Placebo Effect and Its Determinants in Ocular Hypotensive Therapy

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眼壓降低治療中的安慰劑效應及其決定因素

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

本摘要旨在探討安慰劑對眼壓降低治療的潛在作用及影響因素。研究的主要結果是基於4週的治療所得到的效應值。通過統計分析選擇合適的元分析，並使用95%置信區間進行比較。多重元回歸模型被用來分析潛在的安慰劑效應決定因素。結果顯示，附加研究設計和較大樣本量與較大的安慰劑效應有關。研究還表明，在青光眼治療中，安慰劑效應可能引起免疫抑制反應，從而減少腎臟T細胞移植。然而，眼壓降低藥物中的安慰劑效應尚未量化，這使得對青光眼眼壓降低治療的有效性進行客觀和無偏見的結論變得困難。此外，本研究的結果還表明，安慰劑在降低眼壓方面的臨床效應超過未經治療。然而，本研究也存在一些限制，包括部分受試者對接受治療的態度不明確的影響因素等。因此，在評估眼壓降低治療的有效性和健康經濟分析以及樣本大小計算時，這一事實應該得到考慮。

English Abstract

The text discusses the placebo effect in ocular hypotensive therapy for glaucoma treatment. The study aims to determine the effectiveness of the placebo in glaucoma treatment and the factors influencing its effect. The research used a meta-analysis approach with statistical pooling and multiple meta-regression analyses to explore the determinants of the placebo effect. Findings suggested that add-on study design and larger sample size were associated with a greater placebo effect, and there was no evidence of publication bias. Despite the extensive literature on placebo effects, this study is the first to systematically analyze the effect of placebo in ocular hypotensive therapy. The limitations of the study include a small number of untreated control trials and the use of study-level variables in the regression analysis. This study provides valuable insights into the placebo effect in ocular hypotensive therapy, emphasizing the need for further research to understand its clinical implications.

Evaluation of the Consistency of Glaucomatous Visual Field Defects Using a Clustered SITA-Faster Protocol

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使用聚集SITA-Faster協議評估青光眼視野缺陷的一致性

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

這篇文章是關於使用前載(frontloading) SITA-Faster (SFR)視野測試來評估青光眼的病變。作者通過進行2次測試以及使用集群測量策略，借助24-2 SITA-Faster (SFR)範式測試協議，以確定前載SFR每眼進行2次測試是否提供了任何附加有用的數據。文章發現，前載SFR測試可以提供重複的全局和點對點數據，並在持續時間和可靠性方面與單次SS測試相當。該方法可能有助於增加測試頻率/數量，以滿足青光眼進展分析的建議準則。然而，文章也提到前載SFR測試的良好可靠性與不同的節點數據之間的一些差異，並強調了在使用前載SFR進行測試時，可能需要更多的基準測試來區分重複和非重複的節點缺陷。作者認為，前載SFR測試可能有助於確定視野缺陷的一致性，並且在進行測試時不會出現性能下降的情況。

English Abstract

The study investigated the feasibility of frontloading SITA-Faster (SFR) visual field tests by performing two tests per eye on the same visit in glaucoma clinics. The frontloading SFR tests provided repeatable data for evaluating consistency of pattern deviation defects in glaucoma, with no decline in performance from test fatigue, and at an equivalent duration and reliability as a single test. The study suggested that frontloading SFR may help increase testing frequency to meet recommended progression analysis guidelines. The analysis also highlighted the importance of addressing inherent fluctuations in threshold estimates between visual field (VF) tests and the potential for increasing the amount and quality of available perimetric data for interpretation within the resource constraints of eye clinics. The study found that the frontloaded SFR tests provided repeatable data that reversed a defect found in standard automated perimetry in some locations and identified new repeatable defects in others. This suggests that frontloading SFR tests can be used to distinguish between repeatable and nonrepeatable defects in glaucoma.

Ophthalmic Technology Assessment: Levodopa/Carbidopa to Augment the Treatment of Amblyopia

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眼科技術評估：使用左旋多巴/卡比多巴增強弱視治療

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

本研究旨在評估利用左旋多巴/卡比多巴(levodopa/carbidopa)增強弱視療法的臨床效力、有效性和安全性。研究人員通過在PubMed數據庫中進行文獻檢索，最後於2022年10月進行了英語文獻檢索，共檢索到55篇文章，其中有23篇全文被詳細審閱。最終確定了12篇文獻作為評估的適當範圍，並由專家組成小組對其進行了證據等級評級。研究結果顯示，因擔憂長期不良反應（如遲發性運動失調tardive dyskinesia），治療持續時間限制在3至16周。左旋多巴的劑量範圍為每天1.5至8.3mg/kg，通常分為3次每日的劑量。藥物的短期副作用通常報告不一致，但大多數是輕微的，包括頭痛和噁心。最終得出結論，目前最佳證據不足以顯示使用長達16周的左旋多巴/卡比多巴增強弱視療法將導致視力敏銳度的意義性改善。鑑於長期治療帶來的遲發性運動失調等嚴重副作用的潛在風險，左旋多巴/卡比多巴似乎不是弱視療法的可行選擇。未來研究可能專注於改變這些藥物的劑量、研究新的劑型，以增加多巴脂或其他神經傳遞物質功能，並減少副作用。

English Abstract

This article summarizes a review of studies on the use of levodopa/carbidopa to augment amblyopia therapy. The literature search yielded 55 articles, but only 12 were considered appropriate for inclusion. The duration of treatment with levodopa was limited to 3 to 16 weeks due to concerns about long-term adverse effects such as tardive dyskinesia, which were not reported in any of the study participants. The dose of levodopa ranged from 1.5 to 8.3 mg/kg/day, usually divided into 3 daily doses. The carbidopa dose was approximately 25% of the levodopa dose in all treatments. Short-term side effects were generally mild, including headache and nausea. However, the evidence is currently insufficient to show that augmenting amblyopia therapy with levodopa will result in meaningful improvement in visual acuity. The article suggests that pharmacologic augmentation of standard occlusive therapy for amblyopia has not been demonstrated to be effective with current treatment options, and future research may focus on changing medication dosages and studying newer agents to increase neurotransmitter functions and minimize side effects.

Prognostication in Stargardt Disease Using Fundus Autofluorescence: Improving Patient Care

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利用眼底自發螢光進行Stargardt病的預後評估：改善患者護理

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

本文描述了一項針對Stargardt病的後瞳自體螢光作用 (fundus autofluorescence, FAF)的預測研究。研究通過回顧性病例系列對Moorfields眼科醫院掛號的STGD患者進行分析，結果顯示居於不同年齡段的患者在眼底自體螢光成像（FAF）和電生理檢測(ERG)結果上存在明顯的差異。研究還提出了一種將FAF成像用於預測疾病發展情況的方法，並強調了兒童病例的特殊性。總的來說，該研究為Stargardt病的診斷和治療提供了重要的臨床資料，並對患者的後續管理提出了明確的建議。

English Abstract

This study aimed to assess the use of fundus autofluorescence (FAF) imaging as a prognostic tool for Stargardt disease (STGD) in comparison to electroretinography. The retrospective case series involved 234 patients meeting specific inclusion criteria. The results indicated that FAF imaging is effective in determining the extent of retinal involvement and can be used to inform prognostication. The study found a discrepancy between FAF and electroretinography in children with early-onset disease, suggesting that functional impairment detectable by electroretinography may precede structural loss detectable by FAF in this age group. Additionally, patients with milder FAF severity than electroretinography were significantly younger at the time of assessment and showed earlier age at onset. The study concluded that careful counseling and, ideally, electroretinography should be considered for the most accurate prognosis, especially in young patients with certain genetic variants and poor initial visual acuity. These findings have implications for patient care and decision-making in the management of STGD.

Ophthalmic Technology Assessment: Use of Mitomycin C in Dacryocystorhinostomy

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眼科技術評估：在淚囊鼻腔吻合術中使用丝裂霉素C

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

本研究評估mitomycin C（MMC）對於成人原發性獲得性鼻淚管阻塞（primary acquired nasolacrimal duct obstruction）的外科手術結果的影響。該研究使用包括external, endoscopic endonasal, or diode laser-assisted transcanalicular DCR等手術方式，並討論了醫用MMC對於手術結果的影響。結果顯示，MMC使用能使鼻咽喉出血風險降低，可減少顆粒組織(granulation tissue)生成和術后鼻部清除(nasal devridements)的次數。然而，這不一定能轉化為功能性的成功。雖然一些研究指出MMC有助於改善手術成功率，但也有相反的研究顯示MMC對於手術結果並無統計學上的改善。因此，MMC在手術操作中是否能有效提高功能與解剖手術結果，仍需進一步深入研究。

English Abstract

The content discusses the use of Mitomycin C (MMC) in various types of dacryocystorhinostomy (DCR) surgeries for primary acquired nasolacrimal duct obstruction (NLDO). The inclusion criteria required controlled studies on the effect of MMC on outcomes of external, endoscopic endonasal, or diode laser-assisted transcanalicular DCR in adults with a minimum 6-month follow-up and at least 10 participants. The use of MMC did not improve outcomes statistically in diode laser-assisted transcanalicular DCR studies. However, MMC use did result in a larger ostium size, decreased granulation tissue formation, and a decreased number of postoperative nasal debridements compared with controls but this did not translate into improved functional success.

Patient-Reported Outcome Measure Use in Guidelines Published by the American Academy of Ophthalmology

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美國眼科學會發布的指南中患者報告結果測量的使用

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

這篇文章以”發表於美國眼科學院 (AAO)的指引中使用患者報告結果量表(Patient-Reported Outcome Measures (PROMs) 為題，回顧了患者報告結果量表的使用情況。而PROMs是一種標準化工具，可提供患者健康狀況或與健康相關的生活品質資訊。文章發現，儘管基礎研究提供了患者基於證據的照顧基礎，並回答了特定研究問題，但這些參數本身無法充分捕捉患者的感受。因此，為促進更好的照顧品質和健康結果，建議在管理建議中合適時應納入PROMs。

此外，共識性陳述，基於最佳可得證據、臨床專業知識和患者經驗形成的臨床實踐指引 (Clinical Practice Guidelines) 在臨床中具有重要作用，且在探討眼科疾病治療的2458份研究中，未能發現PROMs 的廣泛應用。對此提出了需要改善眼科診療中PROMs 的運用，以協助患者在臨床中共享決策。

總的來說，意見建議需要進一步加強PROMs 在眼科領域的驗證與質量評估，並提供了解釋臨界顯著差異的方法，並呼籲臨床照顧與最終目標——患者認為最有益與有影響的照顧相結合。

English Abstract

This review discusses the use of Patient-Reported Outcome Measures (PROMs) in clinical practice guidelines published by the American Academy of Ophthalmology. It stresses the importance of incorporating PROMs into management recommendations due to their ability to capture a patient’s experience with a given condition. The study reveals that PROMs are not consistently considered in ophthalmology guidelines, highlighting the need for their active incorporation into clinical trials and research. The review also emphasizes the importance of assessing the quality and validation of PROMs in ophthalmology. Additionally, it advocates for the use of Minimal Important Differences (MIDs) to interpret PROM results effectively. The study concludes by underlining the need to bridge the gap between research and clinical practice, with a focus on enhancing patient-centered outcomes in ophthalmology.

Long-term Outcomes in Patients Undergoing Surgery for Primary Congenital Glaucoma between 1991 and 2000

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1991年至2000年間接受原發性先天性青光眼手術患者的長期結果

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

這篇文章討論了早產性青光眼 primary congenital glaucoma (PCG) 患者長期手術和視覺結果的估算。兩百二十個眼睛(一百二十一名患者)於1991年1月至2023年10月接受了原發性結膜穿刺腔輸入結膜混合手術 combined trabeculotomy-trabeculectomy (CTT)而無使用mitomycin C。Kaplan-Meier存活分析用於估算手術和功能成功的機率。在單變量分析中，任何額外的非青光眼眼內手術導致手術失敗風險較高。在多變量分析中，未發現任何臨床參數與失敗有顯著相關。在接受原發性CTT的眼睛中，28只（14.4%）需要第二次手術來控制眼壓。研究顯示CTT是一個有效的程序，對控制眼壓和中等視覺康復具有持久性效果，持續20年以上。

English Abstract

The purpose of the study was to evaluate the long-term surgical and visual outcomes in patients with primary congenital glaucoma (PCG) who underwent surgery, specifically the combined trabeculotomy-trabeculectomy (CTT) procedure. The study assessed the success rates and risk factors for surgical failure and poor visual outcomes. The researchers examined the records of 220 eyes of 121 patients who underwent surgery for PCG between January 1991 and 2011. Kaplane Meier survival analysisr evealed 1-year,10-year,and 20-year complete success rates of 90.7%,78.9%, and 44.5%, respectively. Overall,the proportion of eyes with good,fair, and poor visual outcomes was 33.2%, 16.4%, and 50.4%, respectively.The study found that CTT is a useful procedure for long-term intraocular pressure (IOP) control and moderate visual recovery in PCG patients over a 20-year follow-up period after surgery. The findings suggest that CTT without mitomycin C can be considered as the initial glaucoma procedure in children with PCG, as it can achieve good long-term surgical success and provide moderate visual outcomes. The study also highlighted the importance of long-term follow-up and the challenges of treating PCG, as patients often require multiple procedures for IOP control.

Prevalence and Associations of Nonglaucomatous Optic Nerve Atrophy in High Myopia

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高度近視中非青光眼性視神經萎縮的盛行率與相關性

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

本研究旨在評估高度近視患者中非青光眼性視神經萎縮（nonglaucomatous optic nerve atrophy (NGOA)的盛行率。研究納入俄羅斯烏拉爾眼科醫學調查中的5899名患者( 80.5% of 7328名適格個體)進行了評估。NGOA被分為5個任意階段(arbitrary stages)，其特徵包括網膜神經纖維層（retinal nerve fiber layer, RNFL）照片上的視線減弱(decreased visibility)、神經視網膜緣蒼白(neuroretinal rim pallo)r、網膜動脈直徑異常變薄(abnormally thin retinal arteriole diameter)以及由光學相干斷層掃描儀測定的網後神經維系膜異常變薄(abnormally thin peripapillary RNFL as measured by OCT)。研究中顯示高度近視患者中NGOA的盛行率為29.3％，具有NGOA的眼睛的平均程度為1.7個任意單位。此外，在研究中還觀察到，高度深度的近視可能與視野損失和中心視力下降有關，但這不能單純通過近視黃斑病變來解釋。因此，這項研究提供了有關高度近視及NGOA盛行率及其影響因素之相關信息。

English Abstract

This study aimed to determine the prevalence and factors associated with nonglaucomatous optic nerve atrophy (NGOA) in highly myopic individuals. Out of 116 highly myopic participants, 34 individuals (29.3%) were identified to have NGOA. The degree of NGOA was found to increase with longer axial length and wider temporal parapapillary gamma zone. The study highlighted the potential impact of NGOA on visual field and central visual acuity, particularly in highly myopic eyes. Additionally, the association between higher prevalence of NGOA and certain systemic parameters like systolic blood pressure was noted. While previous research has mainly focused on glaucomatous optic neuropathy, this study shed light on the prevalence and significance of NGOA in high myopia. Nonetheless, further follow-ups and investigations are needed to better understand the causes and potential therapeutic approaches for NGOA in highly myopic individuals.

Infections from Over-the-Counter Artificial Tears: Implications for Patients and Clinicians

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非處方人工淚液引起的感染：對患者和臨床醫生的影響

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

Ophthalmology Volume 130, Number 11, November 2023

中文摘要

這篇文章討論了近期美國發生的非處方潤眼液(over-the-counter artificial tears)引發感染事件對於病患和臨床醫師的影響。文章指出，在2023年2月2日的美國晚間新聞節目中報導了一種懷疑受污染的非處方潤眼液引發感染的事件。該事件起源於2022年5月洛杉磯出現兩宗眼部感染案例，而在2022年11月的流行病學調查中，發現了一種可疑的共同產品。隨後，美國食品和藥物管理局（FDA）和疾病控制與預防中心發出警告，並對生產商進行調查，指出其違反了良好製造規範。此外，作者還提出了病患應該注意的對策，以及對非處方潤眼液的管制和品質進行了深入討論。文章指出，美國需要提高對眼科製藥產品品質的認識，並呼籲臨床醫師密切關注藥品的化學、製造和控制。

English Abstract

The content discusses the implications of infections caused by contamination in over-the-counter artificial tears. A national alert was raised in the United States after reports of infections linked to a specific over-the-counter lubricant eye drop product. The FDA and CDC issued warnings about the product distributed by Delsam Pharma, leading to concerns about the quality and safety of all topical ophthalmic medications. The article highlights the need to increase awareness about the quality of ophthalmic pharmaceutical products, as well as the risks associated with compounded products from pharmacies. The author provides guidance for patients and recommends vigilance for signs of infection and discontinuation of recalled products. The content emphasizes the importance of ensuring the sterility and quality of ophthalmic medications to prevent potential public health crises.This content covers updates and safety communications from the United States Food and Drug Administration (FDA) regarding various medical devices and medications.

Risk of New Retinal Vascular Occlusion After mRNA COVID-19 Vaccination Within Aggregated Electronic Health Record Data

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使用聚合電子健康記錄數據分析mRNA COVID-19疫苗接種後新視網膜血管閉塞的風險

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

JAMA Ophthalmology May 2023 Volume 141, Number 5]

中文摘要

近期文獻已經描述了在mRNA COVID-19疫苗接種後發生新發性視網膜血管阻塞(retinal vascular occlusion, RVO)的情況。因為RVO可能導致視力喪失或失明，對這種潛在關聯進行流行病學調查對公共衛生非常重要。本研究使用TriNetX Analytics平台的回顧性基於人口的總體研究設計，該平台是一個匯總的電子健康記錄(EHR)研究網絡，包含超過1.03億名患者的去識別EHR數據，用於檢查匯總EHR數據。研究結果表明，接種mRNA COVID-19疫苗後新發性RVO的診斷非常罕見，與流感和白喉百日咳 (Tdap) 疫苗的發生率相似。未找到支持mRNA COVID-19疫苗與新診斷的RVO之間存在關聯的證據。這項研究的結果表明，相對於過去常用的流感和Tdap疫苗，接種mRNA COVID-19疫苗對於可能導致視力威脅的這種潛在不良事件的診斷率非常低。

English Abstract

A retrospective cohort study using aggregated electronic health record (EHR) data was conducted to investigate the risk of new-onset retinal vascular occlusion (RVO) following mRNA COVID-19 vaccination. The study compared the occurrence of RVO after COVID-19 vaccination with that after influenza and tetanus, diphtheria, pertussis (Tdap) vaccinations. Of 3108829 patients (mean[SD] age at vaccination, 50.7[20.4]years; 56.4% women) who received the mRNA COVID-19 vaccine,104 (0.003%;95%CI, 0.003%-0.004%) patients had a new diagnosis of RVO within 21 days of vaccinationThe findings suggest that RVO diagnosed acutely after mRNA COVID-19 vaccination is extremely rare and occurs at similar rates to those of influenza and Tdap vaccines. No evidence of an association between mRNA COVID-19 vaccination and newly diagnosed RVO was found. The study highlights the low rates of this potential adverse event and contributes to the overall safety profile of mRNA COVID-19 vaccines.