Visian Implantable Collimating Lens Results | OPTH

2021-11-25 10:18:55 By : Ms. Kelly Xiao

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Back to Journal »Clinical Ophthalmology» Volume 15

Visual effect, foot plate position and vault obtained by using Visian implantable collimator to treat myopic astigmatism

Author Reinstein DZ, Vida RS, Archer TJ 

Published on November 20, 2021, the 2021 volume: 15 pages 4485-4497

DOI https://doi.org/10.2147/OPTH.S330879

Single anonymous peer review

Editor who approved for publication: Dr. Scott Fraser

Dan Z Reinstein, 1–4 Ryan S Vida, 1 Timothy J Archer 1 1 London Vision Clinic, London, UK; 2 Columbia University Medical Center, New York, New York, USA; 3 Sorbonne University, Paris, France; 4 Coleraine, UK Address: Dan Z Reinstein London Vision Clinic, 138 Harley Street, London, W1G 7LA, UK Tel 44 207 224 1005 Fax 44 207 224 1055 Email [email protected] Purpose: The report is highly used Frequency (VHF) digital ultrasonic sizing results of implantable collimating lens (ICL) in myopic astigmatism. Methods: 42 consecutive ICL surgeries using EVO and EVO (Visian V4c) lenses (STAAR Surgical) were analyzed. Use the ultrasound-based Kojima formula and Insight 100 VHF digital ultrasound (VHFDU) to select the ICL size. Use 3-month data for standard visual result analysis, which also includes contrast sensitivity, refractive and corneal vector analysis, and ECC. VHF digital ultrasound was used to assess postoperative lens position. Result: The tried SEQ is-10.83 ± 3.39D (- 4.40 to-16.98D). The cylinder is-1.46 ± 1.15D (0.00 to-4.25D). 86% of the eyes were followed up for one year, and 96% of the eyes were followed up for 3 months. 89% of eyes had a UDVA of 20/20 or better after surgery, compared with 71% before surgery. The postoperative SEQ refractive power was ± 0.50 D in 74% of eyes and ± 1.00 D in 98% of eyes. 43% of the eyes have a 1-line CDVA increase, 10% of the eyes have 2 or more lines, and 7% of the eyes have a line loss, and none of the eyes lose 2 or more lines. The vector average of corneal SIA is 0.24 D Ax 100. The contrast sensitivity showed a statistically significant increase, with an average increase of 0.14 log units at 6, 12, and 18 cycles per degree (P <0.01). The average change of ECC is -153±353 cells/mm2. The lens dome is 506 ± 233 μm (114– 924 μm). The foot plate is inserted at 48.3% of the band position, 49.2% of the ciliary body and 2.5% of the gingival sulcus. Conclusion: ICL implantation has high safety and effectiveness, but the implant vault range will be improved under ideal conditions. The relationship between the VHF digital ultrasound of the lens footplate and the posterior anatomy can provide important information for evaluating the abnormal value of the fornix after surgery. Key words: implantable collimator lens, ICL, phakic intraocular lens, foot plate, VHF digital ultrasound

The V4c implantable collimator lens (ICL) (STAAR Surgical, Monrovia, CA) has been proven to provide effective subjective and objective visual results, and has a low complication rate for patients with various refractive errors. 1-5 The most important safety parameter is the lens separation, the distance between the ICL and the natural lens, usually called the dome. Low vault is related to early cataract formation, 3,6, high vault is related to increased intraocular pressure, pigment dispersion and glaucoma. 7,8 The introduction of the "aquaport" central hole is believed to reduce the risk of postoperative cataract formation in ICLs with low domes, although this has not been reported in the long term. 9

The ICL size algorithm recommended by the manufacturer uses external anatomical landmarks to predict the fit of the ICL behind the iris. The manufacturer provides an online calculator that requires input of horizontal white-to-white diameter (WTW) data obtained by diagnostic equipment or manual calipers, 10 plus anterior chamber depth (ACD), corneal curvature, and refractive power. Many reports indicate that ICL users may use optical coherence tomography (OCT) or simulated ultrasound biomicroscopy for internal measurements to improve the poor correlation between external eye landmarks and internal posterior chamber anatomy and size. 11-17 Most notably, Dougherty et al. 11 and Kojima et al. 14 published the size formula for handheld UBM measurement based on the posterior chamber size, and Nakamura et al. 15, 18 developed an OCT-based anterior chamber (scleral puncture to sclera -Branch line) diameter and angle to the angle of the lens rise. Both Dougherty and Kojima formulas use a posterior chamber groove-to-sulcus (STS) measurement based on an analog handheld UBM. The Dougherty formula also includes the ICL refractive power to be implanted, while the Kojima formula also includes ACD and groove-to-groove lens lift (STSL).

Hand-held UBM equipment provides iris imaging, including posterior pigment epithelium, and posterior iris structures that are not visible to optical diagnostic equipment, such as sulcus, ciliary body, lens zonules, and peripheral lens surfaces that are usually within the scan range. The frequency range is about 25 –35 MHz. Artemis Insight 100 (ArcScan Inc, Golden, Colorado) very high frequency (VHF) digital ultrasound scanner provides robotic scanning control, including infrared imaging of the eye during reverse water bath eyecup immersion scanning to locate higher resolution B -Use a short pulse broadband 60 MHz probe to scan the anterior chamber image, including the anatomical landmarks of the posterior chamber. 16,19,20

The purpose of this study is to report the comprehensive treatment results of using V4c EVO and EVO ICL based on Artemis Insight 100 VHF Digital Ultrasound (VHFDU) scanning and Kojima formula based on handheld scanning to determine lens size.

This is a retrospective analysis of continuous ICL surgery performed by a surgeon (DZR) using EVO and EVO (V4c) lenses in the treatment of myopia or compound myopic astigmatism at the London Vision Clinic from April 2017 to January 2019. As part of the London Vision Clinic's routine clinical care protocol, informed consent was obtained from patients before surgery and permission to use their data for general auditing, analysis, and anonymous release. As a retrospective study, the UK Health Research Agency received an exemption approved by the Institutional Review Board. The study complies with the principles of the Declaration of Helsinki.

One of the in-house optometrists conducted a comprehensive inspection. The complete diagnostic test protocol is shown in Table 1. Explicit optometry is carried out in accordance with a standardized protocol to push the maximum positive and maximum cylinder. All optometrists have received optometry training and verification under this protocol. 21 For patients found to be inappropriate for corneal refractive surgery, phakic intraocular lens surgery is recommended as an alternative vision correction option. The patient then returns for a second informed consent visit for further discussion and repeats the optometry with the surgeon for ordering ICL power through the manufacturer's online surgical calculation and ordering system (OCOS™). Table 1 Diagnosis and inspection schedule

Table 1 Diagnosis and inspection schedule

Perform a VHFDU scan to obtain the front and back dimensions for size determination. Before surgery, Verion image guidance system (Alcon Laboratories, Inc., Fort Worth, TX) was used to perform iris registration image acquisition on all eyes, regardless of astigmatism, to ensure the horizontal placement of the main temporal incision. The ICL size was selected based on the posterior chamber imaging of Artemis Insight 100 VHFDU, which was operated by a technician in the clinic. The ICL preoperative scan set includes scans of 0, 3, 6, 9, 351, 354, and 357 degrees, with a total of 7 horizontal meridians. Each patient needs at least 2 sets of scans to provide at least 14 images to assess the level of the posterior chamber bioassay, of which the 4 best images of each eye are used for the bioassay. All VHFDU scans are evaluated and analyzed by an observer (RSV). Use software calipers to measure the anterior chamber angle (ACA), ACD, STS and STSL in the Insight 100 system, as shown in Figure 1. Figure 1 Ultrasonic B-scan using Insight 100 (ArcScan Inc, Golden, CO). The red caliper line shows the measured anterior chamber depth (ACD), groove-to-sulcus (STS), and lens ascent from the groove plane (STSL). Other dimensions that can be measured from this scan include anterior chamber angle, angular diagonal (ATA), internal ciliary diameter (CBID), zonules to zonules (ZTZ), and lens ascent from the zonule plane (ZTZL)).

Figure 1 Ultrasonic B-scan using Insight 100 (ArcScan Inc, Golden, CO). The red caliper line shows the measured anterior chamber depth (ACD), sulcus to sulcus (STS), and lens ascent from the sulcus plane (STSL). Other dimensions that can be measured from this scan include anterior chamber angle, angular diagonal (ATA), internal ciliary diameter (CBID), zonules to zonules (ZTZ), and lens ascent from the zonule plane (ZTZL)).

The recommended lens size in the Dougherty11 size nomogram is derived using STS and lens power. The recommended lens sizes in the Kojima14 size nomogram are derived using STS, STSL and ACD. The lens sizes recommended on the STAAR OCOS website are derived using WTW, lens power and ACD. The lens size selected for surgery is based on the islet formula.

The closest usable lens power is selected according to the age-adjusted target postoperative hyperopia spherical surface. Among them, the target spherical equivalent of 21 years old is 0.66 D, and the 42-year-old person linearly drops to the flat surface. Patients over 45 years old use the micro-single vision solution. After proper preoperative tolerance testing, the target sphere of the dominant eye is a flat surface, and the myopia of the non-dominant eye is closest to -1.50 D. If available for the required lens power, use E​​VO lenses, otherwise use E​​VO. All procedures are performed in a single eye, with at least 2 days between the first eye (non-dominant eye) and the second eye (dominant eye). In all cases, perispheric anesthesia was used. The implantation is performed through a 3.2 mm temporal incision placed according to the Verion image guidance system, which is also used to optimize the alignment of the astigmatism axis during the operation. Before leaving the operating room, use mydriatic at the end of the operation. A postoperative check was performed immediately 1 hour after the operation to ensure adequate intraocular pressure and seamless sutures to seal the wound.

The patient was asked to wear a plastic protective cover during sleep for 7 nights. Tobramycin and dexamethasone (Tobradex: Alcon, Fort Worth, USA) and Moxivig (Moxivig: Novartis Pharmaceuticals UK Ltd, London, UK) were applied four times a day during the first week, and moxifloxacin was applied for 3 weeks Broad-spectrum prevention. The surgeon re-examined the patient 1 day and 3-5 days after the operation, and the in-house optometrist examined the patient during the 1-month, 3-month, and 12-month visits. Table 1 summarizes a complete set of postoperative tests and measurements.

The OCT was used to analyze the size of the central fornix of ICL and the anterior chamber angle induced by ICL. The anterior chamber angle analysis was performed on the nasal angle and the temporal angle (horizontal meridian). The lens touch and foot pedal position were also evaluated using VHFDU. Use SP-3000P mirror microscope (Topcon, Tokyo, Japan) to perform endothelial cell count changes.

The result analysis is based on the standard chart of refractive surgery reports including astigmatism. 22 If available, use 1-year follow-up postoperative data for analysis, otherwise use 3-month data. Eyes whose refractive power is not expected to be emmetropic after surgery (partially corrected patients) are excluded from the efficacy analysis (only). As described by Alpins, a vector analysis is performed on the refractive cylinder, and the 23-cylinder axis is reflected in the vertical meridian of the left eye. The stability analysis of the equivalent spherical refractive power and refractive cylinder, and the average simulation of corneal curvature and corneal astigmatism were performed on MS39 (CSO Italia, Florence, Italy). The Alpins ISRS calculator (www.isrs.org/resources/assort-group-analysis-calculator) was also used for vector analysis of corneal astigmatism to evaluate astigmatism caused by corneal incision surgery. The Student's t-test is used to calculate the statistical significance of any change in logarithmic contrast sensitivity. Microsoft Excel 2010 (Microsoft Corporation, Seattle, WA, USA) is used for data entry and statistical analysis. A p value of <0.05 was defined as statistically significant.

During the study period, 42 eyes of 21 patients met the inclusion criteria for the analysis. The last follow-up was 36 eyes (86%) for 12 months, 4 eyes (10%) for 3 months, and 2 eyes (5%) for 1 month. Table 2 shows the demographic data of the study population, which includes a wide range of age, equivalent spherical refractive power, and cylindricity. Table 2 Demographics

In the study population, 32 eyes (76%) had corneas classified as normal, and 4 eyes (10%) had keratoconus (FFKC), which was defined as having corneal changes associated with early keratoconus but no CDVA Loss, and 6 eyes (14%) were classified as mild to moderate keratoconus (KC), which was defined as corneal changes and reduced CDVA (Table 2).

Table 3 shows the lens parameters and the size of the anterior and posterior chambers before surgery. Twenty eyes (52%) used 12.6 mm lenses, and 22 eyes (48%) used 13.2 mm lenses. 31 eyes (74%) used EVO lens. Table 3 ICL parameters and anterior chamber size

Table 3 ICL parameters and anterior chamber size

Figure 2 shows the standard chart for reporting refractive surgery. 89% of eyes had a postoperative UDVA of 20/20 or higher, and 71% had a preoperative CDVA of 20/20 or higher. The spherical equivalent accuracy is within ±0.50 D in 74% of eyes, and within ±1.00 D in 98% of eyes. 43% of the eyes have an increase in the CDVA line, 10% of the eyes have 2 or more lines, and 7% of the eyes have a loss of 1 line, and none of the eyes have lost 2 or more lines. Figure 2 Nine standard graphs report refractive surgery showing the visual and refractive effects of 42 phakic intraocular lens treatments using Visian V4c implantable implantable lens (Staar Surgical, Monrovia, CA). Abbreviations: UDVA, uncorrected distance vision; CDVA, corrected distance vision; D, diopter; postoperative, postoperative; preoperative, preoperative; SEQ, spherical equivalent refraction; TIA, target-induced astigmatism; SIA, surgery-induced Astigmatism.

Figure 2 Nine standard charts for reporting refractive surgery, showing the visual and refractive effects of 42 phakic intraocular lens treatments using Visian V4c implantable collimator lens (Staar Surgical, Monrovia, CA).

Abbreviations: UDVA, uncorrected distance vision; CDVA, corrected distance vision; D, diopter; postoperative, postoperative; preoperative, preoperative; SEQ, spherical equivalent refraction; TIA, target-induced astigmatism; SIA, surgery-induced Astigmatism.

Table 4 shows the equivalent spherical refractive power, refractive cylinder and MS39 mean corneal curvature and corneal astigmatism before and 3 to 12 months after surgery. As shown in Table 4, the average spherical equivalent refractive power at 3 months was -0.07±0.30 D, at 1 year it was -0.19±0.36 D, and the average change was -0.12 D, although this was not statistically significant (P=0.063) ). This change is not due to corneal changes, because the average corneal curvature remains stable between 3 and 12 months (P = 0.523). Table 4 The stability of spherical equivalent refractive power and SimK corneal curvature measurement

Table 4 The stability of spherical equivalent refractive power and SimK corneal curvature measurement

Figure 3 shows the refractive cylinder vector analysis of the eye implanted with toric lenses. The main results are shown in Table 5. The scatter plot of Surgical Induced Astigmatism Vector (SIA) and Target Induced Astigmatism Vector (TIA) shows that the diopter cylinder correction has reached the target in terms of magnitude. The angle error histogram shows that the refractive correction is accurately placed on the expected meridian of most eyes, with 97% errors within ±15°. Table 5 Vector analysis of refractive column and corneal astigmatism Figure 3 The vector analysis of refractive column shows the polar plots of target-induced astigmatism vector (TIA), surgical-induced astigmatism vector (SIA), difference vector (DV) and correction index (CI).

Table 5 Vector analysis of refractive column and corneal astigmatism

Figure 3 Refractive cylinder vector analysis shows the polar coordinates of target-induced astigmatism vector (TIA), surgical-induced astigmatism vector (SIA), difference vector (DV) and correction index (CI).

Figure 4 shows the vector analysis of corneal astigmatism. The vector average of corneal SIA is 0.24 D Ax 100, and the arithmetic average is 0.35 D. This is related to an induced change of 0.15 D in the amplitude of corneal astigmatism (P = 0.413), as shown in Table 5. Corneal astigmatism remained stable between 3 and 12 months (P = 0.732), indicating that there was no further change after the initial surgery-induced changes. A subgroup analysis of eyes with spherical lenses found that the similar arithmetic mean was 0.39 D, but the vector mean was 0.08 D Ax 123. Figure 4 The surgically induced astigmatism vector (SIA) of corneal astigmatism is displayed as a dual-angle vector diagram (DAVD) (A) and a polar diagram (B). The vector mean and standard deviation ellipses are displayed on DAVD. These charts were generated using the ISRS Alpins ASSORT calculator.

Figure 4 The surgically induced astigmatism vector (SIA) of corneal astigmatism is displayed as a dual-angle vector diagram (DAVD) (A) and a polar diagram (B). The vector mean and standard deviation ellipses are displayed on DAVD. These charts were generated using the ISRS Alpins ASSORT calculator.

Table 6 includes the intermediate contrast sensitivity data before and after surgery, showing that at 6, 12 and 18 cycles per degree, an average increase of 0.14 log units (equivalent to a patch on CSV-1000) is statistically significant. (P <0.01). A small increase of 0.04 log units at 3 cycles per degree was not statistically significant (P=0.287). For each frequency, the contrast sensitivity of only 2 eyes (5%) is reduced by more than 0.25 log units. Table 6 Contrast sensitivity

According to MS-39 OCT measurement, the average ±SD lens vault at one month time point is 506±233 µm (range: 114–924 µm). Due to the size being too large or too small, there is no lens to justify the early ICL replacement procedure. A sub-analysis of ICL foot plate positioning was performed on 30 eyes (71%), and VHFDU scans were available at 3 months. The position of all 4 foot plates for each patient was evaluated (120 foot plates in 30 eyes). In this subgroup, the foot plate is located directly in front of the zonules, curved toward the gingival sulcus at 58 locations (48.3%), and inserted into the ciliary body (ciliary body insertion) at 59 locations (49.2%). ), and then directly inserted in 3 positions (2.5%) into the groove (groove position). VHFDU enables us to ensure that under physiological conditions, there is no contact between the ICL and the lens of any eye, including ICL lenses with very high myopia, where the thickest part of the ICL is located at the middle edge behind the iris, so OCT B scan imaging is not visible . Examples of different pedal positions can be seen in Figure 5. Figure 5 Ultrasonic B-scan using Insight 100 (ArcScan Inc, Golden CO) shows the position of the ICL pedal. (A) shows that the foot plate just before the zonules is bent toward the groove (the zonules position). (B) Shows the foot plate inserted directly into the ciliary body (the ciliary body position). (C) shows the foot plate directly into the dental groove (sulcus position), accompanied by the tilt associated with the lens.

Figure 5 Ultrasonic B-scan using Insight 100 (ArcScan Inc, Golden CO) shows the position of the ICL pedal. (A) shows that the foot plate just before the zonules is bent toward the groove (the zonules position). (B) Shows the foot plate inserted directly into the ciliary body (the ciliary body position). (C) shows the foot plate directly into the dental sulcus (sulcus position), accompanied by the tilt associated with the lens.

Use OCT for preoperative and postoperative anterior chamber angle analysis. The analysis was performed at 0° and 180°. The average preoperative angle was 42±7° (range: 28-65°). The average angle at 1 month after surgery was 24±4° (range: 12-29°).

Table 7 includes the ECC data before and after the operation, showing an average change of -153±353 cells/mm2 (range: -1238 to 639 cells/mm2), which is statistically significant (P=0.014). Among the 36 eyes with ECC data before and after surgery, 5 eyes (14%) measured endothelial density decreased by more than 500 cells/mm2, and 2 eyes decreased by more than 1000 cells/mm2 (5%). Except for the loss of more than 1000 cells/mm2 in 2 eyes, the postoperative ECC of all eyes was greater than 2100 cells/mm2. ECC remained stable from 3 to 12 months (P=0.290). Table 7 Endothelial cell count

One eye that was measured as losing more than 1000 cells/mm2 underwent a lens replacement 1 month after the first treatment, and the EVO lens was replaced with an EVO lens (larger lens), as described in detail below. The second eye that lost more than 1,000 cells/mm2 underwent a complete case review and an in-depth review of the surgical video. The fit of the syringe through the main incision is very tight, requiring more manipulation. However, the rest of the treatment is conventional, including lens injection and placement.

Since the tail pedal in the loading box was captured and torn when ICL was injected, a spare lens was used in 1 eye. The ICL was taken out of the cartridge and a spare lens was installed. The operation proceeded smoothly without complications.

The patient's first eye complained of obvious night vision glare under dim lighting after the operation, so a lens replacement procedure was performed. The use of brimonidine 0.1% drops reduced the glare, but after consultation and discussion, the patient chose to change the ICL from EVO to EVO (same lens size) 6 weeks after surgery. Six weeks later, EVO was implanted in the second eye without complications.

During the 12 months postoperatively, 4 eyes (3 patients) developed mild anterior uveitis at the 1 month visit. The intraocular pressure of two eyes (one patient) also increased (42 mmHg in the right eye and 34 mmHg in the left eye). The increase in pressure was properly managed, and normality and stability were rechecked. Patients who need to change ICL from EVO to EVO prefer to use diluted pilocarpine (0.5%) eye drops as needed to reduce nighttime halos caused by negative photosensitivity in some cases.

In this study, we found that the results of refractive and visual acuity are accurate and safe, especially considering the correction of high myopia (spherical equivalent refractive power up to -16.98 D), the relative reduction of preoperative CDVA, and the inclusion of anterior refractive and refractive power. Patients with keratoconus. Overall, for emmetropic eyes, the postoperative UDVA was 20/20 or better, and 25% of the eyes had 71% more eyes than those with 20/20 or better CDVA before surgery. The spherical equivalent refractive power is within ±0.50 D in 74% of eyes, and within ±1.00 D in 98% of eyes. These refractive and visual results are similar to the previously published series. 24-28

The decrease in endothelial cell count density after ICL implantation is well documented, and there are no clinically significant changes in the short-term and long-term. 29-31 ECC analysis of the current population showed similar findings, with an average change of -153 ± 353 (range: −1238 to 639) over 1 year. Of the two eyes that lost more than 1000 cells/mm2, one eye had a lens replacement at 6 weeks, while the other eye was believed to be related to a tighter ICL syringe fit. To date, there are no publications describing the impact of the ICL exchange procedure on endothelial cell counts. This is an area where further investigation and publication can be done.

Anterior chamber analysis showed that the anterior chamber angle was expected to decrease between preoperative and 1 month postoperative visits. The average preoperative angle was 42°, and the average postoperative angle was 24°. This is similar to Li et al.32, who reported that the average preoperative angle of 147 eyes was 47.37° (at 3 o'clock) and the average postoperative angle was 27.56°. Further analysis is needed to determine whether the angle change should be considered as a safety parameter when choosing ICL.

Although there were no obvious intraoperative or postoperative complications, during the 1-month follow-up, a patient had a steroid-induced increase in intraocular pressure in both eyes. It has been reported that excessively large ICL sizes and narrowed angles can lead to an increase in IOP and glaucoma. However, the dome is 415 µm in the right eye and 350 µm in the left eye. The anterior chamber angle measured by OCT after both eyes was greater than 20°.

It is generally believed that the most important safety factor for phakic intraocular lens implantation is related to the size of the ICL. For all eyes in the current study, the ICL size is selected based on the VHFDU measurement value imported into the Kojima formula. The Dougherty formula selected the same ICL size for 32 out of 42 eyes and STAAR OCOS™ website calculator for 18 out of 42 eyes. 23 out of 42 eyes (54%) used an ICL one size smaller than the recommended lens size of STAAR OCOS™, and 1 out of 42 eyes (2.4%) used a lens size smaller than the recommended lens size of STAAR OCOS™ The number one ICL.

The average ± SD lens vault in the current population is 506 ± 233 µm (range: 114 to 924 µm, 95% confidence interval 457 µm). There is no ICL in the series of 42 consecutive eyes that need to be replaced in advance because the size is too large or too small. Dougherty et al. 11 used the VuMax-II high-frequency 35 MHz sector scanning probe (Sonomed Inc., Lake Success, NY) to report an average value of 340 ± 174 µm (range: 90 to 952 µm, 95%) ± SD arch The confidence interval for the top 72 eyes is 341 µm). Kojima et al.14 used the same VuMax-II high-frequency 35 MHz sector scanning probe and reported that the average dome of their 47 eyes was 640±250 µm (range: 190 to 1330 µm, 95% confidence interval 490). The average error ± standard deviation between the actual and predicted vaults is -0.06 ± 290 µm (95% confidence interval 568 µm). Given that the Kojima formula was used for the size measurement in this study, the average postoperative vault is similar to the Kojima report14, which is expected. Given the use of trench-to-ditch dimensions, it is not surprising that our vault average is also similar to that reported by Dougherty. 11 We are currently investigating the vault prediction capabilities of other posterior chamber dimensions, including the internal diameter of the ciliary. The comprehensive analysis of the lens size and the derivation of the ultrasonic-based size formula are the subject of future research.

The population of this study monitored the lens touch and the position of the foot plate through VHFDU postoperatively, and there was no foot plate, peripheral optical edge, or peripheral contact lens. The ICL with higher myopia has a thinner optical center and a thicker optical periphery, so the central lens dome does not actually represent the smallest distance between the lens and the ICL. Direct monitoring of postoperative lens separation behind the physiological (non-dilated) iris can only be performed by ultrasound scanning.

Anatomically placing the foot plate may affect the variability of the lens dome of a particular eye. In the current population, nearly half (48.3%) of the footplate exhibited the lowest zonule position, slightly less than half (49.2%) of the ciliary body position and 2.5% of the higher groove position. Zhang et al33 evaluated the tactile position of the foot plate and ICL in 134 eyes and found that there were also variability. The foot plate was 21.6% in the ciliary sulcus, 2.2% in the top of the ciliary body, 12.7% in the ciliary process, and The inferior ciliary body was 10.4%, and it entered the ciliary body at 32.1%. Their analysis also showed that the lens may have a combination of two or more of these (ie, a foot plate at the top of the ciliary body and a foot plate below the ciliary body). In the current population, it is found that 6/30 (20%) has a combination of two or more pedal positions. Considering that a higher lens dome is associated with more anterior insertions, this may be reasonable, so if the surgical technique is to ensure posterior placement, this may have an impact on the variability of the lens dome.

All in all, the visual results of ICL EVO and EVO ICL V4c models are very effective and safe in this type of eye. Using Artemis Insight 100 VHF digital ultrasound, combined with the Kojima lens size formula, produced similar results. The scattering in the lens dome (114-924 µm) is slightly smaller than the Kojima study (190-1330 µm). 14 The slight reduction in scattering may be attributed to the higher resolution 60MHz ultrasound scanning probe. Larger population studies will provide more information about this result. Although the eyes do not need to be replaced immediately due to size issues, the lowest and highest arched eyes may need to do so in the future. It is hoped that the predictability of the lens library can be further improved to avoid these outliers, so as to achieve a long-term guarantee. Further research on the anatomical features of the posterior chamber may improve the predictability of the achieved lens fornix, as well as the standardization of implant technology to ensure consistent touch and foot plate placement, should improve the predictability of the ICL size, reducing or possibly Eliminate size-related complications.

This work was carried out at the London Vision Clinic. No external funding was received for this work.

Dr. Reinstein is an employee of the London Vision Clinic; a consultant to Carl Zeiss Meditec (Carl Zeiss Meditec AG, Jena, Germany) and owns Artemis technology (ArcScan Inc, Colorado) through patents managed by the Cornell Technology Enterprise and Commercialization Center (CCTEC) State Golden), Ithaca, New York. Dr. Archer is an employee of London Vision Clinic and reports on manuscript writing/employment costs. The authors report no other conflicts of interest in this work.

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