6月 | “ RIO”论文推荐

卫视博每月从三大权威杂志:Retina、Investigative Ophthalmology & Visual Science、Ophthalmology中各推荐一篇眼科论文。— — 最佳“RIO”论文推荐(6月)

No.1
Retina · 推荐
INCIDENCE AND RISK FACTORS OF POSTOPERATIVE ENDOPHTHALMITIS AFTER PRIMARY SURGICAL REPAIR COMBINED WITH INTRAOCULAR FOREIGN BODY REMOVAL(Retina: June 2022 – Volume 42 – Issue 6 – p 1144-1150)

眼内异物清除术后眼内炎发生率及危险因素分析
Purpose
To analyze the incidence and risk factors of postoperative endophthalmitis  after primary surgical repair and intraocular foreign body (IOFB) removal within 24 hours of injury.分析损伤后24小时内一次手术修复和眼内异物(IOFB)切除术后眼内炎的发生率和危险因素。

Methods
The records of all patients treated surgically for open globe injury and IOFBremoval at the Eye Hospital of Shandong First Medical University between January 1, 2015, and June 30, 2020, were retrospectively reviewed. Variables included time from injury to operation, cause of injury, details of surgical repair, and follow-up. The incidence and risk factors of endophthalmitis after IOFB removal were studied.回顾性审查了2015年1月1日至2020年6月30日在山东第一医科大学眼科医院接受开放性眼球损伤和IOFB切除手术治疗的所有患者的记录。变量包括从受伤到手术的时间,受伤原因,手术修复的细节和随访。研究了IOFB切除术后眼内炎的发生率和危险因素。

Results
During 5 years, 99 patients with IOFB were reviewed. Of these, 19 patients were diagnosed with endophthalmitis on admission, and 5 were suspected of having endophthalmitis during operation. Fifty-four cases had no clinical signs of endophthalmitis on admission and during operation and were treated with operation within 24 hours after the injury. Two patients (2 of 54; 3.70%) developed endophthalmitis after IOFB removal, and the causative agent in both cases was Bacillus cereus.在5年中,对99例IOFB患者进行了评价。其中,19例患者入院时被诊断为眼内炎,5例患者在手术时被怀疑患有眼内炎。54例入院和手术时无眼内炎临床体征,伤后24小时内接受手术治疗。2 例患者(54 例中的 2 例;3.70%)在 IOFB 切除后出现眼内炎,两例的致病因子均为蜡样芽孢杆菌。

Conclusion
 The incidence of infectious endophthalmitis after primary surgical repaircombined with IOFB removal (#24 hours) was 3.70% in patients who received a series of standard treatments, and B. cereus infection might be a risk factor.在接受一系列标准治疗的患者中,一次手术修复联合IOFB切除(#24小时)后感染性眼内炎的发病率为3.70%,而蜡样芽孢杆菌感染可能是一个危险因素。

本研究探索了眼内异物清除术后眼内炎发生率及危险因素,原发性眼内修复术后感染性眼内炎的发生率联合IOFB摘除(#24小时)在接受一系列标准治疗的患者中占3.70%,蜡样芽胞杆菌感染可能是一个危险因素。文章创新点是对患者进行一个回顾性的研究,观察患者术后发生眼内炎的可能性及感染的菌株,有对患者的追溯观察。

文章的不足之处为在随访的过程中患者的信息收集可能会有误差,患者的每个人都有差异,对结果可能有一定的影响。有少量的患者在切除IOFB后发生感染性眼内炎。并且没有进行数据的统计分析,需要进一步的研究来阐明风险因素。

No.2
Investigative Ophthalmology & Visual Science · 推荐

High-Density Optical Coherence Tomography Analysis Provides Insights Into Early/Intermediate Age-Related Macular Degeneration Retinal Layer Changes(May 2022, Vol.63, 36. doi:https://doi.org/10.1167/iovs.63.5.36 )

高密度光学相干断层扫描分析提供对早期/中期年龄相关性黄斑变性视网膜层变化的见解
Purpose
To topographically map all of the thickness differences in individual retinal layers between early/intermediate age-related macular degeneration (AMDearly/AMDint) and normal eyes and to determine interlayer relationships.1从地形上映射早期/中期年龄相关性黄斑变性(AMDearly/AMDint)和正常眼睛之间单个视网膜层的所有厚度差异,并确定层间关系。

Methods
Ninety-six AMDtotal (48 AMDearly and 48 AMDint) and 96 normal eyes from 192 participants were propensity-score matched by age, sex, and refraction. Retrospecive optical coherence tomography (OCT) macular cube scans were acquired, and highdensity (60 × 60 0.01-mm2) grid thicknesses were custom extracted for comparison between AMDtotal and normal eyes corrected for confounding. Resultant “normal differences” underwent cluster, interlayer correlation, and dose–response analyses for the retinal nerve fiber layer (RNFL), ganglion cell layer (GCL), inner plexiform layer (IPL), inner nuclear layer (INL), outer plexiform layer (OPL), outer nuclear layer + Henle’s fiber layer (ONL+HFL), inner and outer segment (IS/OS) thickness, and retinal pigment epithelium (RPE) to Bruch’s membrane (BM) thickness.来自192名参与者的96只AMDtotal(48 AMDearly和48 AMDint)和96只正常眼睛的倾向评分与年龄,性别和屈光相匹配。获取逆向光学相干断层扫描(OCT)黄斑立方体扫描,并定制提取高密度(60×60 0.01-mm2)网格厚度,以比较AMDtotal和正常眼睛之间的混淆。对视网膜神经纤维层(RNFL)、神经节细胞层(GCL)、内丛状层(IPL)、内核层(INL)、外丛状层(OPL)、外核层+Henle纤维层(ONL+HFL)、内和外段(IS/OS)厚度以及视网膜色素上皮(RPE)至布鲁氏膜(BM)厚度进行了簇状、层间相关性和剂量-反应分析。

Results
AMDtotal inner retinal clusters demonstrated extensively thinned RNFL, GCL, IPL,and paracentral INL and thickened INL elsewhere, with normal difference means ranging from −8.13 μm (95% confidence interval [CI], −11.12 to −5.13) to 1.58 μm (95% CI, 1.07–2.09) (P < 0.0001 to P < 0.05). Outer retinal clusters displayed thinned paracentral OPL/ONL+HFL, central IS/OS, and peripheral RPE–BM and thickened central RPE–BM, with means ranging from −1.31 μm (95% CI, −2.06 to −0.55) to 2.99 μm (95% CI, 0.97– 5.01] (P < 0.0001 to P <0.05). Effect sizes (−2.56 to 9.93 SD), cluster sizes, and eccentricity effects varied. All interlayer correlations were negligible to moderate regardless of AMD severity. Only the RPE–BM was partly thicker with greater AMD severity (up to 5.44 μm; 95% CI, 4.88–6.00; P < 0.01).AMDtotal内部视网膜簇显示RNFL,GCL,IPL,广泛变薄,其他部位 INL 增厚,正差均值范围从−8.13 μm(95%置信区间[CI],−11.12到−5.13)到1.58μm(95%CI,1.07-2.09)(P<0.0001到P<0.05)。视网膜外簇显示中心旁OPL/ONL+HFL、中心IS/OS和外周RPE-BM以及中心RPE-BM增厚,均值范围为−1.31 μm(95% CI,−2.06至−0.55)至2.99 μm(95% CI,0.97–5.01](P <0.0001至P <0.05)。效应大小(−2.56 至 9.93 SD)、簇大小和偏心率效应各不相同。无论AMD严重程度如何,所有层间相关性均可忽略不计至中等。只有RPE-BM部分较厚,AMD严重程度更高(高达5.44μm; 95%CI,4.88-6.00;P < 0.01)。

Conclusion
From the early stage, AMD eyes demonstrate thickness differences compared to normal with unique topographies across all retinal layers. Poor interlayer correlations highlight that the outer retina inadequately reflects complete retinal health. The clinical importance of OCT assessment across all individual retinal layers in early/intermediate AMD requires further investigation.从早期阶段开始,AMD的眼睛就表现出与正常人相比的厚度差异,在所有视网膜层上都有独特的地形。层间相关性差凸显了外视网膜不能充分反映完整的视网膜健康。在早期/中期AMD中,OCT评估在所有个体视网膜层中的临床重要性需要进一步研究。

本文为高密度光学相干断层扫描分析为早期/中期年龄相关性黄斑变性视网膜层改变提供了见解,96只早期/中期年龄相关性黄斑变性视网膜层眼和96只正常眼,一共192个参与者获得了逆向光学相关断层扫描(OCT)黄斑立方体扫描对视网膜神经纤维层(RNFL)、神经节细胞层(GCL)、内丛状层(IPL)、内核层(INL)、外丛状层(OPL)、外核层+ Henle s纤维层(ONL+HFL)、内外节段(IS/OS)厚度以及视网膜色素上皮(RPE)和Bruch s膜(BM)厚度进行了聚类分析、层间相关性和剂量反应分析。

文章创新之处在采用对比论证,设计详细,减少误差,得出较差的层间相关性强调外层视网膜不能充分反映完全的视网膜健康状况。

不足之处在于在早期/中期AMD中,OCT评估所有个体视网膜层的临床重要性需要进一步研究。目前还没有既定的准则界定每个单独的视网膜层的临床重要厚度差异,特别是在人工分割的情况下的重要厚度差异。

No.3
Ophthalmology · 推荐
Genotypic and Phenotypic Spectrum of  Foveal Hypoplasia:A Multicenter Study(Volume 129, Issue 6, June 2022, Pages 708-718)

中央凹发育不全的基因型和表型谱:一项多中心研究
Purpose
To characterize the genotypic and phenotypic spectrum of foveal hypoplasia (FH).表征中央凹发育不全(FH)的基因型和表型谱。

Design
Multicenter, observational study.多中心观察研究

Participants
Individuals with a confifirmed molecular diagnosis and availability of foveal OCT scans were identifified from 12 centers or from the literature between January 2011 and March 2021. A genetic diagnosis was confifirmed by sequence analysis. Grading of FH was derived from OCT scans.在2011年1月至2021年3月期间,从12个中心或文献中识别出具有确认分子诊断和中央凹OCT扫描可用性的个体。通过序列分析证实了遗传诊断。FH的分级来自OCT扫描。

Methods
Individuals with a confifirmed molecular diagnosis and availability of foveal OCT scans were identifified from 12 centers or from the literature between January 2011 and March 2021. A genetic diagnosis was confifirmed by sequence analysis. Grading of FH was derived from OCT scans.在2011年1月至2021年3月期间,从12个中心或文献中识别出具有确认分子诊断和中央凹OCT扫描可用性的个体。通过序列分析证实了遗传诊断。FH的分级来自OCT扫描。

Main outcome measures
Grade of FH, presence or absence of photoreceptor specialization (PRS+vs PRS -), molecular diagnosis, and visual acuity (VA).晚期AMD被定义为在年度体检中在眼底照片或医疗记录中发现的区域萎缩或新生血管性年性黄斑变性,包括玻璃体内注射抗血管内皮生长因子药物。

Results
The most common genetic etiology for typical FH in our cohort was albinism (67.5%), followed by PAX6 (21.8%), SLC38A8 (6.8%), and FRMD7 (3.5%) variants. AHR variants were rare (0.4%). Atypical FH was seen in 67.4% of achromatopsia cases. Atypical FH in achromatopsia had signifificantly worse VA than typical FH (P < 0.0001). There was a signifificant difference in the spectrum of FH grades based on the molecular diagnosis (chi-square =60.4, P < 0.0001). All SLC38A8 cases were PRSe (P= 0.003), whereas all FRMD7 cases were PRS +(P < 0.0001). Analysis of albinism subtypes revealed a signifificant difference in the grade of FH (chisquare =31.4, P < 0.0001) and VA (P= 0.0003) between oculocutaneous albinism (OCA) compared with ocular albinism (OA) and HermanskyePudlak syndrome (HPS). Ocular albinism and HPS demonstrated higher grades of FH and worse VA than OCA. There was a signifificant difference (P < 0.0001) in VA between FRMD7 variants compared with other diagnoses associated with FH.在我们的队列中,典型FH最常见的遗传病因是白化病(67.5%),其次是PAX6(21.8%),SLC38A8(6.8%)和FRMD7(3.5%)变异。AHR变异体很少见(0.4%)。非典型FH见于67.4%的色盲病例。消色盲症中的非典型FH比典型FH明显更差(P <0.0001)。基于分子诊断,FH等级谱存在显著差异(卡方=60.4,P<0.0001)。所有SLC38A8病例均为PRSe(P= 0.003),而所有FRMD7病例均为PRS +(P <0.0001)。对白化病亚型的分析显示,与眼部白化病(OA)和HermanskyePudlak综合征(HPS)相比,眼部皮肤白化病(OCA)在FH(chisquare = 31.4,P <0.0001)和VA(P = 0.0003)的等级差异很大。眼白化病和HPS表现出比OCA更高的FH等级和更差的VA。与其他与FH相关的诊断相比,FRMD7变体之间的VA差异显着(P <0.0001)。

Main outcome measures
We characterized the phenotypic and genotypic spectrum of FH. Atypical FH is associated with a worse prognosis than all other forms of FH. In typical FH, our data suggest that arrested retinal development occurs earlier in SLC38A8, OA, HPS, and AHR variants and later in FRMD7 variants. The defined time period of foveal developmental arrest for OCA and PAX6 variants seems to demonstrate more variability. Our findings provide mechanistic insight into disorders associated with FH and have significant prognostic and diagnostic value.我们表征了FH的表型和基因型谱。与所有其他形式的 FH 相比,非典型 FH 的预后更差。在典型的FH中,我们的数据表明,在SLC38A8,OA,HPS和AHR变体中更早发生视网膜发育停滞,后来在FRMD7变体中发生。OCA和PAX6变体的中央凹发育停滞的确定时间段似乎显示出更多的变异性。我们的研究结果为与FH相关的疾病提供了机械洞察力,并具有显着的预后和诊断价值。

推荐理由
本研究探索了中央凹发育不全的基因型和表型谱,OCA和PAX6变异对中央凹发育停止的定义时间似乎显示出更多的可变性文章创新点是多中心观察研究,观察范围广,收集资料全,观察变量多,发现在典型的FH中,数据表明,视网膜发育受阻在SLC38A8、OA、HPS和AHR变异中发生得更早,在FRMD7变异中发生得更晚

文章的不足之处为数据相对可能要注意纳入标准要更详细一点,在PAX6中可能存在泛视的情况,眼球震颤在不同的病例中也是可变的,这也可能导致VA的降低,可能有一些选择偏差,包括了由OCT确定的患有FH的患者,有可能排除了有介质不透明的患者。

喜报!广州卫视博再次荣获广东省年度质量信用A类医疗器械生产企业称号

5月27日,以“诚就高质量,粤向新时代”为主题,广东省2021年度质量信用A类医疗器械生产企业发布会在江门市顺利召开。会上公布了2021年度质量信用A类医疗器械生产企业名单,广州卫视博生物科技有限公司已是第二次获评!
 

A类质量信用企业

据悉,广东省医疗器械生产企业质量信用分类监管于2011年实施,依据法规对生产企业质量管理行为进行综合评价,结合企业行业纪录,确定质量信用类别,医疗器械生产企业质量信用类别分为A、B、C三个类别。
A类质量信用企业指质量管理良好企业,且具备六项条件,其中包括无违反医疗器械监督管理有关法律、法规、规章以及各级药监部门发布的医疗器械监督管理的其他规定的行为,无违反相关规定的不良行为等等,审核标准相当严格。B类质量信用企业指质量管理合格企业;C类质量信用企业指质量管理缺陷企业。
根据《广东省医疗器械生产企业质量信用分类监管工作的意见》,A类质量信用企业指质量管理良好企业,应该具备以下条件:
1、无违反医疗器械监督管理有关法律、法规、规章以及各级药监部门发布的医疗器械监督管理的其他规定的行为;无违反本规定的不良行为;2、企业管理者代表较好地履行各项职责,企业医疗器械质量管理体系能够有效运行;3、近二年产品上市监督抽样检测结论合格;

4、日常监督检查重点项目全部符合要求,一般项目不合格项小于10%;各项质量管理综合评价均为良好;

5、积极参加法规、专业培训;主动收集和保存法规、技术标准;

6、企业管理者代表通过广东省食品药品监管系统网上办事平台按时填报企业质量管理体系运行信息和产品年度质量回顾分析报告等相关信息。

广州卫视博拥有万级洁净厂房近2000平方米,获得III类医疗器械生产许可证和销售许可证。公司主要研发、生产和销售眼科高端医疗产品,具有丰富的产品链,代表产品折叠式人工玻璃体(FCVB)、折叠顶压球囊(FCB)和高度近视后巩膜加固系统。其中FCVB是国际首创的挽救眼球的人工器官,可以精细模拟人眼玻璃体结构和功能。该产品入选国家科技部2018年医疗器械创新产品目录,被国家药监局在改革开放40周年回顾中,列为“中国制造”向“中国创造”的一个典型范例。FCB是微创治疗孔源性视网膜脱离的创新产品,于2019年7月启动临床研究,共21家眼科医院参与了该项目的临床研究,该产品的上市,将为广大孔源性视网膜脱离患者带来新的希望。高度近视后巩膜加固系统由卫视博自主研发,用于延缓近视加剧,治疗高度近视引起的后巩膜葡萄肿、视网膜劈裂等,目前已获得北京同仁医院伦理审查批件,正在多家医院进行临床试验。
在2019年,卫视博就曾获得当年年度质量信用A类医疗器械企业。此次再次获评,体现了行业监管部门对卫视博在质量管理、信用体系方面的高度肯定与认可,这来源于卫视博对国家相关政策和法律法规的贯彻落实,以及对质量管理的严格把控和不断追求。未来,卫视博将继续坚持“将医生的智慧换成成产品,点亮患者生活,建立世界一流高端眼科创新性平台公司”的发展使命,不断优化改进质量管理体系,精益求精,持续为患者带来更好的产品和服务体验。

2022年3月份RIO论文推荐

SILICONE OIL–FILLED FOLDABLE CAPSULAR VITREOUS BODY VERSUS SILICONE OIL ENDOTAMPONADE FOR TREATMENT OF NO LIGHT PERCEPTION AFTER SEVERE OCULAR TRAUMA

(Retina: March 2022 – Volume 42 – Issue 3 – p 553-560)

硅油填充的折叠式人工玻璃体球囊和硅油填充治疗严重眼外伤后的无光感眼

Purpose

To compare the anatomical and functional outcomes of silicone oil (SO)–fifilled foldable capsular vitreous body (FCVB) and SO endotamponade in vitrectomy for patients with no light perception after ocular trauma.

比较硅油填充的折叠式人工玻璃体球囊(FCVB)和硅油(SO)填充在严重眼外伤无光感眼患者玻璃体切割术术后的解剖和功能结果。

Methods

A total of 64 patients (64 eyes) with no light perception caused by severe ocular trauma were divided into FCVB and SO groups based on the surgical treatment. The main outcome measurements were retinal reattachment rate, intraocular pressure, bestcorrected visual acuity, and number of operations.

将64例(64只眼)严重眼外伤致无光感患者根据手术治疗情况分为FCVB组和SO组。主要观察指标为视网膜再附着率、眼压、最佳矫正视力和手术次数。

Results

Both the FCVB group (29 eyes) and the SO group (35 eyes) showed signifificant improvement in postoperative best-corrected visual acuity and intraocular pressure. The two groups showed no signifificant differences in fifinal intraocular pressure and the retinal reattachment rate. The postoperative vision ($LP) in the FCVB group was signifificantly worse than in the SO group (FCVB [4/29] vs. SO [18/35], P = 0.003). However, the number of surgeries in the FCVB group was signifificantly lower than in the SO group (FCVB [1.10] vs. SO [2.23], P , 0.001).

FCVB组(29眼)和SO组(35眼)术后最佳矫正视力和眼压均有明显改善。两组末次随访眼压及视网膜再附着率无显著差异。FCVB组术后视力($LP)明显低于SO组(FCVB [4/29] vs. SO [18/35], P = 0.003)。但FCVB组的手术次数明显低于SO组(FCVB [1.10] vs. SO [2.23], P, 0.001)。

Conclusion

 Vitrectomy combined with SO endotamponade shows better short-term improvement in the treatment of no light perception caused by severe ocular trauma. However, SO-fifilled FCVB can effectively prevent many complications caused by direct SO endotamponade, such as secondary surgeries or SO dependence.

玻璃体切割术联合SO内填充治疗重度眼外伤无光感短期疗效较好。然而,硅油填充的FCVB能有效预防SO直接填充引起的许多并发症,如二次手术或硅油依赖眼等。

本文研究了硅油填充的FCVB与硅油填充治疗严重眼外伤后无光感对比分析了两种手术的优点和缺点,FCVB有助于减少术后并发症的发生,但玻璃体切除术联合SO内填充治疗重度眼外伤无光感短期疗效较好。

本文创新之处在于通过科学的对比,分析了无光感眼接受两种手术方式后患者的术后并发症和视力比较,得出FCVB手术可以有效预防患者术后并发症,预后好;在视力方面,SO直接填充只能起到短期的一个维持效果,从长远角度来看,预后并发症多,二次手术可能性大。

文章不足之处在于未对SO二次手术效果与第一次做FCVB手术效果进行进一步分析,SO直接填充的二次手术是否优于第一次,效果是否优于首次FCVB手术。

No.2

Investigative Ophthalmology & Visual Science · 推荐

Study of the Correlation Between Severity of Endophthalmitis and Posterior Vitreous Detachment Using a Rabbit Endophthalmitis Model

( Investigative Ophthalmology & Visual Science February 2022, Vol.63, 6. )

用兔眼内炎模型研究眼内炎严重程度与玻璃体后脱离的相关性

Purpose

We have reported that the absence of posterior vitreous detachment (PVD) is related to the onset and severity of infectious endophthalmitis, based on clinical experience. To demonstrate clinical findings in animal models, we created endophthalmitis models for the presence or absence of PVD and examined differences in severity.

我们根据临床经验报道,后玻璃体脱离(PVD)的缺失与感染性眼内炎的发病和严重程度有关。为了证明动物模型的临床结果,我们创建了有或没有眼内病变的眼内炎模型,并检查了严重程度的差异。

Methods

We estimated a rabbit infectious eye model with and without PVD using Pseudomonas aeruginosa (PVD(+) and PVD(−) groups). After injection of bacteria inoculation for 3, 6, 12, and 24 hours, we evaluated the clinical score of the anterior chamber (n = 14). Removing the vitreous and retina from the enucleated eyeballs, the number of bacteria was counted using each specimen (n = 12). In addition, the number of inflammatory cells approximately 3 mm2 around the optic disc and histopathologic grading of intraocular inflammation was compared from histopathologic images (n = 7). Elec-troretinogram (ERG) was performed in experimentally infected rabbit eyes in both groups at three times after injection of the bacterial suspension.

我们用铜绿假单胞菌(PVD(+)组和PVD(-)组)对兔传染性眼模型进行评估。在接种细菌3、6、12和24小时后,我们对14例患者的前房进行临床评分。摘除眼球的玻璃体和视网膜后,每个标本计数细菌数(n = 12)。此外,炎症细胞的数量约3平方毫米在视神经盘和组织病理分级的眼内炎症比较病理图像(n = 7)。Elec-troretinogram (ERG)进行实验感染兔的眼睛在两组细菌悬液注射后的三倍。

Results

There was no difference between the two groups in the clinical score of the anterior chamber of each time phase, but the bacterial cultures showed significantly fewer bacteria in the PVD(−) group 24 hours after bacterial inoculation (P < 0.05). Furthermore, the number of inflammatory cells was significantly less in the PVD group (P < 0.05). As a result of ERG, the decreases of a- and b-waves in amplitude were significantly greater in the PVD(−) group than in the PVD(+) group.

两组前房各时间阶段的临床评分差异无统计学意义,但PVD(-)组在细菌接种24小时后细菌培养量明显减少(P <0.05)。此外,PVD组炎症细胞数量显著减少(P <0.05)。ERG结果显示,PVD(-)组a波和b波振幅的下降明显大于PVD(+)组。

Conclusion

The present study confirms using animal models that the absence of PVD contributed to the severity of bacterial endophthalmitis.

本研究通过动物模型证实,PVD的缺失与细菌性眼内炎的严重程度有关。

本文通过动物实验研究了眼内炎严重程度与玻璃体后脱离的相关性,得出PVD的缺失与细菌性眼内炎的严重程度有关。

文章创新之处在利用动物做实验,观察更加直接,结果准确,将兔眼内严重程度做了对比分析,直接清晰可靠,数据清楚明了,有利于分析。

本文的不足之处在于未将兔眼内炎和人眼内炎做一个比较分析,有利于结果的准确性未考虑到潜在变化,未来可进一步继续优化设计方案的科学性。

No.3

Ophthalmology · 推荐

Effificacy and Safety of 8 Atropine Concentrations for Myopia Control in Children

(Volume 129, Issue 3, March 2022, Pages 322- 333)

8种阿托品浓度控制儿童近视的疗效和安全性

Topic

Comparative effificacy and safety of different concentrations of atropine for myopia control.

不同浓度阿托品控制近视的疗效和安全性比较。

Clinical Relevance

Atropine is known to be an effective intervention to delay myopia progression. Nonetheless, no well-supported evidence exists yet to rank the clinical outcomes of various concentrations of atropine.

阿托品被认为是延缓近视进展的有效干预手段。尽管如此,目前还没有得到充分支持的证据对不同浓度阿托品的临床结果进行排序。

Methods

We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov on April 14, 2021. We selected studies involving atropine treatment of at least 1 year’s duration for myopia control in children. We performed a network meta-analysis (NMA) of randomized controlled trials (RCTs) and compared 8 atropine concentrations (1% to 0.01%). We ranked the atropine concentrations for the corresponding outcomes by P score (estimate of probability of being best treatment). Our primary outcomes were mean annual changes in refraction (diopters/ year) and axial length (AXL; millimeters/year). We extracted data on the proportion of eyes showing myopia progression and safety outcomes (photopic and mesopic pupil diameter, accommodation amplitude, and distance and near best-corrected visual acuity [BCVA]).

我们于2021年4月14日搜索了PubMed、EMBASE、Cochrane对照试验中央注册、世界卫生组织国际临床试验注册平台和ClinicalTrials.gov。我们选择了阿托品治疗至少1年的儿童近视控制的研究。我们对随机对照试验(rct)进行了网络荟萃分析(NMA),并比较了8个阿托品浓度(1%至0.01%)。我们根据P评分(对最佳治疗可能性的估计)对相应结果的阿托品浓度进行排序。我们的主要结果是每年的平均屈光度(屈光度/年)和轴长(AXL;毫米/年)。我们提取了显示近视进展和安全结果(光和介浅瞳孔直径、调节幅度、距离和近最佳矫正视力[BCVA])的眼睛比例的数据。

Results

Thirty pairwise comparisons from 16 RCTs (3272 participants) were obtained. Our NMA ranked the 1%, 0.5%, and 0.05% atropine concentrations as the 3 most benefificial for myopia control, as assessed for both primary outcomes: 1% atropine (mean differences compared with control: refraction, 0.81 [95% confifidence interval (CI), 0.58e1.04]; AXL, e0.35 [e0.46 to e0.25]); 0.5% atropine (mean differences compared with control: refraction, 0.70 [95% CI, 0.40e1.00]; AXL, e0.23 [e0.38 to e0.07]); 0.05% atropine (mean differences compared with control: refraction, 0.62 [95% CI, 0.17e1.07]; AXL, e0.25 [e0.44 to e0.06]). In terms of myopia control as assessed by relative risk (RR) for overall myopia progression, 0.05% was ranked as the most benefificial concentration (RR, 0.39 [95% CI, 0.27e0.57]). The risk for adverse effects tended to rise as the atropine concentration was increased, although this tendency was not evident for distance BCVA. No valid network was formed for near BCVA.

从16项随机对照试验(3272名参与者)中获得了30个两两比较。我们的NMA将1%、0.5%和0.05%的阿托品浓度列为3个最有利于近视控制的指标,评估了两种主要结果:1%的阿托品(与对照组相比的平均差异:屈光,0.81[95%置信区间(CI), 0.58e1.04];AXL, e0.35 [e0.46到e0.25]);0.5%阿托品(与对照组相比的平均差异:屈光度,0.70 [95% CI, 0.40e1.00];AXL, e0.23 [e0.38到e0.07]);0.05%阿托品(与对照组相比,平均差异:屈光度,0.62 [95% CI, 0.17e1.07];AXL, e0.25 [e0.44 to e0.06])。在总体近视进展的相对风险(RR)评估的近视控制方面,0.05%被列为最有益的浓度(RR, 0.39 [95% CI, 0.27e0.57])。不良反应的风险随着阿托品浓度的增加而增加,尽管这种趋势在距离BCVA中不明显。BCVA附近未形成有效网络。

Discussion

The ranking probability for effificacy was not proportional to dose (i.e., 0.05% atropine was comparable with that of high-dose atropine [1% and 0.5%]), although those for pupil size and accommodation amplitude were dose related.

疗效排名的概率与剂量无关(即0.05%阿托品与高剂量阿托品具有可比性[1%和0.5%]),尽管瞳孔大小和调节幅度与剂量相关。

推荐理由

本研究探索了8种阿托品浓度控制儿童近视的疗效和安全性得出在总体近视进展的相对风险(RR)评估的近视控制方面,0.05%被列为最有益的浓度(RR, 0.39 [95% CI, 0.27e0.57]),0.05%阿托品与高剂量阿托品具有可比性[1%和0.5%]

文章创新点是关注不同阿托品浓度,从大数据中提取合适患者进行研究,数据准确度高,通过科学的方案设计分析出阿托品浓度控制对于视力的影响

文章的不足之处为没有做患儿之间的差异性比较,可能存在偏差。

眼科创新企业卫视博再获融资,雷石投资独家注资

雷石投资近日成功完成广州卫视博生物科技有限公司的独家注资。医疗服务创新是雷石投资重点关注的赛道之一,卫视博生物科技正是一家专注于眼科高端创新产品研发、生产和销售的国家高新技术企业。
卫视博-专注于眼科创新产品的高新企业
广州卫视博生物科技有限公司成立于2007年10月30日,位于广州南沙区广东医谷产业园。公司自 2007 年成立以来,先后获得了国家 863 项目、十二五支撑计划、中小企业创新基金、广东省产学研和广州市科技计划等一系列政府基金的资助,拥有美国、澳大利亚、中国等专利 22 项。公司依托于中山眼科中心的研发平台,精心眼科创新产品的研发,其中代表产品 FCVB 是国际首创的挽救眼球的人工器官,可以精细模拟人眼玻璃体结构和功能,自2017 年上市以来,全国共计 24 个省、115 家医院、超 100位眼科医生开展了折叠式人工玻璃体球囊植入手术,服务患者2000多名。目前产品也已在国外的英国、比利时、土耳其、希腊、俄罗斯、澳大利亚、巴基斯坦、拉脱维亚等等10个国家开展了折叠式人工玻璃体球囊植入手术,临床效果良好。

优势产品-深耕眼科视网膜领域
公司主要产品包括折叠式人工玻璃体球囊(FCVB)、折叠顶压球囊(FCB)、近视后巩膜加固系统(HM)等。折叠式人工玻璃体球囊(FCVB)则是其主打优势产品。该产品用于治疗视网膜脱离和严重眼外伤,获得欧盟CE 和中国CFDA 证书,并在亚洲欧洲进行广泛临床应用。作为长期的眼内填充物,可挽救患者眼球,不需植入义眼。产品优势在于

支撑功能强,能360度支撑视网膜;

隔绝功能,避免硅油乳化和移位;

调节眼压,通过引流阀进行;

保留后房空间,不干扰睫状体。

典型患者服务病例
FCVB目前已服务患者数千名,积累了丰富的临床实战经验,以下为最近几例患者服务案例。解放军总医院第三医学中心眼科医学部成功开展人工玻璃体球囊植入手术,为一位20多岁的武警战士保住了眼球。

2021年11月30日,恩施慧宜眼科医院成功开展首例折叠式人工玻璃体球囊FCVB手术,肖紫云教授顺利为一名三年视物不见的视网膜脱离患者植入折叠式人工玻璃体球囊(FCVB)。

2021年11月3日,四川省人民医院乔利峰教授成功开展了首台折叠式人工玻璃体球囊(FCVB)手术,为一名硅油依赖眼患者成功植入FCVB,保住了患者眼球。在今年1月,四川省人民医院就已引进了此项FCVB新技术,目前已为多位眼外伤和硅油眼患者保住了眼球。

从患者回访来看,该产品确能保住患者眼球,无需眼球摘除植入义眼,维持玻璃体结构,改善患者生活质量。对于一些可能的并发症,通过标准化操作推广、医生技术标准化、术后密切观察、早发现早处理可将并发症降到最低,从而服务更多的患者。

经营管理与研发实力是公司长期增长的保障
管理团队专业、研发实力雄厚、经营能力突出将是卫视博公司持续增长的重要保障。管理团队专业:公司管理团队以熟悉机构管理、行业市场的人才为主,管理团队核心成员均具有多年企业管理、市场营销、资本运作经验,熟悉国内法律法规、政策导向以及行业发展动态,能够为公司的技术走向产业化及长期战略发展保驾护航。

研发实力雄厚:公司研发团队核心成员主要为国内知名眼科中心眼科学博士,具有多年的临床经验、研究经验及丰硕的科研成果,专业背景涉及眼科学、生物制药、高分子材料工程等诸多领域,使得公司在自主研发能力及技术创新能力上能够贴切临床实际需求且保持国际领先。已成功落地的产品、丰富的技术储备、多年的专利积累即是其实力的证明。

经营能力突出:市场与销售团队亦具有行业背景。公司成立以来取得的商业化成功即是市场经营能力的证明。

在未来的日子里,公司将以精益求精的工匠精神,创立我们民族自己的专业品牌,致力于成为集眼科研究、新技术研发、生产制造、销售和眼科临床服务等功能一体的国际化创新医疗企业。

雷石投资持续致力于投资高质量和可信赖的医疗健康服务领域,研发创新型企业是我们的首选。欢迎更多企业加入雷石投资阵营,我们将与众多创新型企业共同成长。

【本文转自:雷石投资

【直播回顾】新视界跨学科名医论坛第一期

昨日(10月21日)晚上,新视界跨学科名医论坛第一期直播圆满结束。4位中山大学中山眼科中心不同学科专家,眼外伤科林晓峰教授担任主持嘉宾,白内障科郑丹莹教授、屈光与低视力科杨晓教授、角膜科梁凌毅教授,就“角膜损伤后散光的产生及处理”进行深度访谈,探讨不规则散光的类型、早期干预办法、后期解决方案,以及针对散光的创新治疗等内容,为大家提供了一场精彩的学术盛宴!值得一提的是,在直播中有多人陆续进行线上提问,各位教授也一一进行解答。以下为直播视频,点击可观看▽、
此次直播共有2个平台同步直播,线上共计3226人观看。
01格度医云
最高同时在线1468人并发观看;会议期间累计观看人数约为:2739人,覆盖地区逾18个。
02医事公开课
观看人数:487人。
也可扫码进入直播间观看回放
栏目简介●●●
 名医论坛
搭建跨越不同学科的学术平台,邀请各学科领域专家学者,每期以各学科热点难点话题,探讨疑难病例、创新产品与技术,进行多元化交流,展现学术风采。
  特色板块 
名医面对面>>各界名医无缝交流,高峰论坛碰撞思想火花跨学科产品速递>>名医深度解析不同学科创新产品和技术

【直播回顾】新视界跨学科名医论坛第二期

昨日(12月02日)晚上,新视界跨学科名医论坛第二期直播圆满结束。4位中山大学中山眼科中心不同学科专家,眼外伤科林晓峰教授担任主持嘉宾,眼整形科黄丹平教授、眼底外科胡洁教授、眼外伤科&急症科娄秉盛教授,就“硅油依赖眼的出路在哪里?”进行深度访谈,为大家提供了一场精彩的学术盛宴。四位专家针对什么是硅油依赖眼,硅油依赖眼的形成原因及治疗方式,尤其是创新治疗植入折叠式人工玻璃体球囊治疗进行讲解。在直播间许有多人在线上提问,各位教授也一一进行解答,直播间异常火爆。
可直接扫码进入直播间观看回放

此次直播共有2个平台同步直播,观看数据如下:
01格度医云
最高同时在线1963人并发观看;会议期间累计观看人数约为:3547人,覆盖地区逾30个。
02医师服务
观看人数:329人,观看次数414次,覆盖多个地区。
此前在10月21日,开展了第一期直播探讨“角膜损伤后散光的产生及处理”,共有三千多人观看,获得了广泛关注,进入直播间也可观看第一期视频回顾。第三期名医论坛将在2022年1月6日举行,敬请期待! 

栏目简介●●●
 名医论坛
搭建跨越不同学科的学术平台,邀请各学科领域专家学者,每期以各学科热点难点话题,探讨疑难病例、创新产品与技术,进行多元化交流,展现学术风采。
  特色板块 
名医面对面>>各界名医无缝交流,高峰论坛碰撞思想火花跨学科产品速递>>名医深度解析不同学科创新产品和技术

【直播回顾】新视界跨学科名医论坛第三期

1月25日晚上,新视界跨学科名医论坛第三期直播圆满结束!中山大学中山眼科中心不同学科的四位专家,眼底外科胡洁教授担任主持嘉宾联袂白内障科罗莉霞教授、小儿眼病&眼底外科丁小燕教授和眼外伤科何丽文教授,放眼眼科历史之河,回眸过往,共同对眼科重大发明发现进行多维度深度讨论与解析。

四位教授齐聚一堂,分别从古代萌芽、16世纪至18世纪奠基、近代19世纪独立发展、 20世纪飞速发展和现代中国眼科发展时期分享了眼底外科、白内障科和眼外伤科中里程碑式的人物故事和发明技术。四位专家深入浅出、风趣幽默,带领我们徜徉眼科历史长河,欣赏一颗颗熠熠生辉的“明珠”。如:近代眼视光学的奠基者开普勒( Kepler )、眼生理学之父托马斯·扬(Thomas Young ) 、超乳的发明者Charles D. Kelman、视网膜脱离之父Jules Gonin等等,欲知更多,欢迎扫码观看~▽▽


△识别二维码进观看视频

此次直播共有2个平台同步直播,观看数据如下:

01 格度医云公众号

最高同时在线1040人并发观看;会议期间累计观看人数约为2173人,覆盖地区逾15个。

02 医师服务AP

观看人数582人,观看人次1326人。

此前在2021年,名医论坛共开展两期直播,分别为“角膜损伤后散光的产生及处理”和“硅油依赖眼的出路在哪里?”,共有五千多人观看实时直播。未来,卫视博还将以北京、上海为直播基地,邀请全国各地专家名医进行直播分享,敬请期待!

名医论坛

搭建跨越不同学科的学术平台,邀请各学科领域专家学者,每期以各学科热点难点话题,探讨疑难病例、创新产品与技术,进行多元化交流,展现学术风采。

特色板块:

名医面对面>>各界名医无缝交流,高峰论坛碰撞思想火花

跨学科产品速递>>名医深度解析不同学科创新产品和技术

 

名医论坛系列仍在进行人气话题火热征集中,您想了解什么学科什么话题?热点资讯?疑难病例?创新技术?

欢迎留言或发送想了解的学术话题,进行话题提名,我们将选取大家关注的人气话题,特邀该领域专家名医为您解答!

长按下方二维码可直接进入直播间

年终盘点 | 卫视博2021大事件,感谢您的一路同行!

2021年波折迭起,虽仍有疫情和灾难交织,但感动与收获同在。让我们回顾年终总结,

积攒温暖,与光同行!

01
专精特新企业
入库广州市专精特新企业
02
国内FCVB临床应用新进展
2021年,复旦大学附属眼耳鼻喉科医院等多家医院成功开展首例FCVB手术,至今已有两百多家医院引进FCVB新技术,为广大眼外伤和硅油依赖眼患者保住眼球。
03
FCVB新技术病例研讨会
卫视博陆续在全国各地开展新技术讨论会,覆盖多个地区。此外,举办了重症眼外伤处理暨折叠式人工玻璃体球囊进展学习班,探讨重症眼外伤处理和FCVB新技术。
04
FCVB参展&卫星会
卫视博参展Retina China 2021,举办卫星会。国家眼部疾病临床医学研究中心主任、中华医学会眼科学分会眼底病学组组长许迅教授,空军军医大学西京医院惠延年教授和北京同仁医院魏文斌教授作为卫星会主席,北京同仁医院王绍莉教授、复旦大学附属眼耳鼻喉科医院江睿教授、哈尔滨医科大学附属第二医院孙大卫教授分享FCVB病例。
05
FCVB入选三级公立医院绩效考核四级手术目录(2019版)
序号:341手术操作编码:14.7203手术操作描述:后入路玻璃体切割术伴人工玻璃体置入术
06
电视台报道新技术
中央广播电视总台综合频道(CCTV-1)报道创新医疗新技术《人工玻璃体球囊 保住萎缩的眼球》,由首都医科大学附属北京同仁医院史翔宇教授结合动画讲解“折叠式人工玻璃体球囊”是如何保住眼球萎缩的眼睛。
广东经济频道《广东新焦点》栏目报道广州卫视博公司科技创新促发展,首创折叠式人工玻璃体球囊技术保眼球。
07
FCB多中心临床研究新进展
多家医院同步开展FCB多中心临床研究,取得新进展。
08
高度近视后巩膜加固系统
首都医科大学附属北京同仁医院、首都医科大学附属北京友谊医院、温州医科大学附属眼视光医院、广州中医药大学第一附属医院已正式开展高度近视后巩膜加固系统探索性临床试验,取得突破性进展。

9月 | Vesber 最佳RIO论文推荐

卫视博每月从三大权威杂志:Retina、Investigative Ophthalmology & Visual Science、Ophthalmology中各推荐一篇眼科论文。— — 最佳“RIO”论文推荐(9月)Evaluation of the efficacy of posterior scleral contraction in the treatment of macular hole with retinal detachment in high myopia Macular surgery on sclera(Ye J, Wu Y, Zhu S, et al. EVALUATION OF THE EFFICACY OF POSTERIOR SCLERAL CONTRACTION IN THE TREATMENT OF MACULAR HOLE WITH RETINAL DETACHMENT IN HIGH MYOPIA. Retina. 2021;41(9)_1874-1882.)
后巩膜收缩术治疗高度近视黄斑裂孔合并视网膜脱离的手术疗效评价
Purpose
To evaluate efficacy of posterior scleral contraction (PSC) for macular hole withretinal detachment (MHRD) in high myopia.评价后巩膜收缩术(PSC)治疗高度近视黄斑裂孔合并视网膜脱离(MHRD)的疗效。
Methods
Seventy-three MHRD eyes were treated with PSC. A strip was sent across inferiortemporal scleral surface to posterior pole, then two ends were led out from nasal-inferior and temporal-superior areas. It was tightened to contract posterior sclera with designed axial length (AL) shortening ([10% of pre-operative AL-0.5]mm) after aqueous humors drained from anterior chamber. Recovery was classified as type I (retinal reattachment with MH bridged) and II (retinal reattachment without MH bridged). Follow-up duration was 25.3±18.0 months.73只高度近视黄斑裂孔合并视网膜脱离眼接受后巩膜收缩术治疗。将条带穿过颞下巩膜面至后极,然后从鼻下区和颞上区引出两端。前房排出房水后,用设计的轴向长度(AL)缩短法([10%术前轴向长度-0.5]mm)收紧后巩膜,以收缩后巩膜。恢复类别分为I型(黄斑裂孔桥接的视网膜复位)和II型(无黄斑裂孔桥接的视网膜复位)。随访时间为25.3±18.0个月。
Results
AL was 30.01±2.27mm at pre-operation and shortened by 2.57±0.82mm intraoperatively. At final post-operation, maintained AL shortening was 1.87±0.92mm. Forty-six eyes (63.0%) recovered as type I and 26 eyes (35.6%) as type II, 1 eye (1.4%) unrecovered. Postoperative best-corrected visual acuity (BCVA, logarithm of minimal angle of resolution [LogMAR]) was better than pre-operative one (0.85±0.50 [Snellen 20/125] vs. 1.11±0.56 [Snellen 20/250], P<0.001) with correlation (r=0.662, P<0.001) and consistency (Kappa=0.34, P<0.001) between two. BCVA improvement didn’t differ between recovery types (P=0.206).术前轴向长度为30.01±2.27mm,术中缩短2.57±0.82mm。术后最后一次手术时,维持的轴向长度缩短为1.87±0.92mm。46只眼(63.0%)恢复为I型,26只眼(35.6%)恢复为II型,1只眼(1.4%)未恢复。术后最佳矫正视力(BCVA,最小分辨角对数[LogMAR])优于术前(0.85±0.50[Snellen 20/125]vs.1.11±0.56[Snellen 20/250],P<0.001),两者之间具有相关性(r=0.662,P<0.001)和一致性(Kappa=0.34,P<0.001)。恢复类型之间的术后最佳矫正视力改善没有差异(P=0.206)。
Conclusion
MHRD was successfully recovered by PSC with AL shortening. Visual improvement was achieved, correlated and consistent with pre-operative BCVA while independent of recovery types.黄斑裂孔伴视网膜脱离通过后巩膜收缩和轴向长度缩短成功恢复。视力得到改善,与术前最佳矫正视力一致,且与恢复类型无关。
本文研究了高度近视黄斑裂孔伴视网膜脱离患者采用巩膜加压术进行治疗,术后视网膜复位,眼轴缩短,手术治疗效果好。本文创新之处在于对比了术后不同类型的恢复与最佳矫正视力之间的关系,得出恢复类型与视力之间不具相关性。
文章不足之处在于文章病例随访时间显示,手术末次随访的眼轴数据较术中缩短的数据缩短的区间有所降低,对于更远期的随访,比如5年、10年是否依旧能够维持是个未知数,需进一步随访观察。
No.2
Investigative Ophthalmology & Visual Science · 推荐
COVID-19 Home Quarantine Accelerated the Progression of Myopia in Children Aged 7 to 12 Years in China( Ma M, Xiong S, Zhao S, Zheng Z, Sun T, Li C. COVID-19 Home Quarantine Accelerated the Progression of Myopia in Children Aged 7 to 12 Years in China. Invest Ophthalmol Vis Sci. 2021;62(10)_37.)
新冠病毒-19家庭隔离加速了中国7-12岁儿童近视的发展
Purpose
To investigate the effect of home quarantine during the COVID-19 pandemic on myopia progression in children and its associated factors.探讨在COVID-19大流行期间,家庭隔离对儿童近视进展的影响及其相关因素。
Methods
Myopic children aged 7 to 12 years with regular follow-up visits every half a year from April 2019 to May 2020 were included. Cycloplegic refraction was measured at baseline and at two follow-up visits. The first follow-up visit (visit 1) was conducted before the COVID-19 home quarantine, whereas the second (visit 2) was four months after the home quarantine. Myopia progression at visits 1 and 2 were compared. Factors associated with changes in myopia progression were tested with a multiple regression analysis.包括2019年4月至2020年5月每半年定期随访的7至12岁近视儿童。在基线检查和两次随访时测量睫状肌麻痹性屈光。第一次随访(第1次随访)是在COVID-19家庭隔离之前进行的,而第二次随访(第2次随访)是在家庭隔离四个月之后进行的。比较第1次和第2次就诊时的近视进展情况。用多元回归分析测试与近视进展变化相关的因素。
Results
In total, 201 myopic children were enrolled. There was a significantly greater change in spherical equivalent at visit 2 (−0.98 ± 0.52 D) than at visit 1 (−0.39 ± 0.58 D; P < 0.001). Students were reported to have spent more time on digital devices for online learning (P < 0.001) and less time on outdoor activities (P < 0.001) at visit 2 than at visit 1. Children using television and projectors had significantly less myopic shift than those using tablets and mobile phones (P < 0.001). More time spent on digital screens (β = 0.211, P < 0.001), but not less time on outdoor activities (β = −0.106, P = 0.110), was associated with greater myopia progression at visit 2.总共有201名近视儿童入选。在第2次就诊时(−0.98±0.52 D),比第1次随访时(−0.39±0.58天;P<0.001)球面当量的变化显著更大。据报道,与第1次随访相比,第2次随访的学生在用于在线学习的数字设备上花费的时间更多(P<0.001),而在户外活动上花费的时间更少(P<0.001)。与使用平板电脑和手机的儿童相比,使用电视和投影仪的儿童近视转移明显减少(P<0.001)。在第2次随访时发现,控制户外活动的时间不降低(β=−0.106,P=0.110),但是在数字屏幕上花费的时间增加(β=0.211,P<0.001),近视进展同样显著。
Conclusion
Changes in behavior and myopic progression were found during the COVID-19 home quarantine. Myopic progression was associated with digital screen use for online learning, but not time spent on outdoor activities. The projector and television could be better choices for online learning.在COVID-19居家隔离期间发现了行为和近视进展的变化。近视进展与在线学习使用数字屏幕有关,但与户外活动时间无关。投影仪和电视可能是在线学习的更好选择。
本文研究了新冠疫情期间,居家隔离的防控政策对教学方式的改变进一步影响了儿童近视的发展,得出数字屏幕的使用时间与近视的发展想关。文章创新之处在于通过借助社会环境改变的背景设置变量,收集到数字屏幕的使用时长与近视关联,得出针对该环境下更有利于控制近视防控的建议。本文的不足之处在于仅分析了儿童屈光度的进展改变,未收集其他数据改变,例如视力,未来可进一步丰富研究内容。
No.3
Ophthalmology · 推荐
Bidirectional Association between Visual Impairment and Dementia Among Older Adults in the United States Over Time(Chen SP, Azad AD, Pershing S. Bidirectional Association between Visual Impairment and Dementia Among Older Adults in the United States Over Time. Ophthalmology. 2021;128(9)_1276-1283.)
随着时间的推移,美国老年人视力障碍和痴呆症之间的相互影响
Purpose
Although visual impairment (VI) has been associated with worse cognitive performance among older adults, the temporal relationship between the 2 remains subject to debate. Our objective was to investigate the longitudinal impact of VI on cognitive function and vice versa.尽管视力障碍(VI)与老年人的认知能力较差(老年痴呆症)有关,但两者之间的先后影响关系仍存在争议。我们的目的是研究视力障碍与老年痴呆症的相互影响关系。
Design
Retrospective, time-to-event study.回顾性、事件时间研究。
Participants
National Health and Aging Trends Study (NHATS) participants from 2011 to 2018 cycles.参与者为入选2011年至2018年国家健康和老龄化趋势研究(NHAT)的人员。
Methods
A total of 10 676 participants aged 65 years and older were included. Cox proportional hazards regression models evaluated the impact of baseline VI on subsequent dementia and impact of baseline dementia on subsequent VI. Models were adjusted for potential confounding variables, including demographics, clinical comorbidities, and hearing and physical function limitations.共有10676名65岁及以上的参与者被纳入研究。采用考克斯比例风险回归模型,评估初始视力障碍人群继发痴呆的概率以及初始痴呆患者后续继发视力障碍的概率。模型针对潜在的混杂变量进行干扰排除,包括人口统计学、临床共病、听力和身体功能限制。
Main Outcome Measures
Hazard ratio (HR) for incident dementia among participants with baseline selfreported VI and HR for incident VI among participants with baseline dementia.初始视力损害参与者中继发痴呆的比例和初始痴呆参与者中继发视力损害的比例。
Results
Of the 10 676 participants included in the analysis, approximately 40% were aged 65-74 years, 40% were aged 75-84 years, and the remaining 20% were aged 85 years and older. The majority were female (59%), and 68% self-identifified as non-Hispanic White. Among participants with normal cognitive status at baseline, subsequent dementia was observed in 1753 (16%), and among participants with normal self-reported vision at baseline, subsequent VI was reported in 2371 (22%). In adjusted regression models, participants with baseline VI had higher likelihood of developing dementia over subsequent follow-up (HR, 2.3; 95% confifidence interval [CI], 2.0e2.6; P < 0.001). Likewise, participants with baseline dementia had a higher likelihood of developing self-reported VI over time (HR, 2.5; 95% CI, 2.2e2.8; P < 0.001).在纳入分析的10676名参与者中,约40%的人年龄在65-74岁,40%的人年龄在75-84岁,其余20%的人年龄在85岁及以上。大多数是女性(59%),68%的非西班牙裔白人。在初始检查时非老年痴呆症的参与者中,1753人(16%)出现继发性痴呆,在初始检查时视力正常的参与者中,2371人(22%)出现继发性视力障碍。在调整后的回归模型中,初始为视力障碍的参与者在随后的随访中发生痴呆的可能性更高(HR,2.3;95%可信区间[CI],2.0-2.6;P<0.001)。同样,初始痴呆患者随着时间的推移出现视力障碍的可能性也更高(HR,2.5;95%CI,2.2-2.8;P<0.001)。
Conclusion
Self-reported VI in the US Medicare population is associated with greater dementia likelihood over time, and dementia is similarly associated with greater VI likelihood over time. Associations are likely multifactorial and bidirectional and could be explained by intervening variables in the path from VI to dementia, or vice versa, or by common risk factors for pathological processes in both eyes and brain. These fifindings suggest the need for early identifification of older adults with visual compromise and consideration of visual disability in the cognitively impaired.美国医疗保险人群中视力障碍患者继发老年痴呆有更大的可能性,而痴呆症随着时间的推移继发视力障碍也有更大的可能性。该影响可能是多因素和双向的,可以通过从视力障碍与痴呆的途径中的干预变量来解释,或者通过眼睛和大脑病理过程的共同风险因素来解释。这些发现表明,有必要早期识别患有视力损害的老年人,并重视痴呆患者的视力障碍。
推荐理由
本研究探索了美国老年人视力障碍和痴呆症之间的双向关联,得出两者之间的关系是双向的,相互影响。文章创新点是通过数万人的大样本统计数据进行概率分析,发现视力障碍的参与者继发痴呆的可能性比非视力障碍者更高。痴呆患者继发视力障碍的可能性比非痴呆参与者更高。文章的不足之处为变量因素复杂,尽管在统计学中排除了无关变量,但是对于一些多因素综合影响的结果,无关变量并不是绝对的无关因素,未来须从多个角度,多个方向继续探讨。

10月 | Vesber 最佳RIO论文推荐

卫视博每月从三大权威杂志:Retina、Investigative Ophthalmology & Visual Science、Ophthalmology中各推荐一篇眼科论文。— — 最佳“RIO”论文推荐(10月)

No.1
Retina · 推荐
FULL-THICKNESS MACULAR HOLE IN AGE-RELATED MACULAR DEGENERATION PATIENTS WITH TWO DISTINCT ENTITIES(Retina. 2021;41(10):2066-2072.)

年龄相关性黄斑变性患者的全厚度黄斑裂孔,有两种不同的表现
Purpose
To describe optical coherence tomography characteristics of full-thickness macular holes (FTMHs) in age-related macular degeneration patients.描述年龄相关性黄斑变性患者全厚度黄斑裂孔(FTMHs)的光学相干断层扫描特征。

Methods
A multicenter, retrospective, observational case series of patients diagnosed with age-related macular degeneration and FTMHs seen between January 1, 2009, and January 3, 2020. Clinical charts and spectral-domain optical coherence tomography images were reviewed. Optical coherence tomography findings included FTMH-inverted trapezoid or hourglass appearance, central macular thickness (CMT), complete retinal pigment epithelium and complete retinal outer retinal atrophy, and presence of pigment epithelium detachment and epiretinal membrane. The mean outcome was the morphologic and functional characterization of different subtypes of FTMHs.2009年1月1日至2020年1月3日期间诊断为年龄相关性黄斑变性和FTMHs患者的多中心、回顾性、观察性病例系列。回顾了临床图表和光谱域光学相干断层扫描图像。光学相干断层扫描结果包括FTMH倒梯形或沙漏状外观、中央黄斑厚度(CMT)、完整的视网膜色素上皮和完整的视网膜外萎缩、色素上皮脱离和视网膜前膜。平均结果是不同亚型FTMHs的形态和功能特征

Results
A total of 86 eyes of 85 consecutive patients, with mean age of 80.31 ± 8.06 and mean best-corrected visual acuity of 1.17 ± 0.58 logarithm of the minimal angle of resolution. Two different subtypes of FTMHs were identified: tractional and degenerative. Fifty (58%) degenerative FTMHs characterized with inverted trapezoid appearance and 36 (42%) tractional FTMHs characterized with hourglass appearance. Degenerative FTMHs presented with 66% of CMT < 240µm, 14% of CMT > 320, and 70% of complete retinal outer retinal atrophy, in comparison with 41% of CMT < 240µm, 42.9% of CMT > 320%, and 20% of complete retinal outer retinal atrophy in the tractional FTMH group (P= 0.002, 0.003, <0.001, respectively). The presence of epiretinal membrane and pigment epithelium detachment where significantly higher in tractional FTMHs (P= 0.02, 0.03, respectively).85名连续患者共86只眼,平均年龄为80.31±8.06岁,平均最佳矫正视力为最小分辨角对数的1.17±0.58。确定了两种不同的FTMHs亚型:牵引型和退行性。50例(58%)退行性FTMHs表现为倒梯形,36例(42%)牵引性FTMHs表现为沙漏状。与牵引性FTMH组中41%的CMT<240µm、42.9%的CMT>320%和20%的完全性视网膜外萎缩相比,退行性FTMH表现为66%的CMT<240µm、14%的CMT>320和70%的完全性视网膜外萎缩(分别P=0.002、0.003和<0.001)。在牵引性FTMHs中,视网膜前膜和色素上皮脱离的出现率明显较高(分别为P=0.02和0.03)。

Conclusion
Degenerative and tractional FTMHs may be two distinct clinical entities. Discerning degenerative from tractional FTMHs is possible by using optical coherence tomography features including shape of the FTMHs, CMT, internal–external ratio of FTMHs, and presence of complete retinal outer retinal atrophy, pigment epithelium detachment, and epiretinal membrane.Full-thickness macular holes in age-related macular degeneration patients can be divided into tractional and degenerative subgroups. Discerning degenerative from tractional full-thickness macular holes is possible by using optical coherence tomography features including shape of the full-thickness macular holes, central macular thickness, presence of complete retinal outer retinal atrophy, pigment epithelium detachment, and epiretinal membrane.

退行性和牵引性FTMHs可能是两种不同的临床实体。通过光学相干断层扫描特征,包括FTMHs的形状、CMT、FTMHs的内外比、完全性视网膜外萎缩、色素上皮脱离和视网膜前膜,可以区分牵引性FTMHs和退行性FTMHs。

年龄相关性黄斑变性患者的全厚度黄斑裂孔可分为牵引性和变性亚组。通过光学相干断层扫描特征,包括全厚度黄斑裂孔的形状、中央黄斑厚度、是否存在完全的视网膜外萎缩、色素上皮脱离和视网膜前膜,可以区分牵引性全厚度黄斑裂孔和退行性全厚度黄斑裂孔。

该研究帮助临床医生区分了牵引性FTMHs和退行性FTMHs的两种不同表现,文章的创新之处在于通过一年时间的回顾分析86只眼的FTMHs的形状、中央黄斑厚度、是否存在完全的视网膜外萎缩、色素上皮脱离和视网膜前膜的光学相干断层扫描结果,确定了两种不同的FTMH亚型,分别为牵引型和退行性。

文章的不足之处在于虽然描述并比较了牵引性和退行性FTMHs的特征,但没有对接受PPV的患者进行随访,包括视力变化和手术结果。为了更好地了解牵引性和退行性FTMHs的病理生理学和阶段,还需要进行更大规模的前瞻性研究。

No.2
Investigative Ophthalmology & Visual Science · 推荐
Impacts of Systemic Hypertension on the Macular Microvasculature in Diabetic Patients Without Clinical Diabetic Retinopathy( Invest Ophthalmol Vis Sci. 2021;62(12):21.)

全身性高血压对无临床糖尿病视网膜病变的糖尿病患者黄斑微血管的影响
Purpose
Purpose: To identify the impact of hypertension (HTN) on macular microvasculature in type 2 diabetes (T2DM) patients without clinical diabetic retinopathy.探讨高血压(HTN)对无临床糖尿病视网膜病变的2型糖尿病(T2DM)患者黄斑微血管的影响。

Methods
 In this retrospective cross-sectional study, subjects were divided into three groups: controls (control group), patients with T2DM (DM group), and patients with both T2DM and HTN (DM + HTN group). The vessel length density (VD) was compared among the groups. Linear regression analyses were performed to identify factors associated with VD.在这项回顾性横断面研究中,受试者分为三组:对照组(对照组)、2型糖尿病患者(糖尿病组)和2型糖尿病合并HTN患者(糖尿病+HTN组)。比较各组间血管长度密度(VD)。进行线性回归分析以确定与VD相关的因素。

Results
 The VD in the control, DM, and DM + HTN groups was 20.43 ± 1.16, 19.50 ± 1.45, and 18.19 ± 2.06 mm−1, respectively (P < 0.001). The best-corrected visual acuity (B = −9.30; P = 0.002), duration of T2DM (B = −0.04; P = 0.020), HTN (B = −0.51; P = 0.016), signal strength (B = 1.12; P < 0.001), and ganglion cell–inner plexiform layer thickness (B = 0.06; P < 0.001) were significant factors affecting VD in patients with T2DM. Additionally, the hemoglobin A1c (HbA1c) (B = −0.49; P = 0.016) was significantly associated with VD in patients with both T2DM and HTN.对照组、DM组和DM+HTN组的VD分别为20.43±1.16、19.50±1.45和18.19±2.06mm−分别为1例(P<0.001)。最佳矫正视力(B=−9.30;P=0.002),T2DM持续时间(B=−0.04;P=0.020),HTN(B=−0.51;P=0.016)、信号强度(B=1.12;P<0.001)和神经节细胞-内丛状层厚度(B=0.06;P<0.001)是影响T2DM患者VD的重要因素。此外,血红蛋白A1c(HbA1c)(B=−0.49;P=0.016)与T2DM和HTN患者的VD显著相关。

Conclusion
Patients with T2DM had impaired macular microvasculature, and patients with T2DM with HTN exhibited greater impairment of the microvasculature than did patients with T2DM only. Additionally, physicians should be aware that the macular microvasculature would be more vulnerable to hyperglycemic damage under ischemic conditions by HTN.T2DM患者的黄斑微血管受损,T2DM合并HTN患者的微血管受损程度高于单纯T2DM患者。此外,医生应意识到,在HTN引起的缺血条件下,黄斑微血管更容易受到高血糖损伤。

本研究将受试者分为三组进行对照研究,研究结果表明,与健康个体相比,T2DM患者的黄斑微血管系统受损,并且T2DM合并HTN患者表现出比单纯的T2DM患者更严重的微血管损伤。本文的创新之处在于使用了信号强度相对较高的OCTA图像,可以进行准确的分析。此外,很少有研究报告HTN对T2DM患者黄斑微血管系统的影响。

不足之处在于没有确定受损的黄斑微血管系统与视觉功能的各个方面之间的关系,并且无法排除研究患者之前曾发生过HTN视网膜病变但随后消退,这点可能会影响黄斑微血管系统数据。

No.3
Ophthalmology · 推荐
Panretinal Photocoagulation for Diabetic Retinopathy in the RIDE and RISE Trials: Not “1 and Done”(Ophthalmology. 2021;128(10):1448-1457.)

RIDE and RISE试验中糖尿病视网膜病变的全视网膜光凝治疗:不是“1且完成”
Purpose
To evaluate panretinal photocoagulation (PRP) treatment and re-treatment patterns in patients with diabetic retinopathy (DR) and diabetic macular edema (DME).评估糖尿病视网膜病变(DR)和糖尿病黄斑水肿(DME)患者的全视网膜光凝(PRP)治疗和再治疗模式。

Design
Post hoc analysis of the phase 3 RIDE (clinicaltrials.gov identifier,NCT00473382) and RISE (clinicaltrials.gov identifier,NCT00473330) clinical trials of ranibizumab for the treatment of DME.雷尼珠单抗治疗二甲醚的3期临床试验(clinicaltrials.gov标识符,NCT00473382)和RISE(clinicaltrials.gov标识符,NCT00473330)的事后分析。

Participants
Seven hundred fifty-nine patients were randomized for treatment.参与者:759名患者随机接受治疗。

Methods
Panretinal photocoagulation treatment patterns and clinical experiences were assessed by baseline PRP treatment status.通过基线PRP治疗状态评估全视网膜光凝治疗模式和临床经验。

Main Outcome Measures
Number and timing of on-study PRP treatment sessions undergone through month 24. Time to new proliferative event (composite end point) was also assessed.第24个月期间进行的研究中PRP治疗的次数和时间安排。还评估了发生新的增殖事件(复合终点)的时间。

Results
At baseline, approximately 25% of patients in RIDE and RISE had undergone PRP treatment before enrollment (22.2%, 24.4%, and 25.4% of patients in the sham, ranibizumab 0.3 mg, and ranibizumab 0.5 mg arms, respectively). In patients without prior PRP at baseline (n = 577), 9.5% of sham-treated patients underwent 1 or more PRP treatments through month 24, compared with 1.1% and 1.6% of patients receiving ranibizumab 0.3 mg and ranibizumab 0.5 mg, respectively (P < 0.001 for both ranibizumab arms vs. sham). In patients with prior PRP at baseline (n = 182), 19.3% of sham-treated patients underwent 1 or more PRP treatments through month 24. No ranibizumab-treated patients with prior PRP at baseline required additional on-study PRP through month 24 (P < 0.001 for both ranibizumab arms vs. sham). Ranibizumab treatment also significantly reduced clinical DR progression among patients who underwent prior PRP. By month 24 in patients with prior PRP at baseline, the probability of experiencing a new proliferative event was 10.3% and 9.9% in patients receiving ranibizumab 0.3 mg and ranibizumab 0.5 mg treatment, respectively, compared with 39.4% in sham-treated patients (P < 0.0001). Overall, sham-treated patients, including those patients who were PRP naïve at baseline who went on to require PRP, experienced more clinical events than ranibizumab-treated patients.在基线检查时,约25%的RIDE和RISE患者在入组前接受过PRP治疗(假手术组、0.3 mg雷尼珠单抗组和0.5 mg雷尼珠单抗组分别为22.2%、24.4%和25.4%)。在基线检查时无PRP的患者中(n=577),9.5%的假手术治疗患者在24个月内接受了1次或多次PRP治疗,而接受0.3 mg雷尼珠单抗和0.5 mg雷尼珠单抗治疗的患者分别为1.1%和1.6%(雷尼珠单抗组和假手术组的P<0.001)。在基线检查时有PRP病史的患者中(n=182),19.3%的假手术患者在24个月内接受了1次或更多的PRP治疗。在基线检查时有PRP病史的患者,在研究第24个月期间,无需接受雷尼珠单抗治疗的患者需要额外的PRP研究(雷尼珠单抗组和假手术组的P<0.001)。雷尼珠单抗治疗也显著降低了既往PRP患者的临床DR进展。在基线检查时有PRP病史的患者中,到第24个月时,接受0.3 mg雷尼珠单抗和0.5 mg雷尼珠单抗治疗的患者发生新的增殖事件的概率分别为10.3%和9.9%,而接受假治疗的患者发生新的增殖事件的概率为39.4%(P<0.0001)。总的来说,假手术治疗的患者,包括那些在基线检查时PRP幼稚并继续需要PRP的患者,比雷尼单抗治疗的患者经历更多的临床事件。

Conclusion
In RIDE and RISE, PRP treatment was not a “1 and done” procedure, with on-study PRP re-treatment occurring in patients both with and without prior PRP treatment at baseline. Ranibizumab treatment reduced on-study PRP treatment and DR progression regardless of prior PRP treatment status at baseline.在RIDE and RISE中,PRP治疗不是一个“一劳永逸”的过程,在基线检查时,既往接受过PRP治疗的患者和未接受过PRP治疗的患者都会进行研究中的PRP再治疗。无论基线检查时PRP治疗前的状态如何,研究中PRP治疗和DR进展的雷尼珠单抗治疗均减少。

推荐理由
本研究分为3个治疗组(假手术组、雷珠单抗0.3毫克、雷珠单抗0.5毫克),根据基线PRP状态进行分析。在治疗组之间比较PRP治疗事件的数量和时间,为了更好地理解既往PRP治疗与DR恶化之间的关系,使用先前描述的新增殖事件的复合终点时间对既往PRP患者进行DR恶化评估。发现雷珠单抗治疗延迟了发生新增殖事件的时间。 本研究的创新之处在于本研究结果挑战了PRP是一次性手术的看法,与PRP相比,抗VEGF治疗可改善视力、解剖和DR严重程度。并建议临床中在评估PDR患者时,可考虑将雷珠单抗治疗作为独立的选择或与PRP一起使用。 本研究不足之处是在雷珠单抗组中接受研究中PRP的患者数量很少,这限制了组间比较。
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