Comparison of preoperative simulated and postoperative real safety distances using anterior segment OCT in patients with phakic lOL according to iris configuration

INTRODUCTION

Nowadays, several inclusion criteria have been suggested to preserve endothelial cell count (ECC) after implantations, such as central anterior chamber depth (ACD) greater than 2.8 mm(from endothelium to anterior surface of crystalline lens)

,3.2 mm

or 3.35 mm

, central ECC greater than 2300 cells/mm

,and for myopic artisan endothelial safe distance or peripheral endothelial clearance greater than 1.5 mm

.The peripheral endothelial clearance or safe distance is the distance from the endothelium to the peripheral edge of the iris-claw pIOL. It can be assessed in two ways: preoperatively(simulated safe distance, SSD) using a software that simulates the pIOL before surgery with anterior segment optical coherence tomography (AS-OCT) or Scheimpflug devices

, and postoperatively (real safe distance, RSD) measuring in real time the pIOL in the eye. In some studies, safe distance was measured using the template of the AS-OCT system for preoperative simulation; those studies have shown no significant differences from the preoperative simulation to the corresponding postoperative measurements when the simulator was placed on the middle of the iris tissue, suggesting that pIOL template of the AS-OCT system for preoperative simulation of iris-fixated pIOLs improves the criteria for patient selection

. To the best of our knowledge there is no information about testing the results accuracy in different types of iris configuration.

The implantation of phakic intraocular lens (pIOL)has become a popular surgical technique for

treating refractive errors due to the reversibility of the procedure

,excellent refractive and visual

results

, easy handling of residual postoperative error

, and safety

. Yet, the potential damage for endothelial cells is a major concern in this type of pIOLs; while the normal endothelial

cells loss per year is 0.6%±0.5%

in long-term studies evaluating the efficacy and safety of the Artiflex pIOL, the total endothelial cell loss(ECL) can be considerable, reaching up to 21.5% in 10y postoperatively

. Corneal decompensation has been reported after pIOL implantation, related to the considerable ECL

,likewise, ECL has been reported to be the second cause of explantation of pIOL

.

The purpose of this study is to assess the compatibility between the SSD and RSD in patients with concave, plane and convex iris after pIOLs implantation.

SUBJECTS AND METHODS

This was a prospective, cohort study that included 60 eyes of 60 patients who underwent iris-claw pIOL implantation (Artisan, Ophthec) for surgical correction of myopia at Oftalmosalud Instituto de Ojos, Perú, between July 2016 to July 2018. The study complied with the Declaration of Helsinki. The ethics committee and Institutional Review Board of Oftalmosalud approved the study. Written informed consent was obtained from all patients agree to participate in the study protocol.

Inclusion criteria were ACD greater than 3.2 mm (measured from the corneal epithelium to the lens), stable refraction (less than 0.5 D change in 6mo), endothelial cell density greater than 2300 cells/mm

, mesopic pupil less than 6.0 mm, patient age 18 years or older, no contact lens use, no previous ocular surgeries or laser treatments, no ocular trauma, no corneal abnormalities or other ocular pathologies (dry eye, corneal ectasia, glaucoma, cataract, history of retinal detachment

), and no systemic diseases. If patients had bilateral implantation only one eye randomly selected was included in the study. Preoperatively, all subjects underwent a complete ophthalmologic examination at pre- and 3mo postoperatively including: uncorrected and best corrected distance visual acuity(UCVA and BCDVA respectively), manifest and cycloplegic refraction, slit-lamp evaluation, corneal topography and pachymetry (Galilei G6 Port, Switzerland, software version V6.4.2), specular microscopy (SM-NIDEK CEM-530;Gamagori, Aichi, Japan, software version V1.11.02), optical biometry (IOLMaster 700, Carl Zeiss Meditec AG, Jena,Germany, software version 1.70.12.53128) and AS-OCT(VISANTE model 1000; Carl Zeiss Meditec, Dublin, CA,USA, software version 3.0.1.8). All examinations were performed by the same researcher (Camino-Quezada M). pIOL power calculations were performed using the Van der Heijde formula

. ACD was measured with the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany).

The safety distance was defined as the distance between the edge of the optic to the endothelium (expressed in mm) using AS-OCT Visante software calipers at 45°. Temporal and nasal safe distances were recorded separately. Preoperatively,pIOL simulation was performed using the pIOL template of the AS-OCT system. The Artisan simulator was placed in the middle of the iris tissue and the posterior surface of the haptic was placed halfway between the anterior border of the iris(line passed anteriorly from thinnest portion of iris) and the posterior pigmented epithelium. Using the software calipers,the SSD assessed preoperatively and postoperative RSD(at 1mo postoperative) were measured. All surgeries were performed by the same surgeon (Izquierdo L Jr). Comparisons were performed between the SSD and the RSD for both nasal and temporal sides.

Iris configuration

was measured preoperatively, with AS-OCT Visante at 0°-180° and classified into 3 groups: convex, concave,and plane. As the iris configuration may vary from frame to frame in different image capture, the midpoint between the iris root and the iris tip was selected as the reference landmark, in order to reduce the measurement variability of iris bowing

Iris bowing was defined as the perpendicular distance from the iris pigment epithelium to a midpoint between the iris root and the iris tip.

If the measurement line coincides with the horizontal line from the scleral spur to the scleral spur with the pigment epithelium of the iris (Figure 1A) the iris was considered as plane; if the line of measurement was posterior to the iris pigment epithelium (Figure 1B), the iris bowing was considered as positive, and the iris was convex. If the line of measurement was anterior to the iris pigment epithelium(Figure 1C), the iris bowing was considered as negative, and the iris was concave

. All examinations were performed by the same researcher.

按照個人所得稅法有關規(guī)定，農民進城務工勞務所得、經營所得、工資所得等，收入達到個稅起征要求也需要繳納個人所得稅，如月工資、薪金超過5000元需繳納個稅，勞務報酬每次超過800元需繳納個稅等。但是進城務工人員工作相對不易，與城鎮(zhèn)居民納稅人又承擔相等的納稅義務，稅負較重，進城后生活狀況改善有限，整體公平性并未實現。

ECC had a significant decrease in all groups, Table 4 shows the mean decrease in ECC in each group; it was 305.6±348.4,197.2±185.9, and 204.8±192.9 μm in the concave, convex and plane group respectively.

RESULTS

The average patient age was 31.75y (range 20-46y). There were 24 males (40%) and 36 females (60%). Table 1 shows the preoperative and postoperative data of the studied population.According to preoperative evaluation, there were 26.6%(16/60), 18.33% (11/60), 55% (33/60) eyes in the concave, convex and plane group respectively. Preoperative temporal SSD was 1.79±0.37 mm and postoperative RSD was 1.55±0.31 mm(

＜0.001). Preoperative nasal SSD was 1.75±0.38 mm and postoperative RSD was 1.48±0.29 mm (

＜0.001).Mean difference between temporal SSD and RSD was-0.36±0.37, -0.14±0.38, and -0.24±0.33 mm in the concave,convex, and plane groups, respectively. Mean difference between nasal SSD and RSD was -0.36±0.38, -0.29±0.48,and -0.18±0.30 mm in the concave, convex, and plane groups, respectively. Statistically significant differences between SSD and RSD (for both nasal and temporal) were found in the concave and plane groups. Table 2 shows preand postoperative safe distances for each group and Figure 2 shows SSD and RSD in a patient with concave iris, in which nasal postoperative RSD was 120 μm lower than preoperative SSD and temporal postoperative RSD was 210 μm lower than preoperative SSD.

思維的無意識性是指思維活動大多是無意識的(Thought is mostly unconscious)。依照這一原則，人類大腦中大多數思維活動是在無意識狀態(tài)下進行的，有意識的思維活動只是偶爾的現象。傳統(tǒng)英美分析哲學認為所有思維活動都是有意識的，體驗哲學認為這種說法是與思維現實完全不符的臆想。

Table 3 shows the lower coefficient of correlation of concordance found for all groups, meaning that SSD change after pIOL implantation. Figure 3 shows Bland Altman plots for the differences between the SSD and RSD in eyes with iris concave, plane and convex respectively.

The R version statistical package 3.4.1[Freely available software under the terms of the Free Software Foundation’s General Public License (https://www.r-project.org/)] was used for the statistical analysis. For the comparison of independent groups, the Kruskal-Wallis test was used. The Dunn test was used for multiple comparison tests after the Kruskal-Wallis test, differences were considered statistically significant at a

value ＜0.05.

DISCUSSION

According to the European Multicenter Study of Artisan pIOL

and to the U.S. Food and Drug Administration Ophtec Study

, the rate of ECL after iris-claw pIOL implantations is not significantly different from the normal ECL of 0.6%per year

. However, recent studies with long term follow up showed a significant loss of endothelial cells 2.9% to 9.1% at 6y, and 12% at 10y after pIOL implantations

. ACD is one of the main factors in central ECC decay after anterior chamber pIOL implantations

.

Peripheral endothelial clearance can be assessed pre- and postoperatively; preoperatively (SSD) using a template that simulated the future position of the pIOL. Studies have been conducted to test if the software or template is effective in predicting the postoperative peripheral RSD with different results. Doors

used the Visante AS-OCT system in 60 eyes for preoperative simulation, they placed the pIOL simulator in the middle of the iris tissue and found that the measured edge distances were significant smaller in the preoperative simulation than in the postoperative images.Fallah Tafti

, using AS-OCT compared preoperative simulation versus real postoperative measurements after irisfixated pIOL using two different techniques for positioning the template: in one the simulator was placed on the posterior pigmented epithelium of the iris and in the other the simulator was placed in the middle of the iris tissue and found that only when the simulator was placed in the middle of the iris tissue the results were not statistically different from the corresponding postoperative measurements. These differences could be a result of not only the localization of the pIOL template over the iris (middle versus posterior), but also due to the iris configuration of the patients.

In our study we implemented the technique of placing the simulator on the middle of the iris, in which no differences were found between pre- and postoperative evaluation as Fallah Tafti

suggested, however, we found that SSD overestimated the RSD in 0.26 mm (range 0.14-0.36 mm).Significant differences were found between preoperative SSD and RSD for both nasal and temporal sides in eyes with iris concave and plane.

In 2006, Ba?koff

proposed that the minimum safe distance between the edge of the optical zone of the pIOL and the endothelium, as measured by AS-OCT, should be greater than 1.5 mm to minimize the risk of ECL. In fact, in myopic Artisan pIOL, the peripheral endothelial clearance or safe distance seems to be more important than the ACD because the thickness of iris-fixated pIOLs differs according to their power

.

通過大數據智能分析出的數據，可以為企業(yè)設計人員提供用戶所需要的設計元素，例如分析用戶群體的年齡、消費能力、消費興趣等，推測用戶最需求的金融服務[8]。為設計者提供新的設計思路，使設計出的產品更具有針對性，更加滿足用戶的使用需求，甚至目前很多金融產品可以實現用戶自行設計購買方案，十分便捷。靈芝系統(tǒng)就是相對于普適性的信用評價系統(tǒng)，采用更多的數據類型，對于特殊類型的企業(yè)和個人進行獨特的數據分析，獲得更加有針對性的數據和結果，不但能夠有效地進行風險防控，也能以此為根據設計更加符合其消費傾向的金融產品，以獲得更加廣闊的市場。

隨著人們生活水平的提高，腦卒中偏癱患者對后期康復和生活質量改善的需求也日益增多，雖然在住院期間患者能夠享受較完善的護理服務，但出院后由于醫(yī)療條件和環(huán)境限制，其后續(xù)的護理需求難以保障。延續(xù)性護理通過對出院患者提供以人為中心的全方位整體護理，可滿足偏癱患者出院后的護理需求。

14.拓展創(chuàng)新公證服務民營企業(yè)工作。監(jiān)督指導公證機構認真辦理企業(yè)并購、招標投標、知識產權、拍賣、提存、抵押等公證業(yè)務，加大對中小企業(yè)融資貸款的公證服務力度，規(guī)范交易行為，防范非法集資風險，維護民營企業(yè)的合法權益。積極開展公證服務知識產權保護，圍繞“一帶一路”建設等國家重大戰(zhàn)略，推動建立“一帶一路”沿線國家和地區(qū)公證服務知識產權保護合作機制。在有條件地區(qū)開展民營企業(yè)公證服務知識產權保護試點，遴選培育第二批若干家公證服務知識產權保護示范機構。

Considering that significant statistical differences were found only in the plane and concave iris groups, and not in the convex iris group, we can hypothesize that our results are associated with the behavior of the iris when the pIOL is implanted.Thus, we believe that in cases of plane or concave irises, the traction created by the pIOL can change the position of the iris to be more anterior. This phenomenon could not happen with a convex iris because it has an anterior configuration. Our results show a greater change in the concave iris group than in the plane iris group; safe distance was reduced in the plane iris group by -0.18±0.30 and -0.24±0.33 mm in the nasal and temporal sides, whereas in the concave group the safe distance was reduced by -0.36±0.38 and -0.36±0.37 mm in the nasal and temporal sides, reinforcing our hypothesis. Also, despite all groups had significant decrease on ECC, the group with higher amount of decrease was observed in the concave group followed by the plane group and the convex group.

Our study has some limitations: the caliper for RSD measurements was placed manually. However, the same operator performed all measurements and followed the same measurement criteria(45 degrees) to minimized errors in the measurements. Also,our study has a small sample size. We are collecting more data for subsequent analysis. However, our results show that the SSD assessed preoperatively by AS-OCT can be overestimated in patients with concave and plane iris configuration and this must be taken in consideration when forming an inclusion criterion for pIOL implantation. We recommend surgeons to be aware of the SSD in this group of patients and evaluate the RSD in the short postoperative follow-up.

黃炎培沒有聽雷震的，又去找國民參政會的一些同事如傅斯年等人反映，爭取他們的同情和支持，防止此事不了了之。

Presented in part as a Paper at American Academy of Ophthalmology, San Francisco, October, 2019.

We thank Jose Chauca, MSc, for the statistical analysis and Carmen Maldonado, MSc, for technical support.

None;

None;

None;

None.

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