Efficacy of haptic sutured in-the-bag intraocular lens for intraocular lens-capsule complex stability: a comparison of three insertion methods

INTRODUCTION

In eyes predisposed to intraocular lens (IOL) dislocation due to zonular insufficiency, devices such as standard and modified capsular tension rings (CTR) with transscleral fixation through the ciliary sulcus are used to add stability of IOL-capsule complex during cataract surgery

. Recently, late in-the-bag IOL subluxation or dislocation due to zonulolysis has been reported with increasing frequency and has been reported as 0.2% to 3%

.

Risk factors for postoperative IOL dislocation include pseudoexfoliation syndrome, prior vitreoretinal surgery, history of trauma, long axial length, uveitis, retinitis pigmentosa, and connective tissue disorders, such as Marfan syndrome

.Certain measures to prevent IOL-bag complex luxation have been proposed in these predisposing eyes: postoperative relaxing cuts of anterior capsulorhexis margin with Nd:YAG laser, intraoperatively, aspiration of cortex directed in a tangential fashion, and preference of a 3-piece hydrophobic acrylic IOL which may reduce continuous curvilinear capsulotomy (CCC) shrinkage through a combination of decreased anterior capsule fibrosis and greater haptic rigidity than a single piece IOL

.

The primary objective of this study was to evaluate the anatomical stability of IOL capsular bag complex; CCC area contracture, CCC shape and IOL tilt. And the secondary objective was to evaluate the resultant refractive stability,refractive change, and ACD.

據(jù)介紹，6月份，哈國家磷肥廠宣布投資80億堅戈(約合2200萬美元)用于現(xiàn)代化改造，預計到2020年擴大磷肥產(chǎn)量至50萬噸，遠期目標為100萬噸。今年1～8月，該廠的產(chǎn)品主要銷往美國、中國、阿富汗、俄羅斯、烏克蘭、塔吉克斯坦和烏茲別克斯坦。同時，哈產(chǎn)氮肥已開始向阿根廷、羅馬尼亞、捷克、保加利亞和伊朗出口。

At risk eyes with zonular insufficiency may require transscleral suture fixation which is utilized for both transscleral fixation of IOLs as well as endocapsular supporting devices, such as modified CTR and capsular anchoring devices

.

微網(wǎng)逆變器的VSG轉(zhuǎn)動慣量和阻尼系數(shù)自適應控制//溫春雪,陳丹,胡長斌,樸政國,周京華//(17):120

SUBJECTS AND METHODS

Institutional Review Board (IRB)/Ethics Committee approval of St. Vincent’s Hospital was obtained(VC21RISI0078). All research was conducted in accordance with the tenets of the Declaration of Helsinki.

A retrospective cohort study with 60 eyes was performed using records of 60 patients undergoing cataract surgery between January 2015 and May 2020 at St. Vincent’s Hospital. Surgeries were performed by one surgeon (Cho YK).Inclusion criteria for patients consisted of 50 or more years of age, clinically significant cataracts with zonular instability,less than 120° (4 clock hours) of zonulolysis, and over 1y of postoperative follow up results. Zonular instability was determined preoperatively by the presence of phacodonesis with or without visible zonular dehiscence in full mydriasis and intraoperatively by marked difficulty in performing the CCC due to lens movement with the presence of zonular dehiscence less than 4 clock hours detected under the operating microscope. Intraoperatively just before IOL insertion, the extent of zonulolysis in clock hours was measured with corneal radial marker with degree gauge. The eyes with phacodonesis in performing the CCC as well as eyes with visible anterior or posterior capsular wrinkling or centripetal movement of anterior capsular margin less than 120° were regarded as eyes with zonulolysis less than 4 clock hours.

The refractive change between 1mo and 1y for Group 1 was 0.71±0.02 D and showed significant hyperopic change compared to 0.37±0.15 D for Group 2 (

=0.009), and 0.05±0.05 D for Group 3 (

=0.007). There was no significant difference in refractive stability between Groups 2 and 3(Figure 6A).

Surgical patients underwent one of three techniques for IOL (YA60BBR

, Hoya Corp., Tokyo, Japan) insertion(Figure 1) by surgeon’s preference according to the operative situation, such as patient’s cooperation including eye movement, hearing ability, availability of CTR, and reimbursement of medical insurance. Group 1 (IOL in the bag) utilized a three-piece IOL inserted in the bag with haptics oriented toward the areas of zonulolysis. Group 2(IOL with CTR in the bag) had a three-piece IOL inserted after injection of a 12 mm standard CTR (Ophtec, Groningen,The Netherlands). Group 3 (Haptic sutured IOL in the bag)received a three-piece IOL inserted in the bag with novel scleral suture fixation at optic-haptic junction.

下面我們將從國務院及其下屬部門，如國家發(fā)展和改革委員會、科技部、工業(yè)和信息化部、財政部、中國人力資源和社會保障部、自然資源部、生態(tài)環(huán)境部、水利部、農(nóng)業(yè)農(nóng)村部、商務部、國家衛(wèi)生健康委員會、國家市場監(jiān)督管理總局等各個部委發(fā)布的政策、新規(guī)、通知等方面來總結(jié)一下在2018年我國都出臺了哪些政策法規(guī)。

At postoperative 1mo and 1y follow-ups,refractive change, anterior chamber depth (ACD), IOL tilt, and CCC were obtained and compared between groups. Refractive changes (reported as spherical equivalent) were measured using an autorefractor keratometer (RK-F1, Canon, Japan).ACD was measured as the distance between the central corneal anterior surface and the anterior surface of the IOL using A-scan ultrasound (AVISO, Carl Zeiss Meditec Ag, France).Negative and positive values between that of preoperative and postoperative 1-year ACD results indicate forward or backward axial movement of the IOL.

With sufficiently dilated pupils, IOL position was measured using the Oculus Pentacam (Oculus Optikger?te, Inc., Germany).These measurements were performed by an ophthalmic technician who was blinded to patient IOL insertion method.Two vertical Scheimpflug images of total 25 cross section of the target eye 90° apart were selected, and the mean value of tilt in perpendicular directions was recorded as IOL tilt.

山東威海海洋經(jīng)濟發(fā)展示范區(qū)的主要任務是發(fā)展遠洋漁業(yè)和海洋牧場，傳統(tǒng)海洋漁業(yè)轉(zhuǎn)型升級以及與海洋醫(yī)藥、生物制品業(yè)融合集聚發(fā)展模式創(chuàng)新。日照海洋經(jīng)濟發(fā)展示范區(qū)則是推動國際物流與航運服務創(chuàng)新發(fā)展，開展海洋生態(tài)文明建設(shè)示范。

The line between the anterior chamber angle (red line in Figure 2B) and the line between the IOL edges (yellow line in Figure 2B) were marked on imaging. The IOL tilt angle between red line and yellow line was measured using the reference line of Scheimpflug image (dotted line in Figure 2A and 2B).

Two aspects of CCC contraction, shape and area, were measured. The shape was evaluated by calculating the CCC axis balance. An ellipse was drawn from the outer tangent lines of the CCC margin and the shortest axis (X axis) and the vertical, longest axis (Y axis) of the ellipse were measured. The axis balance of CCC was calculated (length of X axis ×100%/length of Y axis) and describes the similarity between axes as a percentage. A percentage of 100% denotes a perfect circle, and a smaller percentage nearing 0 denotes a flatter, ovoid shape due to CCC contraction (Figure 3).

從區(qū)域分布上看，內(nèi)蒙古地區(qū)“草原絲綢之路”可分為西部段和東部段兩部分。西部段以呼和浩特、烏蘭察布、包頭、鄂爾多斯為重要支點，向西經(jīng)寧夏、青海與新疆絲綢之路相連；東部段由呼倫貝爾、通遼、赤峰等重要節(jié)點城市為依托，連接著俄羅斯、蒙古國，是通往歐洲絲綢之路的重要通道。

SPSS Statistics for Windows software(version 11.5, SPSS Inc, Chicago, IL, USA) was used for the statistical analysis. An analysis of variance test was applied to compare data between Groups, and a post hoc analysis was performed when statistical differences were noted between visits.To compare the causes of zonular dehiscence and postoperative 1-year PCO according to each group, the Chi-square test and Fisher exact test were used, respectively. In all cases, a

value less than 0.05 was considered statistically significant.

The cause of zonular dehiscence was determined by retrospective chart review including history taking, tonometry, slit lamp examination and visual field test.

Here, we describe a simple technique involving a modification to the IOL haptic suture fixation locations. The efficacy of this technique to maintain capsular bag stability was then compared with two other traditional methods, namely, in-thebag IOL insertion with haptics oriented toward areas of zonular dehiscence and in-the-bag IOL insertion with a standard CTR.

After local anesthetization (sub-tenon injection of lidocaine) and sterile draping, the procedure begins with an anterior CCC approximately 5.0-6.5 mm in diameter using a capsule forcep. In eyes with severe phacodoensis,capsular stability was maintained using disposable iris hook(Synergetics

O’Fallon, MO, USA) placed at the anterior capsular margins. Iris hooks were used in eyes with poor mydriasis. Next, routine phacoemulsification cataract surgery was performed and IOL insertion was accomplished by one of three methods. Group 1 receive a three-piece IOL alone with haptics oriented toward areas of zonulolysis, and Group 2 received CTR coimplantation. The novel method used in Group 3 was performed as follows: After irrigation and aspiration and injection of viscoelastics into the capsular bag and prior to IOL insertion, a 10-0 polypropylene double-armed suture was inserted at the 2 and 8 o’clock position (or the 4 and 10 o’clock position) according to the direction of zonulolysis,about 2 mm from the limbus, and docked in a 30-gauge needle in the anterior chamber. The 10-0 polypropylene suture was retrieved through the main incision and cut in half. Next, each end of the polypropylene suture was tied near the three-piece IOL optic-haptic junction. The IOL, now with both haptics tied with polypropylene sutures, was then inserted into the capsular bag. The opposite end of the polypropylene suture was placed through a trans-scleral tunnel, tied, and adjusted (Video 1,online supplementary).

The posterior capsular opacity (PCO) at postoperative 1-year follow up were measured using slit lamp microscopic examination according to the grading by Congdon

as follows: absent (Grade 0), no opacity or opacity limited to the peripheral capsule; Grade 1, any wrinkling or opacity of the capsule affecting a circle 4 mm in diameter and centered on the visual axis ; Grade 2, central/paracentral opacity as described above sufficient to degrade details of the macula slightly;Grade 3, central/paracentral opacity as defined above, but sufficient to make ascertainment of the cup/disc ratio difficult;Grade 4, central/paracentral opacity as defined above, but sufficient to make visualization of fundus details difficult or impossible.

RESULTS

Table 1 shows the preoperative demographics of three groups.At postoperative 1mo, there was no difference between groups in comparison of IOL tilt, axis balance of anterior capsulotomy area and the percentage area of anterior capsulotomy compared with total corneal area (Figure 5).

Exclusion criteria were congenital zonular laxity (

, Marfan syndrome), previous ocular surgery, intraoperative posterior capsule rupture, greater than 2.00 D of corneal cylinder by keratometry, abnormal corneal topographic patterns, and extreme axial length (less than 21.0 mm or longer than 25.0 mm).

For ACD changes between 1mo and 1y, Group 1 (0.40±0.05 mm) showed a significant ACD increase compared to Group 3 (-0.04±0.01 mm,

=0.005). There was no significant difference in ACD change between Group 2 (-0.07±0.01 mm)and Group 3 (Figure 6B).

As for IOL tilt, Group 2 (2.66°±0.11°) showed significantly less IOL tilting than Group 1 (6.35°±0.28°,

=0.005) and Group 3 (3.47°±0.11°,

=0.006). Group 3 showed significantly less tilt than the Group 1 (

=0.007; Figure 6C).

Comparing of shapes of CCC, Group 2 (93.13%±1.00%)showed the largest axis balance (the least disparity), and Group 3 (64.13%±0.55%) showed the largest disparity between X and Y axis (Figure 6D). For change in area due to CCC contraction,Group 1 (21.62%±1.06%) showed significant CCC contraction compared to the Group 2 (1.00%±0.52%,

=0.005) and Group 3 (6.32%±1.36%,

=0.007). Group 2 showed less CCC contraction than Group 3 (

=0.010; Figure 6E).

Comparing of PCO, there was no eye with PCO Grade 3 or above. There was no difference of PCO incidence between groups (Table 2).

As a result, Group 3 showed the superior anatomical (CCC area, IOL tilt) and refractive stability (ACD, refraction) to Group 1 and showed superior anatomical stability (CCC area,CCC shape, and IOL tilt) to Group 2.

DISCUSSION

Given the rising prevalence of pseudophakia due to increased life expectancy and earlier surgical intervention for cataracts,the incidence of late in-the-bag IOL dislocation may increase over time

. Surgeons need to consider preoperative risk factors and various surgical techniques to prevent this dangerous complication.

大部分國家和地區(qū)的教師開展教學活動時，比較依賴教材的探究活動。這就對教材中探究活動的實用性提出了較高要求。情境的創(chuàng)設(shè)是十分重要的，建議多創(chuàng)設(shè)學生感興趣的真實情境，甚至有關(guān)地理原理和過程的學習也可以結(jié)合真實情境展示。

Cataract surgery in the presence of zonulysis can make the surgery difficult, and it is not uncommon for surgeons to miss zonulysis less than 4 clock hours preoperatively due topoorly dilated pupil or a subtle phacodonesis. In eyes with microscopically visible zonulysis found during surgery,surgeons must determine the appropriate location and IOL insertion methods according to the extent of zonulysis.

CTRs can serve to support the capsular bag during surgery and provide long-term IOL stabilization

. The centrifugal force that CTR creates at capsule equator can maintain tension and the circular contour of the capsular bag

. However,CTRs carry a risk for iatrogenic damage to capsular bag with insertion

.

Typically, CTRs are utilized in cases of mild, diffuse zonular weakness or small, localized zonular dialysis (

, less than 4 clock hours). When the degree of zonular dehiscence is 120°or greater, however, the stability of IOL-capsule-CTR complex cannot be guaranteed

.

SPO主要用于矢狀面脊柱畸形的矯形［6］，冠狀位亦適用［7］，由于截骨不多，SPO適用于畸形程度輕的患者。據(jù)報道，SPO治療側(cè)凸角度＜ 70°，柔韌性＞ 40%的脊柱畸形都能獲得滿意效果［8］。對于矢狀位偏移（SVA）6 ～ 8 cm的患者，推薦應用SPO［9］。SPO技術(shù)風險較小，操作相對簡單［10］，對于不能熟練開展三柱截骨手術(shù)的年輕脊柱外科醫(yī)師是第一選擇。

For large areas of zonulysis, surgeons generally cannot insert IOLs without special devices with sutured fixation, such as modified CTRs or capsular tension segments. In situations where special devices are lacking, insertion of IOL into the sulcus with scleral fixation is the traditional approach to zonulysis confronted during cataract surgery.

With respect to refractive stability, Group 1 (IOL in the bag)showed significant hyperopic changes compared to Group 2 (IOL with CTR in the bag) (

＜0.01) and Group 3 (haptic sutured IOL in the bag) (

＜0.01). This finding signifies greater ACD deepening from capsular contracture and subsequent posterior movement of the IOL in Group 1. In our study,Group 2 showed superior stability in all parameters (refraction,anterior chamber depth, CCC contracture, and IOL tilt) than Group 1.

The CCC area was measured using Image J software as the percentage area of the CCC in reference to the total corneal area. The total corneal area was defined as the area contained by the corneal limbus (Figure 4A). CCC contraction was then calculated by subtracting the percentage areas obtained at the two postoperative visits at 1mo and 1y.

In contrast to our results, one study on co-implantation of CTR showed hyperopic change in eyes with CTR compared with eyes without CTR

. Belov

compared refractive outcomes in myopic eyes between IOL implantation with and without a CTR, and found no statistically significant difference in the mean absolute refractive prediction error between the CTR group and controls. These results may be due to differences in the total follow up period and inclusion criteria of each study as our study included eyes with zonulysis of less than 120°. The capsular contraction syndrome itself can cause postoperative hyperopic change, due to posterior bowing of IOL-capsule complex

.

But we assume that the difference in refractive changes in each study depends on the degree of zonular weakness with accompanying progressive changes with time. Moreover, CTR cannot entirely prevent capsule contraction

.

When considering IOL tilt, Group 2 showed less tilt than Group 1. These results concur with a study by Lee

,who evaluated the impact of the CTR on postoperative IOL position using Scheimpflug imaging and found that eyes with both an IOL and a CTR had significantly lower anatomic IOL decentration and physical tilt than eyes with IOLs alone.

However, the opposite was reported. Page

found the use of CTRs caused an increase in tilt aberration after cataract surgery and does not seem to improve the optical performance of conventional IOL after uneventful cataract surgery. In a study of Takimoto

, there was no reported difference in IOL tilt between the CTR group and control at 6mo postoperatively. The observation period of these two studies were different from ours, so further long-term study may provide a better understanding of postoperative IOL tilt.

通過CT或者MRI對110例患者進行了排查，確定都為腦梗塞患者，其派出的標準為認知功能缺陷患者、生活無法自理者以及心肝腎等功能障礙患者[1]。

Group 3 showed comparable ACD and refractive stability to Group 2. This is notable because an effective sutured haptic technique may offer additional advantages over CTR-based methods as this novel technique can be done without special devices, such as the modified CTR. Sutured haptic IOLs would also resist late IOL-capsular bag dislocation that pose a risk to standard CTR co-implantation.

Considering the significant complication such as extension of a zonular dialysis, violation of the capsular bag, displacement of the CTR into the vitreous, misplacement into the sulcus,or the anterior chamber which might occur during CTR implanatation, this novel technique can be an alternative choice for eyes with zonular insufficiency

.

目前如何定義慢加急性肝衰竭（ACLF）在國際上存在很大分歧，影響國際間的交流。分歧的核心主要有兩大方面，一是肝臟基礎(chǔ)疾病究竟應該包括哪些；二是急性打擊是否必須有肝臟功能的衰竭，且衰竭的界定標準是什么 [1-2]。世界胃腸病組織（WGO）提出的ACLF概念試圖融合東西方的差異，將不同肝臟基礎(chǔ)疾病全部納入，同時提出分類管理，即A型ACLF-非肝硬化型 （A型）；B型ACLF-肝硬化代償型 （B型）；C型 ACLF-肝硬化失代償型（C型）[3]。我國最常見的是HBV-ACLF[4-5]，本文將探討此分類在我國患者中的應用價值。

When using CTR, if the zonulopathy is a non-progressive zonulopathy, such as traumatic or iatrogenic zonular dialysis,these cases are well suited for standard CTR, as the remaining zonules are typically of normal tension. In cases of progressive or advanced zonulopathy, such as advanced pseudoexfoliation syndrome, a standard CTR is unlikely to provide the capsular support needed, and will most likely allow the IOL to dislocate postoperatively

. The modified Cionni CTR can prevent the late IOL-capsular bag dislocation, but this Cionni CTR needs scleral fixation, too. So with suture related problems and iris chafing exist with using the Cionni rings

. This novel,haptic sutured in the bag IOL technique can be used safely in progressive zonulopathy.

In all postoperative values (ACD, refraction, CCC area, IOL tilt) except CCC shape, Group 3 showed significantly superior stability than Group 1. When analyzing Group 3’s CCC shape(axis balance), we found the suture point of optic-haptic junction has the potential to elongate the long axis (Y axis),creating a CCC shape that may be more ovoid than those of the other groups.

A well-known technique for IOL insertion in the setting of zonular dehiscence is orienting IOL haptics toward the area of zonulysis. The IOL haptics will extend the capsule in the direction of zonulysis and help maintain the CCC shape. In our study Group 1 was shown to maintain a more circular shape than Group 3. However, using an IOL alone appeared to poorly resist CCC contraction as the CCC contraction was highest in this group.

控制措施：①正確選用焊接材料。②按照工藝要求，焊前預熱，冬季施工時采取保溫措施，必要時進行焊后加熱緩冷。③嚴格控制組對應力，避免強力組對。④避免其他焊接缺陷的產(chǎn)生，如：未焊透、長條狀夾渣、咬邊等。⑤選擇經(jīng)驗豐富、技術(shù)高、責任心強的焊工進行根焊作業(yè)。根部焊道焊接時，由2名或3名焊工從兩側(cè)對稱焊接，一旦出現(xiàn)缺陷，不允許進行返修，須切掉重焊。⑥焊接過程中可在上爬坡最容易焊接操作的位置留一段(100～200mm)不焊，便于焊接過程中觀察焊道內(nèi)部的焊縫成形情況，發(fā)現(xiàn)有質(zhì)量問題可及時解決，同時有利于焊道在焊接過程中的應力釋放，以減小焊道根部裂紋的產(chǎn)生，待其他地方根焊道全部完成后再把預留處焊完（見圖6）。

This novel technique we introduce here involves a modification to the IOL fixation location. Historically, scleral suture fixation

of IOLs is accomplished by suturing IOL haptics at one-third from each end (or through premade holes in the haptics) followed by insertion into the sulcus with or without optic capture. In this novel technique, we modified the location of sutures in the IOL haptic to be nearer to the optic-haptic junction to facilitate insertion of the IOL easily into the bag

.Additionally, the CCC was made larger than the usual optic size of a commercial three-piece IOL (typically 6.0 mm or less), so the fixation knot point on the haptic will be minimally affected by the capsulorhexis margin.

Because we included only cases of less than 4 clock hours of zonulysis, we did not perform or include cases of traditional scleral sulcus fixation, which is more appropriate for case of larger zonulysis. This study was further limited by its retrospective nature and lack of randomization in choice of IOL insertion methods.

Although the traditional scleral sulcus fixation technique with or without optic capture was not included, we believe this novel technique of in-the-bag haptic sutured IOL will prove to be superior in several regards (a manuscript in preparation).

Our approach preserves anatomical stability of the IOLcapsular bag complex with both optic and haptics in the bag.Retaining the haptics in the bag can stretch the capsular bag(especially toward the direction of zonulysis) according to the total length of the planned IOL. In traditional sulcus scleral fixation methods, total capsular phimosis or bag shrinkage or bag distortion can be caused by an absence of the IOL haptics in the bag

. This technique can also prevent total capsular phimosis or bag shrinkage due to an absence of the IOL haptics as seen in traditional scleral sulcus fixation.

3b 1H NMR(CDCl3) δ:8.23-8.21(m,2 H),7.75-7.71(m,1 H),7.58-7.55(m,1 H),7.36-7.27(m,2 H),7.08-7.03(m,2 H),3.87(s,3 H).

In conclusion, the in-the-bag haptic sutured IOL technique can improve the IOL-capsular bag complex stability without additional devices. This easy and simple technique we introduce here has the potential to play an effective role in preventing late IOL decentration in eyes at risk, such as those with partial zonulysis or phacodonesis.

證明 類似地，獨占暫存性離散資源分配的最優(yōu)方法應該滿足極大相容公理組ESCA4，即要求分配方法滿足{Ax.4,Ax.5,Ax.6,Ax.7}.

None;

None;

None.

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