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 Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 33  |  Issue : 2  |  Page : 77-85

Phakic foldable angle-supported intraocular lens versus laser in-situ keratomileusis for correction of moderate and high myopia


1 Ophthalmology Department, Faculty of Medicine, Benha University, Benha, Egypt
2 Benha Ophthalmology Hospital, Benha, Egypt

Date of Submission27-Apr-2016
Date of Acceptance05-May-2016
Date of Web Publication1-Mar-2017

Correspondence Address:
Mohamed Omar Mostafa
1 Ali Hegab St, Benha, Kalubeia Governorate
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1110-208X.201288

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  Abstract 

Objective
The objective of this study was to compare the role of phakic foldable angle-supported intraocular lens (IOL) with laser in-situ keratomileusis (LASIK) for correction of moderate and high myopia.
Patients and methods
Twenty eyes received phakic foldable angle-supported IOL, and 20 eyes received LASIK. Main outcome: slit-lamp microscopy, manifest refraction, uncorrected and best-corrected visual acuity (BCVA), pentacam, IOL calculation (for group 1) with the IOL Master, and specular microscopy were performed before surgery, and 3 and 6 months after surgery.
Results
At 6 months, the mean spherical equivalent refraction was −0.31 ± 0.44 D (ranging from 0.5 to −1.25 D) in Cachet eyes and −1.04 ± 0.94 D (ranging from 0.25 to −3.5 D) in LASIK eyes. Neither Cachet eyes nor LASIK eyes lost two or more LogMar lines of preoperative BCVA. No Cachet eyes and one LASIK eye lost one LogMar line of preoperative BCVA. The mean percentage of endothelial cell loss in the Cachet group was 8.0% at 6 months, whereas in the LASIK group it was 0.84% at 6 months.
Conclusion
In this study, Cachet lens implantation and LASIK were found to be effective for the correction of moderate and high myopia. The endothelial cell loss in Cachet eyes was high, which makes it less safe compared with LASIK.

Keywords: foldable angle-supported intraocular lens, high myopia, laser in-situ keratomileusis, moderate myopia, phakic intraocular lens


How to cite this article:
El Gazzar HA, Kamal OM, Attia TN, Mostafa MO. Phakic foldable angle-supported intraocular lens versus laser in-situ keratomileusis for correction of moderate and high myopia. Benha Med J 2016;33:77-85

How to cite this URL:
El Gazzar HA, Kamal OM, Attia TN, Mostafa MO. Phakic foldable angle-supported intraocular lens versus laser in-situ keratomileusis for correction of moderate and high myopia. Benha Med J [serial online] 2016 [cited 2021 Dec 5];33:77-85. Available from: http://www.bmfj.eg.net/text.asp?2016/33/2/77/201288


  Introduction Top


Globally, myopia is the leading cause of distance refractive error, affecting 1.45 billion or 27% of the world's population in 2010 [1]. The main objective of refractive surgery is improving the patient's quality of life by decreasing their dependence on spectacles and contact lenses [2]. Laser in-situ keratomileusis (LASIK) is now extensively recognized as a predictable and effective refractive surgical procedure for the correction of myopia and myopic astigmatism [3]. Although LASIK has been shown to be a very effective procedure for the correction of low to moderate myopia, high to extremely high myopia (>−9.00 D) still remains challenging because of many of these patients having refractive errors and corneal thickness outside the range of treatment with LASIK [4].

When keratorefractive surgery is not the appropriate approach in a determined patient, phakic intraocular lens (PIOL) or refractive lens exchange with an intraocular lens (IOL) implantation are the two other available options [5]. Clear lens extraction has some significant complications, which limits its widespread adoption, the primary concern being an increased risk of retinal detachment [6]. Refractive lens exchange causes loss of accommodation [7]. Numerous studies have shown that PIOL implantation results in favorable outcomes in high myopic patients, and it is preferred over LASIK in the recent decade [8]. The main disadvantages of the iris-fixated PIOL are the difficulty of implantation, the potential damage to the iris, the need for a large incision with the polymethyl methacylate (PMMA) lenses, and the relative proximity to the endothelium. However, posterior chamber lenses have the highest risk of inducing lenticular opacities [2].

AcrySof angle-supported phakic intraocular lens

The AcrySof angle-supported PIOL is foldable hydrophobic acrylic IOL, permitting a small corneal incision size (2.6 mm) to perform the IOL implantation. Haptics are designed to permit compression within the angle for IOL stability and without excessive force that would result in pupil ovalization or angle tissue damage. The IOL is vaulted to provide optimal central clearance between the IOL and the cornea and the natural crystalline lens. There are four model designations of IOLs with different diameters that can be chosen for varying anterior chamber dimensions [4]. They are also designed to permit the flow of aqueous through the pupil without the need of an iridectomy to bypass the pupillary block that occurred with previous anterior chamber PIOLs [9].


  Patients and methods Top


The patients were selected from the outpatient ophthalmology clinic of Benha University Hospital, and operations were performed between June 2013 and January 2015. Investigations were conducted in the eye subspecialty center (Cairo). PIOL was implanted in Dar-Elououn Eye Hospital and the Eye Subspecialty Center (Cairo), and LASIK was performed in Ebsar Eye Center (Benha). All patients had the same procedure in both eyes. This study includes two groups, and each group comprises 20 eyes:

Group 1: This group was subjected to phakic foldable angle-supported IOL with AcrySof (Cachet) phakic angle-supported IOL (Alcon Inc., Fort Worth, TX, USA).

Group 2: This group was subjected to LASIK. The Allegreto (wavelight) EX500 excimer laser (WaveLight, Erlangen, Germany) was used. All LASIK flaps had been cut using a Moria M2 (Moria, Antony, France) microkeratome with turbine motor head (Moria).

Inclusion criteria

The inclusion criteria were age between 21 and 48 years, a stable refractive error during the previous 6 months before surgery, a preoperative spectacle spherical power between −6.00 and −16.50 D, and anterior chamber depth (ACD) of 3.2 mm or more.

Exclusion criteria

Exclusion criteria were astigmatism greater than 2.00 D, previous corneal or ocular surgery, abnormal cornea such as corneal opacity, abnormal pupil or pupil greater than 7.0 mm in mesopic light conditions, any type or degree of cataract, anterior segment pathology, glaucoma or any intraocular pressure greater than 21 mmHg, posterior segment pathology, and unrealistic expectations concerning the outcome.

Emmetropia was the target refraction in all eyes. All patients signed a written informed consent before surgery. All patients received complete ophthalmological examination including refraction, uncorrected visual acuity (UCVA) using counting fingers and Snellen's visual acuity chart, and best-corrected visual acuity (BCVA) using Snellen's visual acuity chart. The results were then converted to LogMar, slit-lamp examination, intraocular pressure measurement using Goldmann's applanation tonometer, and fundus examination.

Investigations

Endothelial cell density was calculated using the specular microscope Tomey EM-3000 (Tomey Corporation, Nagoya, Japan). IOL calculation (for group 1) was performed using the IOL Master: a Zeiss IOL Master (Carl Zeiss AG, Oberkochen, Germany). Corneal topography and pachymetry were performed using the Pentacam (oculyzer; WaveLight, Erlangen, Germany).

Postoperative follow-up

Patients were examined on the first postoperative day and 1 week, 1 month, 3 months, and 6 months after surgery. During each visit, we measured refraction, UCVA, BCVA, and slit-lamp examination. Pentacam and specular microscope were used for follow-up (3 and 6 months after surgery(.

The IOL stability in the anterior chamber was assessed at each postoperative visit through slit-lamp examination, using the centerline of the IOL (a line along the optic diameter extending across both haptics). Intraocular lens position was recorded in four 15°-increment categories (1–15, 15–30, 30–45, and 45–60°).

Scheimpflug imaging: The distance between the corneal endothelium and the anterior surface of the IOL was measured to evaluate IOL position in the anterior chamber and change over time.

Methods of statistical analysis

The data were recorded on an ‘Investigation report form’. These data were tabulated, coded, and then analyzed using the computer program SPSS (Statistical Package for Social Science, South waker drive, Chicago, USA) version 16 to obtain descriptive data: descriptive statistics were calculated for the data in the form of mean ± SD, number, and percent.

Analytical statistics

In the statistical comparison between the two groups, the significance of difference was tested using one of the following tests: Student's t-test was used to compare between the mean of two groups of numerical (parametric) data. For continuous nonparametric data, Mann–Whitney U-test was used for intergroup analysis and intergroup comparison of categorical data was performed by using χ2-test (χ2-value). A P-value less than 0.05 was considered statistically significant (S), and a P-value less than 0.0001 was considered highly significant (HS) in all analyses.


  Results Top


Epidemiology

Age and sex

Group A (Cachet) included eight men (40%) and 12 women (60%), with a mean age of 27 ± 4.72 years, ranging from 22 to 37 years. Group B (LASIK) included nine men (45%) and 11 women (55%), with a mean age of 31.4 ± 8.8 years, ranging from 21 to 48 years (P = 0.562).

Visual acuity

Uncorrected visual acuity

No patient had UCVA of 1.0 LogMar (6/60) or better before surgery in both groups. In group A, the preoperative UCVA ranged from counting fingers (CF) at 50 cm to 2/60, whereas in group B it ranged from 2/60 to 5/60. The UCVA of the two groups at different points in time is shown in [Table 1].
Table 1 Uncorrected visual acuity at different postoperative examinations

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Best-corrected visual acuity

The BCVA of the two groups at different points in time is shown in [Table 2].
Table 2 Best-corrected visual acuity at different postoperative examinations

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The mean BCVA of the two groups at different points in time is shown in [Table 3].
Table 3 Comparison between the two groups regarding the mean best-corrected visual acuity

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[Table 4] shows the loss and gain of LogMar lines at the sixth month in all eyes.
Table 4 Loss and gain of LogMar lines at the sixth month in all eyes

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Refraction

The mean spherical equivalent refraction at each examination is shown in [Table 5].
Table 5 The mean spherical equivalent refraction at each examination

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The distribution of spherical equivalent refraction of Cachet eyes and LASIK eyes 6 months after operation is shown in [Figure 1]. The highest change in refraction was between the first-day and 1-week examinations in both groups. The mean change between all examinations in either group was less than 1.00 D. The refractive correction throughout the first 6 months after the two procedures is shown in [Figure 2].
Figure 1 Distribution of spherical equivalent refraction of Cachet eyes and laser in-situ keratomileusis (LASIK) eyes 6 months after operation.

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Figure 2 Refractive correction throughout the first 6 months after the two procedures.

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Corneal endothelial cell count and cell loss

Group 1: The mean preoperative endothelial cell count (ECC) in the Cachet group was 2941.44 ± 145.25 cells/mm2, ranging from 2778 to 3245 cells/mm2. The mean postoperative ECC at 3 months in the Cachet group was 2702.11 ± 132.74 cells/mm2, ranging from 2476 to 2909 cells/mm2. The mean percentage endothelial cell loss in the Cachet group was 8.13% at 3 months. The mean postoperative ECC at 6 months in the Cachet group was 2485.78 ± 157.91 cells/mm2, ranging from 2179 to 2699 cells/mm2. The mean percentage endothelial cell loss in the Cachet group was 8.0% at 6 months.

Group 2: The mean preoperative ECC in the LASIK group was 2817 ± 286.32 cells/mm2, ranging from 2554 to 3123 cells/mm2. The mean postoperative ECC at 3 months in the LASIK group was 2799.67 ± 281.40 cells/mm2, ranging from 2539 to 3098 cells/mm2. The mean percentage endothelial cell loss in the LASIK group was 0.61% at 3 months. The mean postoperative ECC at 6 months in LASIK was 2776 ± 282.45 cells/mm2, ranging from 2520 to 3079 cells/mm2. The mean percentage endothelial cell loss in the LASIK group was 0.84% at 6 months.

The difference between the two groups was not statistically significant (P = 0.330) regarding the preoperative ECC. The difference between the two groups at 3 months was statistically significant (P = 0.417). The difference between the two groups at 6 months was statistically significant (P = 0.044). One Cachet IOL was explanted after 28 months because of severe endothelial cell loss; we performed clear lens extraction for correction of high myopia ([Figure 3]). The specular microscopy of this patient is shown in [Figure 4].
Figure 3 Cachet intraocular lens (IOL) (a) before explantation (b) after explantation.

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Figure 4 The endothelial cell count in the left eye of Cachet patient: (a) baseline, (b) 3 months after surgery, (c) 6 months after surgery and (d) 28 months after surgery.

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Slit-lamp examination

One Cachet eye had transient intraocular hypertension (29 mmHg) caused by incomplete removal of viscoelastic substance, which was treated with oral acetazolamide (250 mg tablets) every 8 h; the intraocular pressure decreased to 14 mmHg in 48 h. By the end of the first week, all Cachet eyes were quiet, with no anterior chamber cells or flare. In one eye (5%), the lens was decentered by 1 mm or less, with the optic of the lens covering the pupil at dim light. The patient did not report night glare.

Intraocular lens position

IOL position was estimated by slit-lamp examination in two ways: (a) incidence of rotation greater than 15° from baseline to any visit through the 6 months visits, and (b) incidence of rotation greater than 15° from visit to visit through the 6 months visits. It showed that the whole eyes had less than 15° IOL rotation from baseline to any visit and from visit to visit through 6 months after surgery.

Position of the intraocular lens in the anterior chamber (AC) over time

The position of the IOL in the anterior chamber, reflected by the distance from the corneal endothelium to the anterior surface of the IOL, remained stable over time, indicating IOL stability. The IOL kept its position in the anterior chamber in all eyes.

Complications and adverse events

In cachet cases

  1. Intraoperative: Pupillary dilatation was noticed in five (25%) eyes after the injection of peribulbar anesthesia. Acetylcholine chloride intraocular solution 1% (Miochol-E) was administered to overcome this dilatation. Difficult loading resulted in unequal wings and asymmetry of the trailing haptics position, which resulted in cutting of the footplates of the IOL in one case. It was managed by pulling the IOL out of the eye and replacing it with another one immediately.
  2. Postoperative: Corneal edema occurred in one case, and this was a localized corneal edema in the central part of the cornea, which was due to the PIOL optic touching the back of the cornea during the unfolding process. It was managed by increasing the frequency of steroids and resolved by the first-week visit. This resulted in a significant decrease in the ECCs at the 3-month visit, which decreased on the 6-month follow-up visits. IOL reflections were noticed by two patients (four eyes), affecting cosmetic appearance with no effect on vision.


In laser in-situ keratomileusis cases

All LASIK eyes were examined 1 h after surgery; two eyes (10%) had displaced flaps, which required flap reposition, and these two flaps had mild edema that resolved within 48 h. One eye had irregular flab; we reposited the flab and postponed the surgery, and the treatment was redone after 3 months with deeper flab. Three eyes (15%) had epithelial in growth: LASIK two eyes were mild and not increased over time that needs no intervention and one eye need intervention as the in growth goes towards the center of the pupil, we elevated the flab, scrub the bed, remove the epithelium and replace the flab. Three (15%) eyes had mild night glair. One eye had decentered ablation that did not affect vision.


  Discussion Top


Refractive and visual outcome

We found improvement of BCVA with PIOL compared with LASIK; this improvement was also reported by other authors. The visual acuity results in the current study are consistent with those achieved by other others [1],[10],[11],[12],[13].

On the contrary, other authors reported different results: Vongthongsri et al. (2004) [14] reported that, in their study on LASIK, the mean spherical equivalent refraction was −7.03 ± 2.39 D, and they found that postoperative UCVA was better than 20/25 in 95.65% of eyes 3 months after LASIK. These results can be explained by the lower degree of myopia (about −7) compared with our study (about −9.14).

Safety

In this study, neither Cachet eyes nor LASIK eyes lost two or more lines of LogMar preoperative BCVA. No Cachet eyes and one LASIK eye lost one line of LogMar preoperative BCVA. These results were equivalent to those of other authors [10],[11],[12].

Other authors reported different results: Vongthongsri et al. [14] found that none of the LASIK eyes lost lines of the preoperative BCVA; 52.17% of eyes gained one line and 13.04% of eyes gained two lines.

De Benito-Llopis et al. [13] found that 6.14% of LASIK eyes lost two lines of BCVA, and 0.87% of LASIK eyes gained two or more lines of BCVA.

Quality of vision was not assessed in the study, as all patients resaved the same procedure in both eyes; therefore, we cannot compare between the two groups, but our results show that there was more gain in lines in the PIOL group than in the LASIK group. The insignificant difference in uncorrected and corrected visual acuity between the Cachet and LASIK groups 6 months after the surgery was not consistent with the statistically significant difference between the final refractive outcome of either group. This can be explained by the fact that the mean preoperative spherical equivalent of the Cachet group (−11.13) was higher than that in the LASIK group (−9.14), and the mean preoperative BCVA of the Cachet group was lower than that in the LASIK group. In addition, LASIK has the advantage of correcting astigmatism, whereas cachet lenses correct only spherical powers. The preservation of the corneal asphericity and the magnification of the retinal image after cachet implantation may explain the significant gain of BCVA in the Cachet group.

Predictability

By the end of the follow-up period (6 months), 19 Cachet eyes (95%) and 15 LASIK eyes (75%) had a spherical equivalent refraction within the ± 1.0 D. These results are consistent with those achieved by other authors [10],[11],[12],[13],[14].

These results show better refractive results with the IOL than with LASIK; this may be because of flap healing, regression, overcorrection, and undercorrection, which may occur with LASIK but not with PIOL.

Endothelial cell count

There was more loss in the ECC in group A. This might be attributed to the damage of the corneal endothelium by direct close contact between the Cachet AC PIOL and the endothelium either during implantation or from postoperative changes in the IOL position with leaning forward, eye rubbing IOL rotation in the AC after surgery. However, the low decrease in ECC in the LASIK group was not related to the surgery, as it is an extraocular surgery and may be because of normal physiological loss.

The ECC observed 6 months after implantation with this angle-supported PIOL was warning and merits ongoing evaluation. However, the loss with LASIK is almost near physiological annual loss.

Important factors in the prevention of postoperative or chronic decreases in ECC are adequate AC depth and appropriate preoperative ECC and IOL sizing, as small-sized IOL may lead to IOL rotation and instability in the AC and touch between the IOL and the endothelium, whereas larger-size IOL leads to more vaulting of the IOL, leading to a decreased distance between the IOL and the endothelium, which may lead to endothelium cell loss over time.

However, interpretation of mean percentage change in endothelial cell density should consider the estimated 0.6% physiological related annual loss [17].

El Danasoury et al. in 2002 [12] found an endothelial cell loss of 0.3% after LASIK.

On the contrary, other authors reported different results on Cachet PIOL: Knorz and colleagues found the mean percentage change in endothelial cell loss of 4.08% at 6 months. They also reported an acute loss (first 6 months) of more than 10% (range = 10.11–57.07% loss) in 10.6% of cases [10]. According to Kohnen and colleagues, there was a loss of 4.77% at 1 year. They also reported an acute loss of more than 10% in 15.1% of cases [15]. Mastropasqua and colleagues reported an endothelial cell loss at the 1-month postoperative visit of −5.5%. They also reported a −4.04% loss at 1 year in their recent study about the AcrySof angle-supported PIOL [11]. Ramon Ruiz and colleagues found at 1 year of follow-up that mean percentage change in central endothelial cell density from the preoperative visit to 1 year after surgery was –6.16 ± 4.29% (ranging from 0 to –13.58%). For most eyes, the mean reduction change was 5% or less (23 eyes of 42) [18]. A study by Schiano Lomoriello et al.[19] found that the mean percentage EC loss preoperatively to 6 months postoperatively was 0.7%. Taneri et al.[16] in 2014 found that the mean percentage ECD loss at 1 month was 2.54% and at 3 months it was 6.24%; they also noticed that the gain in EC count at 1 year postoperatively was 5.5%. Taneri and colleagues were the only others who found gain in endothelial cell number with this IOL; this may be because of the small number of their study (15 eyes) or analysis variability and effects of corneal remodeling in response to the corneal wound healing. Apparent gains in endothelial cell number were reported in different studies and were probably because of analysis variability and effects of corneal remodeling in response to the corneal wound healing [20].

The 6-month mean percentage change in ECC of the Cachet PIOL was higher than the previous studies. This may be because of the high rate of loss (more than 10%) in five eyes (25%), which reaches up to 13% in some eyes.

Intraocular lens position

The PIOL was stable, and our results are consistent with those of other studies [4],[19].

Knorz and colleagues had different results; they found that 67.4% of eyes had less than 15° IOL rotation after surgery and 32.6% had greater than 15° IOL rotation. When IOL position was considered from visit to visit, 14 (71.1%) eyes had less than 15° IOL rotation and six eyes (28.9%) had greater than 15° IOL rotation [10].

Position of the intraocular lens in the AC over time

This study found that the mean distance from the endothelium to the anterior surface of the PIOL at the center of the optic was 2.015 and 2.023 mm at the 3- and 6-month visit, respectively. On the other hand, the mean distance from the endothelium to the anterior surface of the PIOL at its edge was 1.519 and 1.522 mm, respectively. Our results correlate with those of previous studies [4],[11],[19].

The clearance distance between the corneal endothelium and the PIOL is an important factor to reduce the risk of endothelial cell damage. If the distances are stable throughout time, this complication is minimized [21].

The variances in IOL position differences in the 3-month and the 6-month visits were very small. The reason for this slight change might be the accommodation caused by the fixation target on the camera.

This phenomenon was confirmed by Guell et al.[22] who found that there was a significant decrease between the anterior surface of the iris-fixated PIOLs and the endothelium during accommodation.

Complications

Mild night glare in the LASIK group was the most prominent complication in our study. These eyes were more than −9D with an ablation zone of less than 6 mm. We did not face this problem with Cachet IOL. We have nothing to offer for those patients who developed severe night glare after LASIK. This points to the advantages of reversibility that are possible with PIOL but not with LASIK. With Cachet IOL, no incidence of pupillary block, pupil ovalization, retinal detachment, or endophthalmitis was observed. This was consistent with the results of Taneri et al. [16].

Knorz and colleagues, in their study, reported on a patient who had PIOL rotation of 90° 1 day postoperatively; the patient reported that the night glare and haloes had worsened, and had a PIOL explantation. Cataract formation was observed in seven eyes (1.9%) [10]. The results of Kohnen et al.[15] were cataract formation in five eyes (2.6%). One eye (0.5%) had corneal haze because of surgery.


  Conclusion Top


The LASIK procedure was easier, whereas the Cachet implantation was more complex and more stressful for both the surgeon and the patient. We can say that both Cachet lens implantation and LASIK have almost similar efficacy and final refractive outcome in correcting myopia greater than 6.00 D. Better uncorrected and corrected visual acuity, quality of vision, ability to correct higher error, and reversibility are the main advantages of Cachet lens implantation. The main disadvantages of Cachet lens is the high rate of endothelial cell loss, which makes it less safe than LASIK. Further follow-up is needed to investigate the long-term effect of such an IOL on ECC. We recommend not using cachet lens because of the high rate of endothelial cell loss, and yearly endothelial cell density is recommended for the patients who already had this IOL.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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  In this article
Abstract
Introduction
Patients and methods
Results
Discussion
Conclusion
References
Article Figures
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