcon Corporation, Kyoto, Japan): ECD. 5. IOL Master 700 (Carl Zeiss AG, Germany): WTW. 6. IOL Master 500 (Carl Zeiss AG, Germany): axial length (AL). 7. I.Profiler (Zeiss AG, Germany) was used to measure corneal aberrations within the 5.00-mm radius of the pupil centre. 8. qCSF tests were carried out using Adaptive Sensory Technology (AST, American). The Area Under Line of Contrast Sensitivity Function (AULCSF), CSF Acuity, and contrast sensitivity (CS) under 1.0,1.5,3.0,6.0,12.0 and 18.0cpd were measured. The detailed principle and method have been reported previousy.^{12, 13}

Slit lamp examination and fundus examination were completed after pupillary dilation to check the lens transparency and exclude fundus lesions.

Monovision

The ICL size was calculated according to white-to-white distance, anterior chamber depth, and angle to angle distances. (STAAR Surgical, http://en.informer.com/icl-power-calculation-software/, Version 3.0). The size was adjusted based on the WTW value from Pentacam and referred value from the IOL master.. targeted SE: -0.50 to 0.25 D for D-eyes in the ICL V4c and FS-LASIK groups,and − 1.75 to -0.50 D and − 2.25 to -0.50D for nD-eyes in the two groups respectively.the target value were determined according to the presbyopic add power of each patient.Residual myopic diopters was on trial in frame glasses preoperatively and accepted by the involved patients.

Surgeries

The surgeon (XZ) performed all surgeries. Antibiotic eye drops were administered 4 times a day for 3 days before surgery. In FS-LASIK surgery, a 500 kHz VisuMax femtosecond laser system (Carl Zeiss Meditec, Jena, Germany) with a pulse energy of 130 nJ was used for flap creation, and a MEL 90 excimer laser (Carl Zeiss Meditec) with a pulse energy of 185 nJ for stromal ablation. Flap diameter and thickness were 7.5 mm and 100 µm respectively, with standard 90° hinges and 90° side cut angles. The planned optic zone of 6.35 ± 0.25 mm (range 6.10 to 6.70). After FS-LASIK, a soft contact lens was worn and removed at 1 day postoperatively. Topical levofloxacin, 0.1% fluorometholone solution and non-preserved artificial tears were used after FS-LASIK. The detailed steps are described in a previous study.¹⁴

In ICL V4c implantation surgeries, after topical anaesthesia, a viscoelastic agent was injected in the anteriror chamber followed with implantation of ICL V4c through the lateral corneal incision. Thereafter, the the manipulator was used for ICL adjustment, and a balanced salt solution was used to replace the viscoelastic agent. Postoperatively, antibiotic and steroid eye drops were administered. The detailed steps are described in a previous study.¹⁵

Follow-up

We followed up the patients for 4.5 years, with a follow-up period of 45 to 75 months, and an average of 54.00 ± 6.77 months. The relevant parameters were measured at 1 month postoperatively (ECD at 3 months postoperatively) and the last follow-up.

At the last follow-up, we recorded CDVA and UDVA (logMAR) of D-eyes, nD-eyes, and both eyes at 0.4 m, 0.8 m, and 5 m. Measurements were performed using two trial frames and two tumbling E charts (VSK-VC-J 0.4m/0.8m, Wehen Vision, China) for the monocular and binocular VA at the distance of 0.4 m and 0.8 m, respectively, and phoropter was used for monocular and binocular distant VA at 5 m. The subjective satisfaction of VA at near and far distances was recorded preoperatively, 3 months postoperatively, and at the last follow-up (scores 1–5: 1, very dissatisfied; 2, dissatisfied; 3, satisfactory; 4, highly satisfactory; and 5, excellent).

Statistical analysis

The results are expressed as mean ± standard deviation. All statistical analyses were performed using the Statistical Package for the Social Sciences software version 25.0. (SPSS, Inc., Chicago, IL, USA). Kolmogorov–Smirnov test was used for Normality check. We used repeated ANOVA to compare the pre- and post-treatment normally distributed data between D- and nD-eyes. One-way ANOVA was used to compare normally distributed data measured only at the last follow-up between the D- and nD-eyes, such as aberration and qCSF test results. Wilcoxon signed-rank test was used for non-normally distributed data. Statistical significance was set at p < 0.05.

Safety

All surgeries were uneventful. The safety indices of the ICL V4c group at 1 month and 54 months postoperatively were 1.27 ±0.22 and 1.17 ±0.30 (p >0.05), respectively. The corresponding values of the FS-LASIK group were 1.01 ±0.07 and 0.98 ±0.20 (p >0.05), respectively. (p<0.001 between groups at all time points) Supplementary Table 1 and Supplementary Table 2 provide the visual and biometric parameters of the D-eyes or nD-eyes between two groups, respectively. Figure 1 and Figure 2 show the CDVA and UDVA (Figure 1 [A][B][C], Figure 2 [A] [B][C])outcomes of the two groups respectively.

In the ICL V4c group, the preoperative, 3-months, and 54-months postoperative ECD were 3109.41±126.92 cell/mm², 2767.77 ±61.1 cell/mm²(vs. preoperative, p=0.067),and 2571.36 ±62.02 cell/mm² (vs. preoperative, p =0.016 and vs. 3-mon postoperative, p =0.026), respectively.

Efficacy

The efficacy indices of the ICL V4c group at 1 month and 54 months postoperatively were 1.12 ±0.25 and 0.79 ±0. 07 (p >0.05), respectively. The corresponding figures for the FS-LASIK group were 0.79 ±0.06 and 0.52 ±0.07 (p >0.05), respectively. (p <0.01 between groups at all time points)

Predictability

There was a significant linear correlation in the two groups between the achieved SE and the attempted value (p < 0.001). (Figure 1 [D], Figure 2 [D])At the last follow-up, the SE in 66.67% and 58.33% of the eyes was within ±0.50 D of the attempted value and that in 95.83% and 83.33% of the eyes was within ±1.00D of the target value in ICL V4c group (Figure 1 [E]) and FS-LASIK group (Figure 2 [E]), respectively.

Stability

Spherical equivalent in the ICL V4c group were -11.80 ±3.36 D, -0.28 ±0.69 D, and -0.80 ±0.59 D preoperatively, 1 month, and 54 months postoperatively, respectively. (Figure 1 [F]) The corresponding figures for the FS-LASIK group were -8.13 ±3.78 D, -0.84 ±1.05 D, and -1.43 ±1.14 D, respectively.( Figure 2 [F]) The change of SE in two groups between two follow-up time points were -0.52 ±0.18 D and -0.59 ±0.18 D, (p =0.76) respectively.

Monovision

The preoperative and 54 months postoperative ADD values of the two groups are shown in Supplementary Table 1. The progression of presbyopia in ADD was 0.69 ±0.60 D and 0.48 ±0.41 D in the ICL V4c and FS-LASIK groups, respectively, and the values were equivalent to 0.14 ±0.13 D per year and 0.10 ±0.09 D per year (p=0.248), respectively. Figure 3 and Figure 4 present the uncorrected visual acuity at near to far distances (Figure 3 [A], Figure 4 [A]) and its distribution in D-eyes (Figure 3 [B], Figure 4 [B]), nD-eyes (Figure 3 [C], Figure 4 [C]) and binocular (Figure 3 [D], Figure 4 [D]) of two groups at 54 months after ICL V4c implantation, respectively.

Subjective satisfaction

Supplementary Figure 1 describes the subjective satisfaction with distance and near VA preoperatively, 3 months postoperatively, and at the last follow-up. In the ICL V4c group, the satisfaction rates (scores 4 or 5) of near VA were 33.3%, 91.67%, and 66.67% respectively, and that of distance VA at three follow-up time points were 0%, 83.33%, and 80.00%, respectively. In the FS-LASIK group, the satisfaction rates of near VA were 33.3%, 83.33%, and 66.67% respectively, and that of distance VA at three follow-up time points were 0%, 83.33%, and 50.00%, respectively.

Aberrations

There was no significant difference in wavefront aberrations between the dominant and non-dominant eyes in the two groups at the last follow-up (Supplementary Figure 2). There was no significant difference between the two groups in HOAs; however, the FS-LASIK group showed significantly higher coma and spherical aberration, and significantly lower trefoil compared with the ICL V4c group.

qCSF

Supplementary Table 3 provides the CS at different spatial frequencies at the last follow-up. There was a significant difference between the dominant and non-dominant eyes in CS at 1.0-3.0cpd AULCSF and CSF Acuity in the FS-LASIK group. (Figure 5 [A][B]). There was no significant difference between the dominant and non-dominant eyes in ICL V4c group or binocular comparison of the two groups (Figure 5 [C]).

The safety index was 1.17 and 0.98 in the ICL V4c and FS-LASIK groups, respectively, 54 months postoperatively, and this was similar to that of 1.22 in 43-months follow-up after ICL V4c implantation in patients over 40 years in a previous study.¹⁶ The ICL V4c showed better SI at the last follow-up, which was in coordination with the effect of the enlarged object image with ICL compared with LASIK.¹⁷ There was no significant difference in ECD between the preoperative and 3 months postoperative level, which decreased by 1.75% per year in the postoperative follow-up. A previous study suggested a decrease rate of 0.6% per year in healthy adults¹⁸ and 0.93%-4% per year in post-ICL-implantation long-term follow-up.¹⁹ Relatively higher ECD decrease rates might be related to older age. The ECD was > 2000 cell/mm² in all subjects at the last follow-up. This study provides further support for 4.5 years long-term safety of ICL V4c implantation and FS-LASIK in patients with myopia and presbyopia. The FS-LASIK shows its feasibility in myopes over − 11.00D where SMILE might be limited. Thus, this study chose FS-LASIK instead of SMILE as a comparison of ICL V4c implantation in anticipation of more subjects with high or ultra-high myopia in ICL V4c groups.

In predictability, SE in 95.83% and 83.33% eyes was within ± 1.00D of the target value in the two groups respectively, which was similar to a previous 43-months follow-up study of ICL V4c implantation in patients over 40 years old with 96.67% of eye within ± 1.00D of the target value. An increased myopia with − 0.52 D and − 0.59 D degree in two groups was acceptable in 54-months follow-up. Subjects were counselled about the possibility of myopia progression especially in patient over − 10.00D in this study.

The ADD progression rates were similar between ICL V4c group (0.10 D per year), FS-LASIK group (0.14 D per year), and a previous study (0.17D per year) on 43-months follow-up of ICL V4c implantation in patients with myopia and presbyopia.¹⁶ Monovision surgery using ICL V4c or FS-LASIK provides similarly good binocular VA at near-to-far distance. This also accords with our earlier observations, which showed that, at 0.4m, 0.8m, and 5.0m distance, the average binocular VA was < 0.04 Logmar and uncorrected binocular VA in 68.75% of subjects was 20/20 or better.¹⁶ The subjective satisfaction agrees with previous findings (81.25% for near VA and 87.50% for distance VA). Specifically, the subjective satisfaction rate of near VA and distance VA between two postoperative time points was separately observed to decrease significantly in the ICL V4c and FS-LASIK groups. The decrease in subjective satisfaction rate of near VA might be because of the relatively higher ADD progression in the ICL V4c group (0.69 D vs. 0.48D), whilethat of distance VA might be due to higher preoperative ADD in the FS-LASIK group (1.33 D vs. 0.71 D), as more refraction sphere was reserved in nD-eyes in this group.

The trefoil aberration was higher in ICL V4c group than FS-Lasik group. There are several possible explanations. Firstl, the centre of ICL might deviate from the visual axis;²⁰ second, it might be attributed to the corneal incision;²⁰ third, the pupil dilation under scotopic environment in aberration measurement, as the optical zone might be relatively smaller.^{21, 22} Meanwhile, FS-LASIK might introduce coma and spherical aberration due to eccentric ablation.²³

The novel qCSF test was first applied for CSF evaluation in comparison between D-eye and nD-eye, and between ICL V4c implantation and FS-LASIK. In particular, the qCSF test were carried out by not correcting the distance refraction error for more clinical practice value. A previous study reported that age instead of refraction error was significant correlated with qCSF readings.²⁴ Thus, in this study we aimed to explore the qCSF characteristics in the daily use of D-eye and nD-eye after monovision surgery. Compared with the FS-LASIK group, the ICL V4c group showed superiority of CS in nD-eyes in low spatial frequency.

This study had three limitations. First, this study was a single-centre study with relatively small subjects. Multicentre studies with larger subjects are needed to provide high-quality clinical evidence; second, the study did not include the preoperative results of aberration and qCSF test due to the upgrading of equipment. The comparison between D-eyes and the nD-eyes was done at the last follow-up; third, inadequate match limited by the differences of characteristics and indications. A better-matched pair study would provide more solid evidence.

In conclusion, ICL V4c and FS-LASIK are safe and practicable for correction of myopia with presbyopia, with long-term efficacy and good subjective satisfaction at near and far distances. Compared with FS-LASIK, ICL V4c shows superiority of CS in nD-eyes in low spatial frequency.

Acknowledgements: We would like to thank Editage (www.editage.cn) for English language editing.

Statement of Ethics: This study followed the tenets of the Declaration of Helsinki and was approved by the ethics committee of the Eye and ENT Hospital of Fudan University (2013015). Informed consent was obtained from all participants.

Consent for Publication: Written informed consent was obtained from the patients for the publication of this paper. Patient names and the eyes/facial region of study participants is not applicable.

Competing interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding:

1）National Natural Science Foundation of China (Grant No. 82371096)；

2）Project of Shanghai Science and Technology (Grant No.20410710100)

3）Project of Shanghai Xuhui District Science and Technology（XHLHGG202104）

4）Shanghai Engineering Research Center of Laser and Autostereoscopic 3D for Vision Care（20DZ2255000）

Authors' contributions: Study concept and design (YY, ZZ, JZ, XZ); data collection (YY, ZZ, FL, LN, WS, XW, JZ); data analysis and interpretation (YY, FL); drafting of the manuscript (YY, FL, JZ, XZ); critical revision of the manuscript (JZ, XZ); supervision (XZ). All authors read and approved the final manuscript.

Availability of Data and Material (ADM):

The datasets generated and/or analysed during the current study are not publicly available due funding requirement but are available from the corresponding author on reasonable request.

Synopsis/Precis

Implantable collamer lens V4c and Femtosecond laser-assisted in situ keratomileusis are practicable for correction of myopia in patients over 40 years old

Fricke TR, Tahhan N, Resnikoff S, et al. Global Prevalence of Presbyopia and Vision Impairment from Uncorrected Presbyopia. Ophthalmology. 2018;125(10):1492-1499.
Lindstrom RL, MacRae SM, Pepose JS, et al. Corneal inlays for presbyopia correction. Curr Opin Ophthalmol. 2013;24(4).
Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036-1042.
Jain S, Arora I, Azar DT. Success of monovision in presbyopes: review of the literature and potential applications to refractive surgery. Surv Ophthalmol. 1996;40(6):491-499.
Binder PS. Intracorneal Inlays for the Correction of Presbyopia. Eye & Contact Lens: Science & Clinical Practice. 2017;43(5):267-275.
Primavera L, Canto-Cerdan M, Alio JL, et al. Influence of age on small incision lenticule extraction outcomes. Brit J Ophthalmol. 2020:2020-316865.
Chen S, Feng Y, Stojanovic A, et al. IntraLase Femtosecond Laser vs Mechanical Microkeratomes in LASIK for Myopia: A Systematic Review and Meta-analysis. J Refract Surg. 2012;28(1):15-24.
Kim JY, Kim MJ, Kim T, et al. A Femtosecond Laser Creates a Stronger Flap than a Mechanical Microkeratome. Invest Ophth Vis Sci. 2006;47(2):599-604.
Shimizu K, Kamiya K, Igarashi A, et al. Early clinical outcomes of implantation of posterior chamber phakic intraocular lens with a central hole (Hole ICL) for moderate to high myopia. The British journal of ophthalmology. 2011;96:409-412.
Shimizu K, Kamiya K, Igarashi A, et al. Intraindividual comparison of visual performance after posterior chamber phakic intraocular lens with and without a central hole implantation for moderate to high myopia. Am J Ophthalmol. 2012;154(3):486-494.
Tañá-Rivero P, Pastor-Pascual F, Crespo M, et al. Posterior-Chamber Phakic Intraocular Lens Implantation in Patients over 40 Years of Age. J Ophthalmol. 2020;2020:7457902.
Vilaseca M, Peris E, Pujol J, et al. Intra- and Intersession Repeatability of a Double-Pass Instrument. Optometry Vision Sci. 2010;87(9).
Ieong A, Hau SCH, Rubin GS, et al. Quality of Life in High Myopia before and after Implantable Collamer Lens Implantation. Ophthalmology. 2010;117(12):2295-2300.
Han T, Xu Y, Han X, et al. Three-year outcomes of small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for myopia and myopic astigmatism. Brit J Ophthalmol. 2019;103(4):565-568.
Chen X, Miao H, Naidu RK, et al. Comparison of early changes in and factors affecting vault following posterior chamber phakic Implantable Collamer Lens implantation without and with a central hole (ICL V4 and ICL V4c). Bmc Ophthalmol. 2016;16(1):161.
Ye Y, Zhao J, Zhang Z, et al. Long-term follow-up for monovision surgery by Implantable Collamer Lens V4c implantation for myopia correction in early presbyopia. Graefe's Archive for Clinical and Experimental Ophthalmology. 2022.
Kamiya K, Shimizu K, Kawamorita T, et al. [Effects of myopic correction by replacement of spectacles, laser in situ keratomileusis, and phakic intraocular lens implantation on modulation transfer function and retinal magnification]. Nippon Ganka Gakkai zasshi. 2008;112:519-524.
Bourne W, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophth Vis Sci. 1997;38:779-782.
Yang W, Zhao J, Sun L, et al. Four-year observation of the changes in corneal endothelium cell density and the correlated factors after Implantable Collamer Lens V4c implantation. Br J Ophthalmol. 2020.
Wan T, Yin H, Wu Z, et al. Comparative Study of Implantable Collamer Lens Implantation in Treating Four Degrees of Myopia: Six-Month Observation of Visual Results, Higher-Order Aberrations, and Amplitude of Accommodation. Curr Eye Res. 2020;45(7):839-846.
Kamiya K, Igarashi A, Shimizu K, et al. Visual Performance After Posterior Chamber Phakic Intraocular Lens Implantation and Wavefront-Guided Laser In Situ Keratomileusis for Low to Moderate Myopia. Am J Ophthalmol. 2012;153(6):1178-1186.
Pérez-Vives C, Domínguez-Vicent A, Ferrer-Blasco T, et al. Optical quality of hyperopic and myopic phakic intraocular lenses. Indian J Ophthalmol. 2014;62(4):437-441.
Miao H, Tian M, Xu Y, et al. Visual Outcomes and Optical Quality After Femtosecond Laser Small Incision Lenticule Extraction: An 18-Month Prospective Study. Journal of refractive surgery (Thorofare, N.J. : 1995). 2015;31(11):726-731.
Li Z, Hu Y, Yu H, et al. Effect of age and refractive error on quick contrast sensitivity function in Chinese adults: a pilot study. Eye. 2021;35(3):966-972.

No competing interests reported.

SupplementaryFigure1.tif
Supplementary Figure 1.Subjective Visual Acuity Satisfaction at near and far distances in ICL V4c group [A] and FS-LASIK group [B]. *: p＜0.05 **: p＜0.01 ***: Preop vs. Postop, p＜0.001 Postop = postoperative; Preop = preoperative; mon = month(s).
SupplementaryFigure2.tif
Supplementary Figure 2.Aberration of Dominant eyes, nonDominant eyes and Binocular in ICL V4c group [A] and FS-LASIK group [B].
ICL V4c vs. FS-LASIK, p＜0.05
SupplementaryTables.docx

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Comparison of long-term outcomes between implantable collamer lens V4c and FS-LASIK for myopia correction with presbyopia

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INTRODUCTION

MATERIALS AND METHODS

Subjects

Monovision

Surgeries

Follow-up

Statistical analysis

RESULTS

DISCUSSION

Declarations

References

Additional Declarations

Supplementary Files

ICL V4c vs. FS-LASIK, p＜0.05

Status:

Version 1