標籤存檔： Glaucoma

Archway 第三階段試驗 – 使用Ranibizumab的港口藥物傳遞系統對於新生血管相關的老年黃斑變性病症兩年結果

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Created
Tags Retina
Journal Ophthalmology
Status 審查完成
校稿者 蕭靜熹 醫師

Ophthalmology Volume 130, Number 7, July 2023

中文摘要

這篇文章討論了Archway Phase 3試驗的2年結果，該試驗評估了Port Delivery System（PDS）與ranibizumab治療新生血管性老年性黃斑變性（nAMD）。試驗納入了先前接受過抗VEGF治療並有對治療產生反應的nAMD患者。研究發現，PDS組和每月ranibizumab組均報告了特定興趣的眼部不良事件（adverse event of special interest, AESI），其中白內障是最常見的AESI。這些不良事件是可以控制的，並且努力減少了與PDS相關的不良事件。試驗還評估了視覺結果，發現兩種治療方法在最佳矯正視力（BCVA）基準的改變方面基本上是相似的。研究結論是通過PDS連續提供ranibizumab在2年期間對nAMD患者帶來了持續的益處。延長試驗將收集額外的長期資料，覆蓋長達5年的時間

English Abstract

Title : Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results

The article discusses the 2-year results of the Archway Phase 3 Trial, which evaluated the Port Delivery System (PDS) with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD). The trial included patients with previously treated nAMD who had a documented response to anti-VEGF treatment. The study found that ocular adverse events of special interest (AESI) were reported in both the PDS and monthly ranibizumab groups, with cataract being the most common AESI. The AESIs were manageable, and efforts were made to minimize PDS-related adverse events. The trial also assessed visual outcomes and found that the change from baseline in best-corrected visual acuity (BCVA) was generally similar between the two treatment arms. The study concluded that the continuous delivery of ranibizumab through the PDS provided consistent benefits to patients with nAMD over a 2-year period. Additional long-term data up to 5 years are being collected in an extension trial.

Comparison of Optical Coherence Tomography Structural Parameters for Diagnosis of Glaucoma in High Myopia

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Created
Tags Glaucoma
Journal JAMA Ophthalmology
Status 審查完成
校稿者 蕭靜熹 醫師

JAMA Ophthalmology Published online May 18, 2023

中文摘要

這項cross sectional 研究旨在確定在高度近視個體中檢測青光眼最有效的光學相干斷層掃描（OCT）參數。該研究從韓國一家單一醫院招募了高度近視的參與者，包括有和無青光眼的患者。測量了每位參與者的黃斑神經節細胞-內膜層（ganglion cell-inner plexiform layer , GCIPL）厚度、視網膜周圍神經纖維層（retinal nerve fiber layer, RNFL）厚度和視神經盤（optic nerve head, ONH）參數。結果顯示，下側額GCIPL厚度在高度近視患者中區分青光眼眼睛具有最高的診斷效用。該研究建議將temporal raphe sign與單一OCT參數相結合，可以進一步提高在高度近視青光眼診斷的準確性。

English Abstract

This cross-sectional study aimed to determine the most effective optical coherence tomography (OCT) parameters for detecting glaucoma in individuals with high myopia. The study recruited participants with high myopia, both with and without glaucoma, from a single hospital in South Korea. Macular ganglion cell-inner plexiform layer (GCIPL) thickness, peripapillary retinal nerve fiber layer (RNFL) thickness, and optic nerve head (ONH) parameters were measured in each participant. The inferotemporal GCIPL thickness was found to have the highest diagnostic utility for discriminating glaucomatous eyes in patients with high myopia. The study suggests that combining the temporal raphe sign with single OCT parameters may further enhance the diagnostic accuracy for glaucoma in high myopia.

Surgical Results of Trabeculectomy among Groups Stratified by Prostaglandin Associated Periorbitopathy Severity

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Surgical Results of Trabeculectomy among Groups Stratified by Prostaglandin Associated Periorbitopathy Severity

Created
Tags Glaucoma
Journal Ophthalmology
Status 審查完成
校稿者 蕭靜熹 醫師

Ophthalmology Volume 130, Number 3, March 2023

中文摘要

本篇研究的主要目的是探討病人使用Shimane University prostaglandin-associated periorbitopathy
syndrome Grading System (SU-PAP)分級系統，其和青光眼手術（Trabeculectomy）的成效之間是否存在相關性。研究對象為有原發性開放性青光眼、未接受結膜切開手術、完成所有12個月後續追蹤，並利用SU-PAP系統評估其青光眼手術前的病情嚴重程度，共計收集了兩家醫院205例病例，最終納入139位日本患者的眼睛進行分析。研究顯示，手術成果與年齡、性別、手術前眼壓和藥物治療、屈光狀態和是否同時進行白內障手術等因素無關，但是SU-PAP分級系統和手術成效有關。愈厲害的SU-PAP病人的手術成功率較低。研究結果顯示，在進行青光眼手術時，應留意患者的PAP程度，並根據其情況選擇相應治療方式。

English Abstract

The study aimed to evaluate the surgical success rates of trabeculectomy among groups stratified by prostaglandin-associated periorbitopathy (PAP) severity. The Shimane University PAP Grading System (SU-PAP) was used to grade PAP severity among 139 consecutive eyes of 139 Japanese subjects with primary open-angle glaucoma who underwent trabeculectomy between June 2018 and December 2020. The study found that higher SU-PAP grades were associated with lower success rates for intraocular pressure control. Needling, bleb revision, and surgery other than glaucoma were more frequent in patients with higher SU-PAP grades. However, age, gender, preoperative intraocular pressure and medications, refractive error, and simultaneous cataract surgery were not associated with surgical failure. The study suggests that to retain surgical effectiveness, physicians should prevent patients from progressing to severe PAP, an avoidable side effect, by switching or stopping the causative medications. The study also recommends that treating physicians pay attention to patients with severe PAP because it can affect glaucoma management. However, the study acknowledges limitations due to its retrospective design and the potential impact of other glaucoma medications on the results. In conclusion, the study highlights the importance of considering PAP severity when performing trabeculectomy and managing glaucoma.

附註 The SU-PAP grading system classifies the severities of PAP into 4 grades based on the appearance and difficulty performing Goldmann applanation tonometry (GAT).

Grade 0 (no PAP): no prostaglandin-associated cosmetic changes by macroscopic or slit-lamp observation

Grade 1 (superficial cosmetic PAP): the presence of eyelid hyperpigmentation or eyelash growth

Grade 2 (deep cosmetic PAP): the presence of at least 1 of DUES, blepharochalasis
involution, periorbital fat loss, and enophthalmos

Grade 3 (tonometric PAP): difficulty performing GAT or reduced reliability of GAT due to the presence of PAP-related deepening of the upper eyelid sulcus, hardening of eyelids, ptosis, or enophthalmos.

EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure

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EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure

Created
Tags Glaucoma
Journal Ophthalmology
Status 審查完成
校稿者 蕭靜熹 醫師

Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS).

中文摘要

目前測量眼壓的參考技術Goldmann applanation tonometry, GAT在技術訓練及受檢者依賴上有所限制，且不易偵測到真正的峰值和低谷，也無法長期測量眼壓。因此，無法完全掌握眼壓變化，進而影響臨床醫師對青光眼診斷與治療的決策。自我測量眼壓因具有不受受檢者地點與時間的限制，因此，已被提出作為替代方案。文章介紹了一種小型化的眼壓感測器(EYEMATE-SC, implanted in the suprachoroidal space )，它能夠在手持式讀取器的幫助下實現wireless持續性的測量眼壓，以取代現行的眼壓測量技術。透過實驗證明這種感測器經植入後，在12個月的追蹤期間沒有發生裝置移位、翻轉或嚴重的裝置相關併發症。所有病人在使用自我測量的閱讀單元時都被鼓勵在家中定期測量眼壓，並在不同時間進行測量。自我測量的IOP readings對青光眼的患者能夠有效提升治療效果，因此這種新的感測器對青光眼患者的管理和追蹤，以及患者治療效果的評估都有很大的幫助。

English Abstract

The measurement and control of intraocular pressure (IOP) are essential in the treatment of glaucoma. Goldmann applanation tonometry (GAT) is currently the reference technique, but it has limitations due to its dependence on trained personnel and specialized equipment. Telemetric IOP self-measurement offers several advantages over traditional tonometry. The EYEMATE-SC sensor was developed for implantation into the suprachoroidal space, enabling wireless on-demand measurement of continuous IOP values via an external handheld reader. In this first-in-human, prospective, open-label, single-arm, multi-center clinical investigation, 24 patients with primary open-angle glaucoma were enrolled to assess the safety, tolerability, and performance of the EYEMATE-SC suprachoroidal pressure sensor system. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. The overall mean measurement difference between GAT and EYEMATE-SC was 0.8 mmHg, and the 95% confidence interval of limits of agreement was -5.1 to 6.7 mmHg. The EYEMATE-SC sensor was safe and well-tolerated through 12 months, and no serious complications or sensor migration were observed during the follow-up period. These findings suggest that the EYEMATE-SC may provide a reliable and reproducible alternative to traditional IOP measurement techniques.

Effectiveness of Microinvasive Glaucoma Surgery in the United States

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Effectiveness of Microinvasive Glaucoma Surgery in the United States

Created
Tags CGMHOPH Glaucoma
Journal Ophthalmology
Status 已上網
校稿者 黃奕修 醫師

Intelligent Research in Sight Registry Analysis 2013e2019 Shuang-An Yang, MD, MPH,1,2 Elizabeth C. Ciociola, BA,3 William Mitchell, MBBS, MPH,2 Nathan Hall, MSc,4 Alice C. Lorch, MD, MPH,4 Joan W. Miller, MD,4 David S. Friedman, MD, PhD,4 Michael V. Boland, MD, PhD,4 Tobias

Ophthalmology, 2023-03-01, 卷 130, 期 3, 頁面 242-255, Copyright © 2022 American Academy of Ophthalmology

英文摘要

Summary: This study aimed to evaluate the effectiveness of micro-invasive glaucoma surgery (MIGS) with and without concurrent phacoemulsification. In current United States clinical practice, MIGS has substantially lower reoperation rates when performed with phacoemulsification, particularly for endoscopic cyclophotocoagulation (ECP) and goniotomy or canaloplasty. However, the efficacy of these procedures has not been fully demonstrated, as most published studies to date are retrospective series without control groups. Furthermore, little is known about patient factors predicting positive outcomes after MIGS procedures. The results showed that ECP (94%) and goniotomy or canaloplasty (76%) were more likely to be performed with phacoemulsification than ab interno Xen implantation (29%). Lower reoperation rates were observed in patients undergoing MIGS with concurrent phacoemulsification. However, nearly one-quarter of patients undergoing standalone ab interno Xen implantation and goniotomy or canaloplasty required reoperation within two years. Future studies are needed to determine the role of MIGS in different types of glaucoma.

中文摘要

摘要：本研究評估了微創性青光眼手術（MIGS）與是否合併晶状体超声乳化术（phacoemulsification）的有效性。在美國目前的臨床實踐中，與phacoemulsification一起進行的MIGS具有顯著較低的二次手術率，尤其對於內窺鏡下睫狀體光凝固術（ECP）和切口房角手術或管成形術。然而，迄今為止發表的大多數研究都是沒有對照組的回顧性系列，因此尚未充分證明其效能。此外，對於MIGS手術後預測良好結果的患者因素知之甚少。結果顯示，ECP（94%）和切口房角手術或管道成形術（76%）比內窺鏡下Xen凝膠支架植入術（29%）更可能與phacoemulsification一起進行。在MIGS與phacoemulsification聯合進行的患者中，觀察到較低的二次手術率。然而，單獨進行內窺鏡下Xen植入術和切口房角手術或管道成形術的近四分之一患者在兩年內需要再次手術。未來有必要進行更多研究來確定MIGS在不同類型的青光眼中的作用。