Comparison of minimally invasive glaucoma surgery with trabecular micro-bypass stent and microhook ab interno trabeculotomy performed in conjunction with cataract surgery

INTRODUCTION

A first-generation iStent was used, which is a single-piece titanium stent. Using the gonioprism lens to observe the nasal angle, the iStent was put into the anterior chamber approaching the corneal port. For iStent implantation, the iStent was passed through the trabecular meshwork to stay within Schlemm’s canal, at which point it was delivered from its inserter, which was then used to gently press on the implant to seat its heel firmly in the canal (Figure 2).

亞伯是牧羊的，該隱是種地的。有一日，該隱拿地里的出產(chǎn)為供物獻(xiàn)給耶和華，亞伯也將他羊群中頭生的羊的脂油獻(xiàn)上。耶和華看中了亞伯和他的供物，只是看不中該隱和他的供物。該隱就大大發(fā)怒，變了臉色。后來殺了亞伯。(《創(chuàng)世紀(jì)·第四章》)

The effectuality and safety of the iStent-phaco and of μLOT cooperated with cataract surgery (μLOT-phaco) have been reported separately

, but there has been no report comparing the effects of μLOT-phaco and iStent-phaco. Comparison of the iStent-phaco and μLOT-phaco in the right and left eyes of the same patient would allow more detailed examination.In addition, there has been no report regarding to the anterior chamber inflammation in comparison between these surgeries.Therefore, in this study, we performed iStent-phaco in one eye and μLOT-phaco in the other eye of the same patient and evaluated the anterior chamber inflammation and compared the effects and complications of these two MIGS procedures.

SUBJECTS AND METHODS

Ethical Approval This retrospective clinical cohort study was approved by the local ethics committee (St Marianna University School of Medicine Ethics Committee, certificate approval number: 4029) and adhered to the regulations of good clinical practice and the tenets of the Declaration of Helsinki. All patients provided written informed consent for participation in the study.

Study Design Patients underwent cataract surgery (Constellation Vison System: Alcon) cooperated with implantation of an iStent (iStent-phaco) in one eye and excisional goniotomy with the μLOT (μLOT-phaco) in other eye by a single surgeon (Tokuda N) at the St Marianna University School of Medicine, between June 2017 and June 2019. The eye with lower the mean deviation (MD) was chosen for μLOT-phaco.Patients were evaluated preoperatively and again at 1 and 3d,1 and 2wk, and every month up to 1y postoperatively. Each investigation contained assessment of best-corrected visual acuity (BCVA), IOP, and number of ophthalmic antiglaucoma agents used. We delineated failure conforming to the postoperation IOP levels with or without ophthalmic antiglaucoma agents after surgery: ＜20% reduction from the baseline IOP, or IOP＞18 mm Hg.

Patients underwent measurement of the corrected visual acuity using Landolt vision charts. IOP was estimated by Goldmann applanation tonometry. Inflammation in the anterior chamber was evaluated by using the anterior chamber flare (ACF; FC-2000

laser flare meter, Kowa, Japan). Corneal endothelial cell density (ECD) was measured by noncontact specular microscopy (Noncon Robo SP-8000; Konan Medical, Japan).Gonioscopy was carried out before operation and at every postoperative visit to estimate the angle and stent positioning.Data were analyzed using IBM SPSS Statistics 21 (IBM Corporation, Poughkeepsie, NY, USA). Parameters were analyzed using 2-tailed Student’s

-tests and Chi-squared tests,and

＜0.05 were considered statistically significant.

藝術(shù)高校的管理人員要提升對(duì)安全管理工作的認(rèn)識(shí)，引導(dǎo)教師參與到學(xué)生安全監(jiān)管過程中，定期開展相關(guān)內(nèi)容的教育培訓(xùn)活動(dòng)，構(gòu)建長(zhǎng)久而穩(wěn)定的管理機(jī)制，依照法律文件和管理制度落實(shí)工作內(nèi)容，還要加入心理教育的課程，設(shè)立心理咨詢室。安保人員是維護(hù)校園穩(wěn)定的主要組成部分，學(xué)校要加大安保人員培訓(xùn)的投入力度，創(chuàng)建專業(yè)化的安保隊(duì)伍，在校園內(nèi)定期巡邏，尤其要加強(qiáng)夜間的防控，要具備突發(fā)事故處理的素質(zhì)，對(duì)于校園門口和周邊環(huán)境要加強(qiáng)管理力度，還要與當(dāng)?shù)氐墓膊块T配合，避免校園內(nèi)部出現(xiàn)任何違法活動(dòng)［4］。除此之外，宿舍是學(xué)生安全事故的高發(fā)地點(diǎn)，舍務(wù)老師要有安全管理意識(shí)，運(yùn)用柔性手段來代替強(qiáng)制性管理，使學(xué)生自覺遵守、自我監(jiān)督。

Participants The trial enrolled subjects with mild-to-moderate(the Hodapp-Parrish-Anderson visual field criteria:MD≥-6.0 dB, mild; -6.0＞MD≥-12.0 dB, moderate)

open angle glaucoma [containing primary open angle glaucoma (POAG),pseudo-exfoliative glaucoma (PXG), combined-mechanism glaucoma (CMG)] with visually significant cataract who were treated with two or more ophthalmic antiglaucoma agents.The diagnosis of open angle glaucoma was determined by a glaucoma specialist (Tokuda N) conforming to the Japan Glaucoma Society Guidelines for Glaucoma (4

edition)

criteria. Preoperative visual fields were measured using the Swedish interactive threshold algorithm standard 30-2 program of the Humphrey field analyzer (Carl Zeiss-Meditec,Jena, Germany). Eyes were required to have anterior chamber angle grades II-IV (Shaffer classification), where at least the trabecular meshwork was observable by a gonioscope.Additionally, patients had to be aged between 60 and 90y for inclusion in the study. Exclusion criteria included recent(within 12mo) intraocular incisional glaucoma surgery or laser trabeculoplasty and active ocular inflammation, neovascular,traumatic, or angle-closure glaucoma.

截至2016年底，安徽陸續(xù)在省內(nèi)糧棉油主產(chǎn)區(qū)建成投產(chǎn)秸稈直燃發(fā)電項(xiàng)目23個(gè)（凱迪9個(gè)，國(guó)能4個(gè)，光大4個(gè)，華電、中節(jié)能、理昂、大唐等企業(yè)各1個(gè)），其中4個(gè)為新投產(chǎn)發(fā)電項(xiàng)目（理昂郎溪電廠、光大懷遠(yuǎn)電廠、光大定遠(yuǎn)電廠、齊耀阜南電廠），年運(yùn)行總裝機(jī)容量660MW,累計(jì)發(fā)電量約38億kWh，同比增長(zhǎng)31%，發(fā)電設(shè)備年利用小時(shí)數(shù)超過6300h，處于全國(guó)領(lǐng)先水平，建成規(guī)模居全國(guó)第二。核準(zhǔn)在建24座發(fā)電廠，總裝機(jī)700MW，規(guī)模居全國(guó)第一。

The parameters acquired from the subjects comprised patients’ age, sex, eye, preoperative BCVA, MD according to the Humphrey field analyzer, IOP, number of ophthalmic antiglaucoma agents used, ACF, ECD, and glaucoma type.There were no significant differences between the two groups regarding preoperative BCVA, preoperative IOP, number of ophthalmic antiglaucoma agents used, ACF, or ECD. There were more left eyes and men in the μLOT-phaco group than in the iStent-phaco group. The preoperative MD was worse in the μLOT-phaco group (-8.1±3.9) than in the iStent-phaco group(-3.9±2.4;

＜0.01, 2-tailed Student’s

-tests). Figure 3 shows the change in the mean IOP in both groups, from preoperatively to 12mo postoperatively. The mean IOP in both groups decreased significantly from 16.7±2.7 to 13.6±3.0 mm Hg (μLOT-phaco group), and from 16.2±2.2 to 13.6±2.3 mm Hg (iStent-phaco group) by 1mo postoperatively. The IOP reduction was maintained in both groups at 12mo. The mean percentage IOP reduction was not significantly different between the μLOT-phaco group(17.8%±14.7%) and the iStent-phaco group (17.2%±11.3%).The success rate of IOP reduction according to the criteria defined in the study design at 12mo were 80.0% in the μLOTphaco group and 80.0% in the iStent-phaco group, respectively.Figure 4 shows the alteration in the mean number of ophthalmic antiglaucoma agents used in both groups from preoperatively to 12mo after operation. The mean number of ophthalmic antiglaucoma agents used in both groups was significantly decreased from 3.1±0.9 to 0.4±0.5 (μLOT-phaco group), and from 2.8±0.8 to 0.6±0.8 (iStent-phaco group) by 12mo after operation. The decrement in the mean number of ophthalmic antiglaucoma agents in both groups was maintained at 12mo.

In recent years, minimal invasiveness has become a focus point in surgery, including in glaucoma surgery.Minimally invasive glaucoma surgery (MIGS)

does not require conjunctival incision or scleral flap incision that is performed in trabeculectomy. MIGS does not have the same excellent intraocular pressure (IOP) reduction as trabeculectomy. However, MIGS is a safe glaucoma surgery because it does not cause serious complications, including filtering bleb infection

and hypotonic maculopathy

, that are caused by trabeculectomy. MIGS include procedures using a Trabecutome

, 360°

trabeculotomy

,goniotomy with the Kahook Dual Blade

, microhook

trabeculotomy (μLOT)

, and others. In our hospital,μLOT is often carried out in subjects with early to middle stage glaucoma in consideration of efficacy, safety, and cost.

RESULTS

Total, 40 eyes of 20 subjects who underwent μLOT-phaco and iStent-phaco and achieved a minimum of 12mo of followup were comprised in the present analysis. Demographic and preoperative parameters are shown in Table 1.

The μLOT was performed as previously reported

. Viscoelastic material (Healon

Ophthalmic Viscoelastic Substance 1%AMO Japan K.K. Tokyo, Japan) was administered into the anterior chamber approaching corneal ports at the 3 and 10 o’clock locations. Using a gonioprism lens (Swan-Jacob lens,Ocular Instruments, Bellevue, WA, USA), a straight-type Tanito

trabeculotomy hook (M-2215, Inami, Tokyo,Japan) was put into the anterior chamber approaching the corneal port, and the internal wall of the trabecular meshwork was cut open at the temporal and nasal quadrants (Figure 1).

Figure 5 shows the change in the ACF in both groups from preoperatively to 1mo postoperatively. The preoperative ACF value in the μLOT-phaco group was 9.5±3.0 pc/ms and returned to normal by 30d postoperative, with a value of 11.4±3.9 pc/ms. In the iStent-phaco group, the ACF value was 9.6±2.2 pc/ms preoperatively, and it returned to normal by 7d postoperatively (11.2±3.7 pc/ms), and by day 30 it was 9.8±3.5 pc/ms.

Corneal ECD was not significantly different before and after operation in both groups (μLOT-phaco group: 2751.5±159 to 2579.5±419.6,

=0.06, paired

-test, iStent-phaco group:2773.1±225.6 to 2625.5±226.3,

=0.07, paired

-test).Consistent with cataract surgery, the BCVA had improved in both groups, as compared to baseline by 12mo postoperatively.Table 2 lists the surgery-related complications in the two groups. In the μLOT-phaco group, hyphema with niveau occurred in two patients (10.0%) and resolved within 1wk.A transient increase in IOP (defined as IOP＞50% above baseline

) was seen in three patients (15.0%) in the iStentphaco group and in two patients (10.0%) in the μLOT-phaco group. Floaters were noted in 15.0% of the iStent-phaco group and in 10.0% of the μLOT-phaco group. In the iStent-phaco group, one patient had focal peripheral anterior synechiae occlusion of the iStent due to the iris of the iStent, and transient increase in IOP (32 mm Hg) at 1mo postoperatively.In this case, the iStent was found to be tilted toward the iris when observed with a gonioscope after surgery. In addition,three other patients had iStent occlusion, but none of them had increased IOP.

DISCUSSION

In this study, we performed μLOT or iStent implantation procedures in alternate eyes of the same patient, to evaluate the effectuality and safety of these two MIGS, as this intrapatient comparison may reduce the bias caused by individual differences. We found that the iStent and μLOT were both effective through 12mo of follow-up, but the iStent showed to be safer, based on early anterior chamber inflammation.

第三方支付機(jī)構(gòu)面對(duì)的客戶數(shù)量眾多但單筆交易額較小，交易頻率高并且對(duì)于支付成本較為敏感。同時(shí)，由于第三方支付機(jī)構(gòu)的市場(chǎng)地位及培養(yǎng)的客戶支付習(xí)慣短期內(nèi)難以撼動(dòng)，以支付寶為代表的第三方支付機(jī)構(gòu)表現(xiàn)突出。而與第三方支付機(jī)構(gòu)相比，商業(yè)銀行資金實(shí)力較為雄厚，在傳統(tǒng)金融服務(wù)領(lǐng)域占據(jù)優(yōu)勢(shì)，但受到的監(jiān)管限制較多。第三方支付機(jī)構(gòu)雖然創(chuàng)新能力強(qiáng)、創(chuàng)新速度快，但政策環(huán)境并未明朗。因此，雙方若加強(qiáng)合作，進(jìn)一步發(fā)揮各自的優(yōu)勢(shì)，可實(shí)現(xiàn)互利共贏。

The Japanese Guidelines for Use of iStent Trabecular Micro Bypass in Combination with Cataract Surgery

clearly states that the indication of the iStent treatment is: “adult patients with mild to moderate open angle glaucoma (POAG, PEX)with cataracts being treated with antiglaucoma agents”. When surgical procedures were considered based on these guidelines,we decided to perform μLOT-phaco on the eye with the lower MD and iStent-phaco on the contralateral eye. Therefore,preoperative MD was significantly lower in the μLOT-phaco group than in the iStent-phaco group; this may have affected our postoperative results, as discussed below.

娘子關(guān)泉域巖溶地下水主要接受降雨入滲及河流、水庫(kù)等地表水滲漏補(bǔ)給。城市及工礦企業(yè)主要分布于陽(yáng)泉市內(nèi)各河流的中上游地區(qū)，大量污染物隨地表水一起進(jìn)入地下含水層，產(chǎn)生了對(duì)地下水的污染[1]。近年來，陽(yáng)泉市政府在環(huán)境治理方面做了大量扎實(shí)有效的工作，開展了泉域保護(hù)、污水處理廠建設(shè)、垃圾電廠建設(shè)、黑臭水體治理等工作，娘子關(guān)泉域水環(huán)境得到有效改善。

In MIGS, there is also a method for implanting the device in the eye. The iStent

trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA, USA) is used when implanting titanium micro shunts into the trabecular meshwork. The concept of this method is to reduce the IOP by reconstructing the flow of aqueous humor into the trabecular meshwork or Schlemm’s canal by decreasing the resistance of the trabecular meshwork

. The iStent can lower the IOP and decreased reliance on IOP-reducing drugs compared to cataract surgery alone

. The iStent has been approved by the US Food and Drug Administration (FDA) for use only in combination with cataract surgery (iStent-phaco).

Surgical Device and Implantation Technique In both the μLOT-phaco and iStent-phaco groups, the glaucoma surgery was carried out before the cataract surgery.

生態(tài)文明改革成果不僅讓城里人得惠得利，也延伸到鄉(xiāng)下，讓村里人可感可觸。污水處理設(shè)施投入使用以來，全村40多戶村民“污水四處流、坑塘水溝臭氣熏天”的環(huán)境問題得到了解決，有效改善了生態(tài)環(huán)境，提升了群眾的生活質(zhì)量。

With iStent-phaco, we achieved good reduction in IOP and it was possible to reduce the number of antiglaucoma agents postoperatively, as seen in previous reports

. In this study,iStent implantation and cataract surgery were performed simultaneously for all subjects. Therefore, it is necessary to consider that the IOP-reducing effect of the iStent-phaco also includes the IOP-reducing effect of cataract surgery

. In terms of the IOP-lowering effect of iStent implantation alone,Huang

found that the flow of aqueous humor improved after iStent insertion using an enucleated human eye. Shiba

reported that a preoperative IOP of 22.0±3.0 mm Hg decreased significantly to 16.9±3.6 mm Hg by 6mo after surgery in 10 patients who each had two iStents inserted. In terms of the number of iStent insertions, Katz

reported that the rate of control of IOP≤15 mm Hg by 12mo after iStent implantation was 64.9% with only one iStent inserted,85.4% with two iStents inserted, and 92.1% with three iStents inserted. This finding suggests that the IOP-reducing effect of iStent insertion may depend on the number of iStents inserted into the eye. The present study achieved a significant decline in IOP, as compared to before operation, with only lens extraction and implant of a single iStent. Therefore, this surgery may be a useful option for patients with early or middle stage glaucoma with cataracts. Adverse effects of antiglaucoma eye drops on the ocular surface have also been reported

;hence, reducing the number of antiglaucoma agents used after iStent-phaco or μLOT-phaco surgery may lead to improved patient adherence

. In terms of the rate of reduction in IOP,μLOT has an extensive effect on the trabecular meshwork and Schlemm’s canal; it was therefore expected to accomplish a better reduction in IOP than iStent implantation. However,there was no significant difference between the two procedures.The reason for this may be that the iStent-phaco group had less advanced glaucoma than the μLOT-phaco group, so that there was less obstruction of the trabecular meshwork and passage after Schlemm’s canal, thereby allowing a greater IOP-lowering effect. However, this would need to be proved by investigating both procedures in cases with matched stages of progression.

The most remarkable finding in this study was the rapid recovery of the ACF value after iStent-phaco surgery. It took≥14d for the difference with the preoperative value to disappear in the μLOT-phaco group. In contrast, by day 3 after surgery,there was no significant difference from the preoperative value in the iStent-phaco group. This may be related to the minimal surgical invasiveness of iStent-phaco. Tanito

reported that μLOT improves ACF earlier than the EX-PRESS Shunt and trabeculectomy. This result suggests that MIGS causes less inflammation in the anterior chamber than filtration surgery. In the present study, the ACF improved earlier in the iStent-phaco group than in the μLOT-phaco group, implying that iStentphaco is a MIGS that is less likely to result in postoperative inflammation. iStent-phaco may be a particularly helpful option for patients with open angle glaucoma who also have cataracts and want to return to society early after surgery.

Although, the corneal ECD decreased postoperatively in both groups, as compared with the preoperative level, there was a similar degree of reduction to that seen in the divide and conquer technique

, a generally implemented cataract surgery method; therefore, it is unlikely that the μLOT and iStent implantation procedures affected the decrease in corneal ECD.BCVA was significantly improved at the final examination in both groups, and the only influence of μLOT and iStent implantation surgery on postoperative visual acuity loss was due to anterior chamber hemorrhage.

Regarding postoperative complications, hyphema with niveau occurred in 2 patients (10.0%) in the μLOT-phaco group, but no patients developed this condition in the iStent-phaco group.Anterior chamber hemorrhage occurs with μLOT due to the incision made in the trabecular meshwork and Schlemm’s canal. Therefore, hyphema forming niveau in the μLOT-phaco group was not considered an adverse event. The hyphema forming niveau was assumed to have resulted in the transient increase in IOP in one patient, but this resolved within 1wk.On the other hand, three patients in the iStent-phaco group developed transient elevation of IOP (15.0%). Iwasaki

compared the results of a group using Kahook Dual Blade excisional goniotomy and cataract surgery with those of an iStent-phaco group and reported that a transient increase in IOP occurred in 6.8% of the iStent-phaco group. In the present report, there was one case of transient increase in IOP because of incarcerated iris in the iStent-phaco group, and the IOP was reduced by releasing the incarceration with YAG laser irradiation. Shiba

also described transient increase of IOP due to iris incarceration after iStent implantation.Postoperative follow-up and management are important, even with MIGS, where postoperative management is generally easier than with filtration surgery. Salimi

reported the effect of steroid eye drops on the increase of IOP in the early postoperative period after iStent-phaco. We also used dexamethasone instillation for 1mo after all surgeries. There may be a causal relationship between the transient elevation of IOP and the instillation of steroids in the two cases with transient elevation of IOP after iStent-phaco, because the IOP decreased rapidly once dexamethasone was discontinued. The number of floaters was found to be similar in both groups, and this is assumed to be due to inflammatory cells or hemorrhage in the anterior chamber after surgery. Given that all patients underwent lens reconstruction in this study, it is possible that subjective symptoms occurred.

There were some biases in this study, including differences in disease stages between the eyes treated with the two surgical procedures. Additionally, performing cataract surgery concurrently with both surgical procedures meant that the effect of μLOT alone and iStent implantation alone is unknown. It will be necessary to examine disease stages in future studies.

This study compared the early postoperative results of iStentphaco and μLOT-phaco in the same patient. Both methods are considered effective and safe for open angle glaucoma with early to mid-stage concomitant with cataracts. iStent-phaco causes little postoperative inflammation, and is therefore,considered a good option for patients aiming for an early return to work.

ACKNOWLEDGEMENTS

Authors’ contributions: Study concept and design: Tokuda N, Tsukamoto A, Toyoda Y, Yamada Y; Acquisition of data:All authors; Analysis and interpretation of data: All authors;Drafting of the manuscript: Tokuda N, Kitaoka Y; Critical revision of the manuscript for important intellectual content:All authors.

在有效靶點(diǎn)處消融時(shí)，可出現(xiàn)短暫的加速室早或發(fā)生室早成串出現(xiàn)的現(xiàn)象，若持續(xù)放電，則該現(xiàn)象消失。若消融無(wú)效，則需要作更進(jìn)一步的詳細(xì)標(biāo)測(cè)，但不宜進(jìn)行大范圍消融。

Conflicts of Interest: Tokuda N, None; Kitaoka Y, None;Tsukamoto A, None; Toyoda Y, None; Yamada Y, None;Sase K, None; Takagi H, None.

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