dry eye

干眼
  • 文章类型: Journal Article
    当前研究的目的是调查热脉动治疗的疗效,在白内障手术前一个月完成,作为消除或显著减轻白内障手术对干眼患者的恶化影响的手段。
    格伦代尔,亚利桑那.
    预期,纵向,非蒙面,随机临床调查。
    治疗组在立即进行序贯治疗前约1个月接受热搏动治疗,当天双侧白内障手术。对照组不接受术前热脉动,但以相同的方式进行了白内障手术。大约1个月后,他们的基线访问。在基线时评估主观问卷和客观临床结果,治疗组与对照组分别于白内障术后1、3、6个月进行治疗。
    总共62名患者被随机分为两组,每组31只,代表124只眼。在OSDI和SPEEDII评分的治疗组中观察到主观改善。OSDI的平均值(SD)从第1次就诊的56.98(18.30)显着提高(p<0.01)到第4次就诊的14.73(12.22),并且SPEEDII评分的平均值(SD)显着提高(p=0.01)从第1次就诊的13.84(6.12)到第4次就诊的7.1(5.00)。
    对MGD继发干眼患者的术前热脉动治疗似乎可以减轻白内障手术后的干眼症状。在白内障手术后3个月之前,症状的减轻似乎减轻了,这一事实应使期望得到缓解。
    UNASSIGNED: The aim of the current study was to investigate the efficacy of Thermal pulsation treatment, completed one month prior to cataract surgery, as a means of eliminating or significantly mitigating the exacerbating effects of cataract surgery on dry eye patients.
    UNASSIGNED: Glendale, Arizona.
    UNASSIGNED: Prospective, longitudinal, non-masked, randomized clinical investigation.
    UNASSIGNED: The treatment group received Thermal pulsation therapy approximately 1 month prior to undergoing immediate sequential, same-day bilateral cataract surgery. The control group did not receive pre-operative Thermal pulsation but had cataract surgery performed in the same way, approximately 1 month after their baseline visit. Subjective questionnaires and objective clinical findings were evaluated at baseline, 1, 3, and 6 months after cataract surgery in the treatment group and control group.
    UNASSIGNED: A total of 62 patients were randomized into two groups of 31 representing 124 eyes. Subjective improvement was observed in the treatment group with OSDI and SPEED II scores. Mean (SD) of the OSDI improved significantly (p<0.01) from 56.98 (18.30) from visit 1 to 14.73 (12.22) at visit 4, and the mean (SD) of the SPEED II scores improved significantly (p=0.01) from 13.84 (6.12) during visit 1 to 7.1 (5.00) at visit 4 in the treatment group.
    UNASSIGNED: Pre-operative Thermal pulsation treatment in patients with dry eye secondary to MGD appears to reduce dry eye symptoms after cataract surgery. Expectations should be moderated by the fact that the reduction in symptoms appears to reduce prior to 3 months post-op after cataract surgery.
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  • 文章类型: Journal Article
    这项研究的目的是研究透明质酸钠(SH)联合普拉洛芬治疗干眼症患者的临床应用。
    纳入了2020年3月至2022年5月在昆山市中医医院治疗的117例干眼症患者。根据治疗方法,他们用SH治疗(SH组),普拉洛芬(普拉洛芬组),SH联合普拉洛芬(联合组)(n=39)。
    干眼的有效率为79.49%,SH组74.36%和94.87%,普拉洛芬组和联合组,分别为(p<0.05)。治疗后,联合组的泪液BUT和SIT均明显高于其他两组(p<0.05)。联合组治疗后角膜荧光素染色和干眼症状评分明显低于其他两组(p<0.001)。治疗后,视觉对比敏感度(12c/d,联合组18c/d和24c/d)明显高于其他两组(p<0.001)。CPR,TNF-α,联合组的IFN-γ和IL-1β水平明显低于其他两组(p<0.001)。治疗后,联合组的VRQOL生活质量评分明显高于其他两组(p<0.05)。
    SH联合普拉洛芬在治疗干眼方面显示出明显的治疗益处,疗效优于单独使用任何一种药物。
    UNASSIGNED: The aim of this study was to investigate the clinical use of sodium hyaluronate (SH) combined with pranoprofen in treating patients with dry eye.
    UNASSIGNED: A total of 117 patients with dry eye who were treated in the Traditional Chinese Medicine Hospital of Kunshan from March 2020 and May 2022 were included. According to the therapy approaches, they were treated with SH (SH group), pranoprofen (pranoprofen group), and SH combined with pranoprofen (joint group) (n = 39).
    UNASSIGNED: The effective rates of dry eye were 79.49%, 74.36% and 94.87% in the SH group, the pranoprofen group and the joint group, respectively (p < 0.05). After treatment, the tear BUT and SIT in the joint group were all prominently increased than those in the other two groups (p < 0.05). The corneal fluorescein staining and dry eye symptom scores in the joint group after treatment were dramatically lower than those in the other two groups (p < 0.001). After treatment, the visual contrast sensitivity (12 c/d, 18 c/d and 24 c/d) in the joint group was markedly higher than those in the other two groups (p < 0.001). The CPR, TNF-α, IFN-γ and IL-1β levels in the joint group were notably decreased than those in other two groups (p < 0.001). After treatment, the VRQOL quality-of-life scores in the joint group were significantly higher than those in the other two groups (p < 0.05).
    UNASSIGNED: SH combined with pranoprofen showed clear therapeutic benefit in treating dry eye, and the curative effect was more favorable than with either medication alone.
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  • 文章类型: Journal Article
    缺乏用于干眼症(DED)临床体征的标准化诊断方法使未来治疗的临床试验变得复杂。本文评估了LissamineGreen(LG)结膜染色的有效性,临床实践和临床试验的稳定和可修改的终点。
    来自两个设计相同的DED临床试验的筛选和随机化前数据产生494名受试者的汇集数据集。纳入是基于报告的症状,Lissaminegreen(LG)con结膜染色,荧光素(Fl)角膜和结膜染色,和Schirmer测试(ST)。基于暴露于受控不良环境(CAE®)的LG染色的可修改性评估结果测量。LG与Fl染色的相关性,LG染色分数和Schirmer测试分数的相对变化,以及LG染色与症状评分的相关性。
    证明了LG结膜染色对环境暴露的可修饰性,鼻LG和FL染色显示最相似的百分比变化。ST评分小于8mm的受试者的鼻LG结膜染色评分明显高于ST大于8mm的受试者。LG染色评分比ST评分更一致(从基线阈值变化25%)。最后,LG染色与许多症状评分之间存在统计学上的显着相关性。
    该评估证明了使用以眼表损伤为中心的临床终点的优越性。LG结膜染色对受控不利环境的可重复性和可修改性,再加上它与症状的显著相关性,将其定位为临床管理和临床试验的示例性临床体征终点。我们的发现主张在临床研究和药物开发中采用LG结膜染色作为主要终点,提供了一种更有效的方法来识别和解决DED领域的眼表损伤。
    UNASSIGNED: The absence of a standardized diagnostic method for clinical signs of Dry Eye Disease (DED) complicates clinical trials for future treatments. This paper evaluated Lissamine Green (LG) conjunctival staining as a valid, stable and modifiable endpoint for both clinical practice and clinical trials.
    UNASSIGNED: Screening and pre-randomization data from two identically designed clinical trials for DED resulted in a pooled dataset of 494 subjects. Inclusion was based on reported symptoms, lissamine green (LG) conjunctival staining, Fluorescein (Fl) corneal and conjunctival staining, and Schirmer\'s Test (ST). Outcome measures were assessed based on the modifiability of LG staining to exposure to a Controlled Adverse Environment (CAE®), correlation of LG to Fl staining, relative variation of LG staining scores and Schirmer test scores, and the correlation of LG staining with symptom scores.
    UNASSIGNED: The modifiability of LG conjunctival staining to environmental exposure was demonstrated, with nasal LG and FL staining displaying the most similar percent change. Nasal LG conjunctival staining scores for subjects with ST scores of less than 8mm were significantly higher than for subjects with ST greater than 8mm. LG staining scores were more consistent (25% change from baseline threshold) than ST scores. Finally, statistically significant correlations were found between LG staining and a number of symptom scores.
    UNASSIGNED: This evaluation demonstrates the superiority of the utilization of a clinical endpoint focused on ocular surface damage. The reproducibility and modifiability of LG conjunctival staining to controlled adverse environment, coupled with its significant correlation with symptoms, positions it as an exemplary clinical sign endpoint for clinical management and in clinical trials. Our findings advocate for the adoption of LG conjunctival staining as a primary endpoint in both clinical research and drug development, offering a more effective means of identifying and addressing ocular surface damage in the realm of DED.
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  • 文章类型: Journal Article
    背景:体内共聚焦显微镜(IVCM)是研究干眼病(DED)的重要工具,提供对眼表单位水平形态变化的见解。这篇综述介绍了房水缺乏型干眼症(AD-DED)与正常眼之间角膜结构的主要差异。
    方法:对PubMed的全面搜索,WebofScience,Embase,和MEDLINE数据库从2000年1月到2023年12月进行。研究的选择过程,以及数据选择和检查,由审查小组的两名成员独立执行。
    结果:该综述显示,与对照组相比,AD-DED病例的角膜表面上皮细胞密度持续下降,但是基底上皮细胞密度的数据相互矛盾。值得注意的是,记录干燥综合征患者角膜细胞的异常高反射率,与蒸发DED和对照组相比,AD-DED受试者的角膜细胞密度显着。研究还发现基底下神经密度下降,弯曲度增加,和神经纤维的碎片。与健康受试者相比,AD-DED患者的树突状细胞密度和树突状细胞树突增加。
    结论:IVCM是增强我们对DED的病理生理机制的理解的有力工具。然而,审查强调了术语标准化的迫切需要,分析,和用于准确解释的单位,这是推进我们对DED知识的关键一步。
    BACKGROUND: In vivo confocal microscopy (IVCM) is a vital tool in studying dry eye disease (DED), providing insights into morphological changes at ocular surface unit levels. This review presents the main differences in corneal structure between aqueous-deficient dry eye disease (AD-DED) and normal eyes.
    METHODS: A comprehensive search of PubMed, Web of Science, Embase, and MEDLINE databases from January 2000 to December 2023 was conducted. The study selection process, as well as data selection and examination, were independently performed by two members of the review team.
    RESULTS: The review reveals a consistent decrease in corneal surface epithelial cell density in AD-DED cases compared to a control group, but conflicting data on basal epithelial cell density. Notably, the abnormal hyperreflectivity of keratocytes in patients with Sjogren\'s syndrome was recorded, and there was a significant keratocyte density in AD-DED subjects compared to evaporative DED and control groups. Studies also found a decrease in sub-basal nerve density, increased tortuosity, and the fragmentation of nerve fibers. Dendritic cell density and dendritic cell dendrites increase in AD-DED patients compared to healthy subjects.
    CONCLUSIONS: IVCM is a powerful tool for enhancing our understanding of the pathophysiological mechanisms underlying DED. However, the review underscores the urgent need to standardize the terminology, analysis, and units used for accurate interpretation, a crucial step in advancing our knowledge of DED.
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  • 文章类型: Journal Article
    蠕形螨眼睑炎,慢性眼睑边缘疾病,是由蠕形螨引起的,人体皮肤和眼睑中最常见的外寄生虫。Lotilaner眼用溶液,0.25%(Xdemvy,TarsusPharmaceuticals),是第一个被批准用于治疗蠕形螨眼睑炎的疗法。这篇叙述性综述描述了洛蒂兰纳眼药水,0.25%,并描述了它的功效,安全,和耐受性。Lotilaner眼用溶液的安全性和有效性,0.25%,在4项2期试验和2项3期试验中评估了蠕形螨眼睑炎的治疗.这些2期和3期临床试验中包含的980名患者的数据显示,具有临床意义的眼睛减少到10支或更少的领口(圆柱形,在睫毛底部发现的蜡状碎片)范围为81%至93%。通过显微镜观察脱毛睫毛证实的螨根除率为52%至78%。这些临床研究均未报告严重的治疗相关不良事件。在3期试验中,高达92%的接受lotilaner眼药水的患者发现它是中性的,非常舒适。鉴于积极的安全性和有效性结果,该药物可能成为治疗蠕形螨的标准护理。
    Demodex blepharitis, a chronic lid margin disease, is caused by an infestation of Demodex mites, the most common ectoparasites in human skin and eyelids. Lotilaner ophthalmic solution, 0.25% (Xdemvy, Tarsus Pharmaceuticals), is the first therapy approved to treat Demodex blepharitis. This narrative review characterizes lotilaner ophthalmic solution, 0.25%, and describes its efficacy, safety, and tolerability. The safety and efficacy of lotilaner ophthalmic solution, 0.25%, for treating Demodex blepharitis was evaluated in four phase 2 and two phase 3 trials. The data of 980 patients included in these phase 2 and 3 clinical trials revealed that the proportion of eyes with a clinically meaningful reduction to 10 or fewer collarettes (the cylindrical, waxy debris found at the base of the eyelashes) ranged from 81 to 93%. The mite eradication rate confirmed by a microscopy of epilated lashes ranged from 52 to 78%. No serious treatment-related adverse events were reported in any of these clinical studies. As high as 92% of the patients receiving lotilaner eyedrops in the phase 3 trials found it to be neutral to very comfortable. Given the positive safety and efficacy outcomes, the drug is likely to become the standard of care in the treatment of Demodex blepharitis.
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  • 文章类型: Case Reports
    干燥综合征是一种全身性免疫疾病,表现在眼睛和嘴巴干涩。文献中很少提到没有眼部表现的原发性干燥综合征。
    作者报告了一例48岁女性,主诉口腔干燥和吞咽困难6个月。身体检查显示嘴唇干燥伴有角状唇炎,红斑的舌头,颊粘膜干燥,有多个龋齿。两侧的Stenson和Wharton的管道中唾液流量很少。她的眼科检查正常。实验室检查显示白细胞减少症,贫血,血小板减少症,升高的C反应蛋白水平和红细胞沉降率,强阳性的抗核抗体,反SS-A,反SS-,和风湿因子。超声检查显示两个腮腺的高回声结节。唾液腺活检示淋巴细胞浸润。诊断为原发性干燥综合征。她用毛果芸香碱5mg治疗3个月,维生素C,和用于口腔干燥的人工唾液。她正在接受持续的随访,缓解了50-60%,没有任何系统性并发症。
    Sjögren综合征影响外分泌腺,导致口干和眼睛,会引起全身症状,包括疲劳和关节痛。报告病例中眼部受累的发生率为86.1%,而我们的病人没有任何眼部受累,这是一种罕见的情况。鉴别诊断包括糖尿病,甲状腺功能减退,慢性病毒学感染,和一些引起干燥的药物,这是非常排除的。干燥症状的治疗涉及人工泪液和刺激唾液流动的药物,而全身性疾病的治疗包括皮质类固醇,和各种DMARD,利妥昔单抗。这种疾病增加了B细胞非霍奇金淋巴瘤发展的相对风险。因此,需要对病人进行监测,尤其是在存在危险因素的情况下。
    早期诊断这种疾病非常重要,使用各种诊断标准。
    UNASSIGNED: Sjögren\'s Syndrome is a systemic immune disorder, manifested in dry eyes and mouth. Primary Sjögren\'s syndrome without ocular manifestation is seldom mentioned in the literature.
    UNASSIGNED: The authors report a case of a 48-year-old female who complained of dryness of mouth and dysphagia for 6 months. Physical examinations showed dry lips with angular cheilitis, an erythematous tongue, and dry buccal mucosa, with multiple carious teeth. The salivary flow was scanty from the Stenson\'s and Wharton\'s ducts on both sides. Her ophthalmological examination was normal. Laboratory tests revealed leukopenia, anemia, thrombocytopenia, elevated levels of C-reactive protein and erythrocyte sedimentation rate, a strongly positive antinuclear antibody, anti-SS-A, anti-SS-, and rheumatic factor. Hyperechoic nodules in both parotids were shown by Ultrasonography. Salivary gland biopsy showed lymphocytic infiltration. Diagnosis of primary Sjögren\'s syndrome was made. She was treated with Pilocarpine 5 mg for 3 months, Vitamin C, and artificial saliva for oral dryness. She is under continuous follow-up with 50-60% relief, without any systemic complications.
    UNASSIGNED: Sjögren\'s Syndrome affects the exocrine glands causing dry mouth and eyes, and can cause systemic symptoms, including fatigue and joint pain. The incidence of ocular involvement among the reported cases is 86.1%, whereas our patient did not have any ocular involvement, and this represents a rare condition. The differential diagnosis included diabetes mellitus, hypothyroidism, chronic virology infection, and some medications that cause dryness, which were very much ruled out. Treatment of sicca symptoms involves artificial tears and medications that stimulate saliva flow while treatment of systemic disease includes corticosteroids, and various DMARDs, Rituximab. this disease has an increased relative risk for the development of B-cell non-Hodgkin\'s lymphoma. Therefore, patients need to be monitored, especially in the presence of risk factors.
    UNASSIGNED: It is very important to diagnose this disorder early, using the various diagnostic criteria.
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  • 文章类型: Journal Article
    睑板腺(MG)功能障碍和青光眼是非常普遍的眼部疾病,严重影响患者的生活质量。越来越多的临床和实验研究报道了使用局部滴眼剂降低眼内压与MG功能障碍的发展或恶化之间的关联。调查青光眼滴眼液对MG诊断参数的影响的研究显示出不同的结果,特别是关于MG和泪膜不稳定性的形态和功能。在这里,通过系统评价和荟萃分析,我们证实了在抗青光眼滴眼液治疗的患者中,与MG相关的形态学和功能变量发生更大变化的发现.
    Meibomian gland (MG) dysfunction and glaucoma are very prevalent ocular conditions that significantly impact patients\' quality of life. A growing number of clinical and experimental studies have reported an association between the use of topical eye drops to reduce intraocular pressure and the development or exacerbation of MG dysfunction. Studies investigating the impact of glaucoma eyedrops on MG diagnostic parameters have shown variable results, particularly regarding the morphology and function of MG and tear film instability. Herein, we corroborated the findings of greater changes in morphological and functional variables related to MG in patients treated with antiglaucoma eye drops through a systematic review and meta-analysis.
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  • 文章类型: Journal Article
    目的:评估使用OculusKeratograph5M(K5M)和SBMSistemiIDRA(IDRA)进行干眼测量的可重复性和一致性。
    方法:共纳入108名参与者,评估108只眼。使用K5M和IDRA(随机分配顺序)测量撕裂半月板高度(TMH)以及第一和平均非侵入性破裂时间(NIBUT)。TMH是使用内置卡尺工具测量的,而NIBUT是通过仪器的自动算法计算的。
    结果:BlandAltman图分析显示,TMH的两种仪器之间具有良好的一致性(95%协议限制(LoA),-0.17至0.16),但不是第一个NIBUT(95%LoA,-8.13至14.79)和平均NIBUT(95%LoA,-7.89至10.32)。使用IDRA测量的首次和平均NIBUT的值明显短于K5M(差异=中位数(IQR)-2.75(-6.48--0.28)s,p<0.001,差异=中位数(IQR)-1.65(-3.97-1.89)s,p分别=0.008)。用K5M测量的TMH(p=0.037)和NIBUT平均值(p=0.033),以及IDRA测得的TMH(p=0.040),在三个测量时间内表现出不稳定的测量结果。其余参数在三次重复测量时表现出稳定性。
    结论:NIBUT测量值在IDRA和K5M之间不可互换,而TMH在两种仪器之间差异不大。使用不同的眼表分析仪时,请务必谨慎,以最大程度地减少比较多个测量结果时的误差。
    OBJECTIVE: To evaluate the repeatability and agreement in dry eye measurements using Oculus Keratograph 5M (K5M) and SBM Sistemi IDRA (IDRA).
    METHODS: A total of 108 participants were enrolled and 108 eyes were evaluated. Tear meniscus height (TMH) and first and average non-invasive break-up time (NIBUT) were measured using the K5M and IDRA (order randomly assigned). TMH was measured using the built-in caliper tool while NIBUT was computed by the automatic algorithm of the instruments.
    RESULTS: The Bland Altman plots analysis showed a good agreement between the two instruments for TMH (95 % Limits of Agreement (LoA), -0.17 to 0.16), but not the first NIBUT (95 % LoA, -8.13 to 14.79) and average NIBUT (95 % LoA, -7.89 to 10.32). The values of the first and average NIBUT measured using IDRA were significantly shorter than in K5M (difference = median (IQR) -2.75 (-6.48- -0.28)s, p < 0.001 and difference = median (IQR) -1.65 (-3.97-1.89)s, p = 0.008 respectively). The TMH (p = 0.037) and NIBUT average (p = 0.033) measured by K5M, as well as the TMH (p = 0.040) measured by IDRA, exhibited unstable measurements across the three measurement times. The remaining parameters exhibited stability with three repeated measurements.
    CONCLUSIONS: The NIBUT measurements are not interchangeable between IDRA and K5M, while the TMH was little difference between the two instruments. It is important to exercise caution when using different ocular surface analyzers to minimize errors in comparing multiple measurements.
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  • 文章类型: Journal Article
    背景:低水平光疗(LLLT)或光生物调节,红光对眼睛的应用,用于治疗干眼症。有限的研究已经调查了LLLT作为独立治疗的功效。该研究旨在评估LLLT对干眼的体征和症状的影响。
    方法:招募轻度至中度干眼症的参与者参加了这项3次访视研究。访问间隔7(±3)天,并且所有参与者在每次访问时接受633nmLLLT(眼光®)15分钟。临床措施包括首次和平均非侵入性角膜造影撕裂破裂时间(NIKBUT),撕裂弯月面高度(TMH),睑板腺(MG)上下眼睑的损失,眼表疾病指数(OSDI)评分,泪膜脂质层厚度,美布质量评分,Schirmer\'stest,在治疗前后从参与者的右眼测量角膜荧光素染色和外部上眼睑(EUL)和外部下眼睑(ELL)的眼睑温度。
    结果:30名参与者(平均[SD]年龄:31.1[9.5]岁)完成了研究。用LLLT治疗导致第一和平均NIKBUT的显着差异,TMH,泪膜脂质层厚度,OSDI得分,Schirmer\'stest,眼睑质量评分和眼睑温度随时间变化(均p<0.05)。与基线相比,TMH,泪膜脂质层厚度和眼睑温度显着增加0.06mm(95%CI:0.01-0.11),12.9nm(95%CI:1.18-24.55),和7.0°C,分别,对于EUL(95%CI:6.17-7.84)和ELL(95%CI:6.17-7.73)。OSDI评分和Schirmer检验的降低分别为10.2(95%CI:-15.15至-5.26)和4.4mm(95%CI:-7.31至-1.42;所有p<0.05)。LLLT后角膜荧光素染色和MG丢失没有显着差异。
    结论:低水平光疗治疗可在治疗早期显著改善干眼的体征和症状,提示其对干眼管理的功效。
    BACKGROUND: Low-level light therapy (LLLT) or photobiomodulation, the application of red light to the eye, is used for the treatment of dry eye. Limited studies have investigated the efficacy of LLLT as a stand-alone treatment. The investigation aimed to evaluate the effect of LLLT on signs and symptoms of dry eye.
    METHODS: Participants with mild to moderate dry eye were recruited for this three-visit study. Visits were 7 (±3) days apart and all participants received 633 nm LLLT (eye-light®) for 15 min at each visit. Clinical measures including first and average non-invasive keratograph tear break-up time (NIKBUT), tear meniscus height (TMH), meibomian gland (MG) loss for upper and lower eyelids, ocular surface disease index (OSDI) score, tear film lipid layer thickness, meibum quality score, Schirmer\'s test, corneal fluorescein staining and eyelid temperature for external upper (EUL) and external lower (ELL) eyelids were measured from the right eye of participants before and after treatment.
    RESULTS: Thirty participants (mean [SD] age: 31.1 [9.5] years) completed the study. Treatment with LLLT resulted in significant differences in first and average NIKBUT, TMH, tear film lipid layer thickness, OSDI score, Schirmer\'s test, meibum quality score and eyelid temperature over time (all p < 0.05). Compared to baseline, TMH, tear film lipid layer thickness and eyelid temperature significantly increased by 0.06 mm (95% CI: 0.01-0.11), 12.9 nm (95% CI: 1.18-24.55), and 7.0°C, respectively, for both EUL (95% CI: 6.17-7.84) and ELL (95% CI: 6.17-7.73). The respective decrease in the OSDI score and Schirmer\'s test was 10.2 (95% CI: -15.15 to -5.26) and 4.4 mm (95% CI: -7.31 to -1.42; all p < 0.05). There was no significant difference in corneal fluorescein staining and MG loss after LLLT.
    CONCLUSIONS: Low-level light therapy treatment significantly improved signs and symptoms of dry eye in the early phases of treatment, suggesting its efficacy for dry eye management.
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  • 文章类型: Journal Article
    目的:这项临床研究比较了EyestilPlus®(SFI)和VismedMulti®(TRBChemedica)在减轻中度至重度干眼症(DED)患者角膜炎病变方面的性能和安全性。
    方法:这是一个随机的,双盲,多中心调查。96名患有中度至重度DED的成年人(>18岁)每天接受6次EyestilPlus®(N=48)或VismedMulti®(n=48),为期3个月。1个月后的主要客观临床表现为整体角膜和结膜染色评分。次要目标是3个月后的临床表现,泪膜稳定性(泪液破裂时间(TBUT),泪液产生(Schirmer试验),患者报告结果(PRO),调查员满意度,和安全。
    结果:96名参与者被随机分配接受临床研究治疗,其中82.3%为女性,平均年龄为65.8岁。在1个月时证明了EyestilPlus®对中度至重度DED的非劣效性。任何研究目标均未发现统计学差异:1个月和3个月时整体角膜和结膜染色评分的变化(p值分别为0.506和0.661),TBUT试验在1个月和3个月时的变化(p值=0.538和0.302);Schirmer试验在3个月时的变化(p值=0.540)。Pro也没有变化。研究者对这两种产品的满意度都很高。16.6%的参与者出现不良事件。
    结论:这项临床研究表明,在中度至重度DED人群中,与VismedMulti®相比,EyestilPlus®在性能和安全性方面具有非劣效性。
    OBJECTIVE: This clinical investigation compared the performance and safety of Eyestil Plus® (SIFI) and Vismed Multi® (TRB Chemedica) for reducing keratitis lesions in moderate-to-severe dry eye disease (DED) patients.
    METHODS: This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (N = 48) or Vismed Multi® (n = 48) 6 times daily for 3 months. The primary objective clinical performance after 1 month as global corneal and conjunctival staining scores. The secondary objectives were clinical performance after 3 months, tear film stability (tear break up time (TBUT), tear production (Schirmer test), patient-reported outcomes (PROs), investigator satisfaction, and safety.
    RESULTS: 96 participants were randomised to receive the clinical investigations\' treatments, 82.3% of them were female and their mean age was 65.8 years. The non-inferiority of Eyestil Plus® for moderate-to-severe DED was demonstrated at 1 month. No statistical difference was found for any of the study\'s objectives: change at 1 and 3 months of the global corneal and conjunctival staining score (p-value = 0.506 and 0.661, respectively), change at 1 and 3 months (p-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (p-value = 0.540). There were no changes for PROs either. Investigator satisfaction was high for both products. 16.6% of the participants experienced adverse events.
    CONCLUSIONS: This clinical investigation showed the non-inferiority of Eyestil Plus® compared to Vismed Multi® regarding performance and safety in a moderate-to-severe DED population.
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