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Association of the serum chemerin level with the development of diabetic retinopathy in patients with type 1 diabetes mellitus. 1型糖尿病患者血清趋化素水平与糖尿病视网膜病变的关系
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1461
Ahmed Gomaa Elmahdy, Mohamed Mohamed-Aly Ibrahim, Omar Hassan Salama, Hossam Eldin Abdelmonem Ziada, Mahmoud Mohammed Ali, Ghada F Elmohaseb, Eman Mi Youssef, Eman Saad Bayoumy, Marwa Ahmed Bayomy, Sanaa Ahmed Mohamed

Background: In patients with type 2 diabetes mellitus, the development of diabetic retinopathy (DR) correlates positively with elevated serum chemerin levels. This study was aimed at investigating the probable association between the serum chemerin level and the development of DR in patients with type 1 diabetes mellitus (T1DM).

Methods: In this cross-sectional study, we included Egyptians and classified them into four groups: group 1, including healthy individuals; group 2, including patients with T1DM without DR; group 3, including patients with T1DM with non-proliferative DR (NPDR); and group 4, including patients with T1DM with proliferative DR (PDR). The assessment included best-corrected distance visual acuity assessment, slit-lamp biomicroscopy, funduscopy, fundus fluorescein angiography, and macular ocular coherence tomography. Fasting blood samples were obtained from all participants to measure serum chemerin, glycated hemoglobin (HbA1c), total cholesterol, triglyceride, and creatinine levels. Serum chemerin levels were compared among the groups, and their correlations with age, duration of diabetes, HbA1c, total cholesterol, triglyceride, and creatinine levels were analyzed.

Results: We recruited 209 participants, including 46 healthy individuals in group 1, 52 patients (T1DM and no DR) in group 2, 61 patients (T1DM and NPDR) in group 3, and 50 patients (T1DM and PDR) in group 4, with comparable mean ages and sex ratios among groups. The diabetes duration, body mass index, HbA1c, total cholesterol, triglyceride, and serum chemerin levels differed significantly among the groups (all P < 0.001), whereas the creatinine level did not (P > 0.05). The serum chemerin level was significantly higher in group 4 than in groups 3 and 2, in group 3 than in group 2, and in groups 3 and 4 than in group 1 (all P < 0.001). However, it was comparable between groups 1 and 2 (P > 0.05). It correlated with the duration of T1DM and HbA1c, total cholesterol, triglyceride, and creatinine levels but not with age.

Conclusions: Patients with T1DM with DR showed higher serum chemerin levels than those with T1DM without DR or healthy individuals. Serum chemerin levels were higher in those with PDR than in those with NPDR. Thus, serum chemerin levels are a potential biomarker of the development and severity of DR in patients with T1DM. Nevertheless, future diagnostic accuracy studies are required to confirm these potential applications.

背景:在2型糖尿病患者中,糖尿病视网膜病变(DR)的发展与血清趋化素水平升高呈正相关。本研究旨在探讨1型糖尿病(T1DM)患者血清趋化素水平与DR发生之间的可能关系。方法:在本横断面研究中,我们纳入埃及人并将其分为四组:1组,包括健康个体;2组,包括无DR的T1DM患者;3组,包括T1DM合并非增殖性DR (NPDR)患者;第4组,包括合并增生性DR (PDR)的T1DM患者。评估包括最佳矫正距离视力评估、裂隙灯生物显微检查、眼底镜检查、眼底荧光素血管造影和黄斑眼相干断层扫描。所有参与者的空腹血样用于测定血清趋化素、糖化血红蛋白(HbA1c)、总胆固醇、甘油三酯和肌酐水平。比较各组血清趋化素水平,并分析其与年龄、糖尿病病程、HbA1c、总胆固醇、甘油三酯和肌酐水平的相关性。结果:我们招募了209名参与者,其中第1组46名健康个体,第2组52名患者(T1DM和无DR),第3组61名患者(T1DM和NPDR),第4组50名患者(T1DM和PDR),各组之间的平均年龄和性别比例相当。糖尿病病程、体重指数、HbA1c、总胆固醇、甘油三酯和血清趋化素水平组间差异显著(均P < 0.001),而肌酐水平组间差异无统计学意义(P > 0.05)。血清趋化素水平4组显著高于3、2组,3组显著高于2组,3、4组显著高于1组(均P < 0.001)。但1组和2组间具有可比性(P > 0.05)。它与T1DM和HbA1c持续时间、总胆固醇、甘油三酯和肌酐水平相关,但与年龄无关。结论:合并DR的T1DM患者血清趋化素水平高于未合并DR的T1DM患者和健康人群。PDR患者血清趋化素水平高于NPDR患者。因此,血清趋化素水平是T1DM患者DR发展和严重程度的潜在生物标志物。然而,未来的诊断准确性研究需要确认这些潜在的应用。
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引用次数: 0
Indications and outcomes of pediatric penetrating keratoplasty: A retrospective observational study. 儿童穿透性角膜移植术的适应症和结果:一项回顾性观察研究。
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1442
Areen Abukahel, Ahmad S Aldiwanie, Saif Aldeen AlRyalat, Almutez M Gharaibeh

Background: Pediatric corneal transplantation can be indicated in congenital and acquired conditions. Challenges include preoperative evaluation, multiple intraoperative obstacles, and postoperative problems in follow-up and management. This study was aimed at identifying the indications and clinical outcomes of pediatric penetrating keratoplasty (PKP) in Jordan.

Methods: This retrospective cohort study was conducted in Amman, Jordan. Using the hospital's electronic database, all medical records of patients aged < 18 years who underwent PKP between January 2004 and October 2019 were reviewed. Preoperative evaluations included best-corrected distance visual acuity (BCDVA) and anterior and posterior segment examinations. Postoperative complications, BCDVA, and graft survival were examined 1 year postoperatively.

Results: A total of 149 cases of pediatric PKP were performed on 141 eyes of 118 patients with an age mean ± standard deviation (SD) of 11.44 ± 4.97 years at the time of surgery. Acquired non-traumatic corneal pathologies accounted for 65.8% of indications for PKP. The most frequent indication was advanced keratoconus (55.7%). Preoperative and 1-year postoperative BCDVAs significantly differed (P < 0.001), with 111 (74.5%) patients showing improved BCDVA, 12 (8.05%) patients showing worsened BCDVA, and 26 (17.45%) patients showing no change in BCDVA. The overall 1-year graft survival rate was 80.54%.

Conclusions: This was the largest study in Jordan involving pediatric patients who underwent PKP for various indications, showing a significant improvement in BCDVA, with a high survival rate at 1 year. Future studies with longer follow-up periods could provide stronger evidence for surgical outcomes and graft survival. Further, the option of lamellar keratoplasty in the pediatric age group should be assessed.

背景:儿童角膜移植可指先天性和后天性疾病。挑战包括术前评估,术中多种障碍,术后随访和管理问题。本研究旨在确定约旦儿童穿透性角膜移植术(PKP)的适应症和临床结果。方法:本回顾性队列研究在约旦安曼进行。利用医院的电子数据库,回顾了2004年1月至2019年10月期间接受PKP治疗的所有年龄< 18岁患者的医疗记录。术前评估包括最佳矫正距离视力(BCDVA)和前后节检查。术后1年观察术后并发症、BCDVA和移植物存活率。结果:共对118例患者141只眼进行了149例小儿PKP手术,手术年龄平均±标准差(SD)为11.44±4.97岁。获得性非创伤性角膜病变占PKP适应症的65.8%。最常见的适应症是晚期圆锥角膜(55.7%)。术前和术后1年BCDVA差异有统计学意义(P < 0.001), 111例(74.5%)患者BCDVA改善,12例(8.05%)患者BCDVA恶化,26例(17.45%)患者BCDVA无变化。移植1年总生存率为80.54%。结论:这是约旦最大的一项针对各种适应症接受PKP的儿科患者的研究,显示BCDVA有显著改善,1年生存率高。未来更长随访期的研究可以提供更有力的手术结果和移植物存活的证据。此外,应评估儿童年龄组板层角膜移植术的选择。
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引用次数: 0
A hypothetical therapeutic effect of light peripheral panretinal photocoagulation in neovascular age-related macular degeneration. 光周围全视网膜光凝治疗新生血管性年龄相关性黄斑变性的假想效果。
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1457
Ahmad M Mansour, Koushik Tripathy, Maurizio Battaglia Parodi

Background: Vascular endothelial growth factor (VEGF) is a significant modulator of ocular angiogenesis, including that of neovascular age-related macular degeneration (nAMD). Intravitreal injection of anti-VEGF is the benchmark treatment for most retinal vascular diseases, including nAMD, diabetic maculopathy, and macular edema secondary to retinal venous occlusion. Anti-VEGF treatment is a high-frequency, time-consuming, non-cost-effective therapy, especially in countries and regions with limited resources. This treatment is easily restricted, and in practice, maintaining long-term periodic care is challenging for patients.

Hypothesis: Light peripheral panretinal photocoagulation (PPRP) is applied in a mild form (barely visible mild light gray mark) anterior to the equator so as not to jeopardize the visual field. PPRP lessens the ischemia that causes neovascularization and decreases the metabolic demand in the peripheral retina. PPRP reduces serum angiopoietin-2 and VEGF levels in patients with type 2 diabetes mellitus with proliferative diabetic retinopathy. We propose using light PPRP to suppress VEGF secretion, aiming to attenuate the VEGF drive and halt choroidal neovascular growth in eyes with nAMD. Our regimen is based on two concepts: first, nAMD is a diffuse or generalized disease that affects the posterior segment; and second, PPRP is very effective in regressing diabetic retinopathy. PPRP has reportedly been successful in cases of macular edema (diabetic or following venous occlusion) resistant to VEGF antagonists. Light PPRP may be used as prophylaxis, adjunctive treatment, or monotherapy in nAMD when intravitreal injections of VEGF antagonists are not feasible.

Conclusions: The established light PPRP therapy could be promising as a one-time, cost-effective therapy or prophylaxis in patients with nAMD or at high risk. This proposed modality could be suitable for patients who have injection phobia or prefer a one-time affordable therapy to the long-term monthly visits to retinologists. Future trials are necessary to verify the safety and efficacy of this proposed treatment modality in selected patients with nAMD.

背景:血管内皮生长因子(VEGF)是眼部血管生成的重要调节剂,包括新生血管性年龄相关性黄斑变性(nAMD)。玻璃体内注射抗vegf是大多数视网膜血管疾病的基准治疗方法,包括nAMD、糖尿病黄斑病变和继发于视网膜静脉闭塞的黄斑水肿。抗vegf治疗是一种高频、耗时、不划算的治疗方法,特别是在资源有限的国家和地区。这种治疗很容易受到限制,而且在实践中,维持长期的周期性护理对患者来说是具有挑战性的。假设:光周围全视网膜光凝(PPRP)在赤道前以轻度形式应用(几乎不可见轻度浅灰色标记),以免危及视野。PPRP可减轻引起新生血管形成的缺血,并降低视网膜周围的代谢需求。PPRP降低2型糖尿病合并增殖性糖尿病视网膜病变患者血清血管生成素-2和VEGF水平。我们建议使用轻型PPRP抑制VEGF的分泌,旨在减弱VEGF的驱动,阻止nAMD眼脉络膜新生血管的生长。我们的治疗方案基于两个概念:首先,nAMD是一种影响后段的弥漫性或广泛性疾病;第二,PPRP对糖尿病视网膜病变的消退非常有效。据报道,PPRP在黄斑水肿(糖尿病或静脉闭塞)抵抗VEGF拮抗剂的情况下是成功的。当玻璃体内注射VEGF拮抗剂不可行时,轻度PPRP可作为nAMD的预防、辅助治疗或单药治疗。结论:已建立的轻度PPRP治疗可能是一种有希望的一次性,具有成本效益的治疗或预防nAMD患者或高风险。这种建议的方式可能适合有注射恐惧症的患者,或者更喜欢一次性负担得起的治疗,而不是长期每月去看视网膜医生。未来的试验需要验证这种建议的治疗方式在选定的nAMD患者中的安全性和有效性。
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引用次数: 0
rs10737680 polymorphism in complement factor H and neovascular age-related macular degeneration in Yogyakarta, Indonesia. 补体因子H和新血管性年龄相关性黄斑变性的rs10737680多态性
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1448
Talenta Sigalingging, Ayudha Bahana Ilham Perdamaian, Dewi Fathin Romdhoniyyah, Muhammad Eko Prayogo, Firman Setya Wardhana, Tri Wahyu Widayanti, Muhammad Bayu Sasongko, Angela Nurini Agni, Chio Oka, Supanji Supanji

Background: Neovascular age-related macular degeneration (nAMD) is one of the main causes of blindness in developed countries. Complement factor H (CFH) is one of the genes involved in the pathogenesis of nAMD. This study investigated the rs10737680 polymorphism in CFH and its conferred susceptibility to nAMD in Yogyakarta, Indonesia.

Methods: This case-control hospital-based study recruited participants consisting of 96 patients with nAMD and 101 controls without nAMD from the Eye Polyclinic of Sardjito Hospital, YAP Eye Hospital, and Hardjolukito Hospital Yogyakarta. nAMD was diagnosed when fundus examination, fundus photographs, and optical coherence tomography revealed hard or soft drusen in the macular area measuring > 63 µm that appeared below the retinal pigment epithelium, with or without macular hypo- or hyperpigmentation, and was accompanied by choroidal neovascularization. Genomic DNA was extracted using a commercial DNA isolation kit. The restriction fragment length polymorphism technique was used to identify the rs10737680 polymorphism in CFH.

Results: The mean (standard deviation [SD]) age of the nAMD group was not homogeneous with that of the control group (P < 0.05); 65.41 (9.74) years versus 68.24 (7.82) years. The number of patients with hypertension in the nAMD group was significantly higher than in the control group (P < 0.05). In the nAMD group, the genotype distribution indicated homozygous risk allele in 34.38%, heterozygous risk allele in 57.29%, and homozygous non-risk allele in 8.33%. In the control group, the genotype distribution indicated homozygous risk allele in 21.78%, heterozygous risk allele in 36.63%, and homozygous non-risk allele in 41.58%. Statistical analysis between the two study groups according to homozygous risk allele genotype (odds ratio [OR], 7.87; 95% confidence interval [CI], 2.88-22.79) and heterozygous genotype (OR, 7.80; 95% CI, 3.11-21.19) showed a significant difference (both P < 0.01).

Conclusions: Homozygous risk allele was less frequent than heterogeneous risk allele in patients with nAMD; however, both increased the risk for nAMD. Although the homozygous or heterozygous risk-alleles were detected in most patients, yet other important genetic or environmental factors could be involved in the pathogenesis of nAMD. Overall, we found a significant association between rs10737680 polymorphism in CFH and the susceptibility to nAMD in Yogyakarta, Indonesia; however, future studies are needed to fully delineate the mechanism.

背景:新生血管性年龄相关性黄斑变性(nAMD)是发达国家致盲的主要原因之一。补体因子H (CFH)是参与nAMD发病机制的基因之一。本研究调查了印度尼西亚日惹地区CFH的rs10737680多态性及其对nAMD的易感性。方法:这项以医院为基础的病例对照研究招募了来自日惹Sardjito医院、YAP眼科医院和Hardjolukito医院眼科综合诊所的96名nAMD患者和101名非nAMD对照组。眼底检查、眼底照片、光学相干断层扫描显示视网膜色素上皮以下出现> 63µm的黄斑区硬或软结节,伴或不伴黄斑色素沉着或色素沉着,并伴有脉络膜新生血管形成。使用商用DNA分离试剂盒提取基因组DNA。采用限制性片段长度多态性技术对CFH中的rs10737680基因多态性进行了鉴定。结果:nAMD组患者的平均(标准差[SD])年龄与对照组差异无统计学意义(P < 0.05);65.41(9.74)岁vs 68.24(7.82)岁。nAMD组高血压患者人数显著高于对照组(P < 0.05)。nAMD组基因型分布为纯合子风险等位基因占34.38%,杂合子风险等位基因占57.29%,纯合子非风险等位基因占8.33%。对照组基因型分布为纯合子风险等位基因占21.78%,杂合子风险等位基因占36.63%,纯合子非风险等位基因占41.58%。根据纯合子风险等位基因型对两组患者进行统计学分析(优势比[OR], 7.87;95%可信区间[CI], 2.88-22.79)和杂合子基因型(OR, 7.80;95% CI(3.11 ~ 21.19),差异均有统计学意义(P < 0.01)。结论:纯合子风险等位基因在nAMD患者中的发生率低于异质性风险等位基因;然而,两者都增加了患nAMD的风险。虽然在大多数患者中检测到纯合子或杂合子风险等位基因,但其他重要的遗传或环境因素可能参与了nAMD的发病机制。总体而言,我们发现在印度尼西亚日惹地区CFH中rs10737680多态性与nAMD易感性之间存在显著关联;然而,未来的研究需要充分描述其机制。
{"title":"rs10737680 polymorphism in complement factor H and neovascular age-related macular degeneration in Yogyakarta, Indonesia.","authors":"Talenta Sigalingging,&nbsp;Ayudha Bahana Ilham Perdamaian,&nbsp;Dewi Fathin Romdhoniyyah,&nbsp;Muhammad Eko Prayogo,&nbsp;Firman Setya Wardhana,&nbsp;Tri Wahyu Widayanti,&nbsp;Muhammad Bayu Sasongko,&nbsp;Angela Nurini Agni,&nbsp;Chio Oka,&nbsp;Supanji Supanji","doi":"10.51329/mehdiophthal1448","DOIUrl":"https://doi.org/10.51329/mehdiophthal1448","url":null,"abstract":"<p><strong>Background: </strong>Neovascular age-related macular degeneration (nAMD) is one of the main causes of blindness in developed countries. <i>Complement factor H (CFH)</i> is one of the genes involved in the pathogenesis of nAMD. This study investigated the rs10737680 polymorphism in <i>CFH</i> and its conferred susceptibility to nAMD in Yogyakarta, Indonesia.</p><p><strong>Methods: </strong>This case-control hospital-based study recruited participants consisting of 96 patients with nAMD and 101 controls without nAMD from the Eye Polyclinic of Sardjito Hospital, YAP Eye Hospital, and Hardjolukito Hospital Yogyakarta. nAMD was diagnosed when fundus examination, fundus photographs, and optical coherence tomography revealed hard or soft drusen in the macular area measuring > 63 µm that appeared below the retinal pigment epithelium, with or without macular hypo- or hyperpigmentation, and was accompanied by choroidal neovascularization. Genomic DNA was extracted using a commercial DNA isolation kit. The restriction fragment length polymorphism technique was used to identify the rs10737680 polymorphism in <i>CFH</i>.</p><p><strong>Results: </strong>The mean (standard deviation [SD]) age of the nAMD group was not homogeneous with that of the control group (<i>P</i> < 0.05); 65.41 (9.74) years versus 68.24 (7.82) years. The number of patients with hypertension in the nAMD group was significantly higher than in the control group (<i>P</i> < 0.05). In the nAMD group, the genotype distribution indicated homozygous risk allele in 34.38%, heterozygous risk allele in 57.29%, and homozygous non-risk allele in 8.33%. In the control group, the genotype distribution indicated homozygous risk allele in 21.78%, heterozygous risk allele in 36.63%, and homozygous non-risk allele in 41.58%. Statistical analysis between the two study groups according to homozygous risk allele genotype (odds ratio [OR], 7.87; 95% confidence interval [CI], 2.88-22.79) and heterozygous genotype (OR, 7.80; 95% CI, 3.11-21.19) showed a significant difference (both <i>P</i> < 0.01).</p><p><strong>Conclusions: </strong>Homozygous risk allele was less frequent than heterogeneous risk allele in patients with nAMD; however, both increased the risk for nAMD. Although the homozygous or heterozygous risk-alleles were detected in most patients, yet other important genetic or environmental factors could be involved in the pathogenesis of nAMD. Overall, we found a significant association between rs10737680 polymorphism in <i>CFH</i> and the susceptibility to nAMD in Yogyakarta, Indonesia; however, future studies are needed to fully delineate the mechanism.</p>","PeriodicalId":36524,"journal":{"name":"Medical Hypothesis, Discovery, and Innovation in Ophthalmology","volume":"11 2","pages":"71-76"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/12/c9/mehdiophth-11-071.PMC10445304.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10467190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optic nerve head perfusion changes in eyes with proliferative diabetic retinopathy treated with intravitreal ranibizumab or photocoagulation: a randomized controlled trial. 玻璃体内雷尼珠单抗或光凝治疗增殖性糖尿病视网膜病变患者眼部视神经头灌注改变:一项随机对照试验
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1459
Ahmed Magdy Raffat Helmy, Mohammad Ahmad Rashad, Hesham Mohamed Gharieb, Wael Adel Gomaa, Rania Gamal Eldin Zaki

Background: Proliferative diabetic retinopathy (PDR) is a serious sight-threatening disease, and half of the patients with high-risk PDR can develop legal blindness within 5 years, if left untreated. This study was aimed at comparing panretinal photocoagulation (PRP) and intravitreal ranibizumab injections in terms of radial peripapillary capillary (RPC) density on optical coherence tomography angiography (OCTA) in patients with treatment-naive PDR.

Methods: This open-label, prospective, randomized clinical trial included 50 patients with treatment-naive PDR with optic disc neovascularization and randomized them into two groups: group 1, with patients undergoing two sessions of PRP 2 weeks apart, and group 2, with patients received three intravitreal ranibizumab injections (0.5 mg) 1 month apart for 3 consecutive months. Patients underwent a full ophthalmological examination, including best-corrected distance visual acuity (BCDVA) measurement in the logarithm of minimal angle of resolution (logMAR) notation and OCTA before intervention and monthly after the last laser session or the first intravitreal ranibizumab injection for 3 months of follow-up. Visual field (VF) was tested at the beginning and end of 3 months.

Results: Forty-two (84%) eyes completed the 3-month follow-up, including 22 eyes in the PRP group (88%) and 20 (80%) eyes in the ranibizumab group. The two groups were comparable in terms of demographic characteristics, diabetes duration, baseline BCDVA, glycated hemoglobin level, OCTA parameters, VF indices, and intraocular pressure (all P > 0.05). The RPC density change from baseline to the 3-month follow-up was significantly lower in the PRP group than in the ranibizumab group (mean difference in RPC density change: - 3.61%; 95% confidence interval: - 5.57% to - 1.60%; P = 0.001). The median (interquartile range) logMAR change from baseline to the 3-month follow-up (0.0 [0.2]) was significantly higher in the PRP group than in the ranibizumab group (- 0.15 [0.3]; P < 0.05). The median changes in central foveal thickness from baseline to the 3-month follow-up differed significantly between the two groups (P = 0.001).

Conclusions: In eyes with PDR and neovascularization of the disc RPC density on OCTA increased in the ranibizumab group and decreased in the PRP group. Visual acuity gain was higher in the ranibizumab group than in the PRP group. Future multicenter trials addressing our limitations are required to verify the findings of this study.

背景:增殖性糖尿病视网膜病变(PDR)是一种严重的视力威胁疾病,如果不及时治疗,一半的高风险PDR患者可在5年内发展为法定失明。本研究旨在比较全视网膜光凝(PRP)和玻璃体内注射雷尼单抗在光学相干断层扫描血管造影(OCTA)上对首次治疗的PDR患者的径向乳头周围毛细血管(RPC)密度的影响。方法:这项开放标签、前瞻性、随机临床试验纳入了50例首次治疗的PDR伴视盘新生血管患者,并将其随机分为两组:1组患者间隔2周接受两次PRP治疗,2组患者间隔1个月接受3次玻璃体内雷尼珠单抗注射(0.5 mg),连续3个月。患者接受了全面的眼科检查,包括干预前和最后一次激光治疗或第一次玻璃体内注射雷尼单抗后每月进行的最佳矫正距离视力(BCDVA)测量(最小分辨角对数)和OCTA,随访3个月。在3个月的开始和结束时检测视野(VF)。结果:42只眼(84%)完成了3个月的随访,其中PRP组22只眼(88%),雷尼单抗组20只眼(80%)。两组在人口学特征、糖尿病病程、基线BCDVA、糖化血红蛋白水平、OCTA参数、VF指数和眼压方面具有可比性(均P > 0.05)。PRP组RPC密度从基线到随访3个月的变化明显低于雷尼单抗组(RPC密度变化的平均差异:- 3.61%;95%置信区间:- 5.57%至- 1.60%;P = 0.001)。PRP组从基线到3个月随访的logMAR变化中位数(四分位间距)(0.0[0.2])显著高于雷尼单抗组(- 0.15 [0.3];P < 0.05)。从基线到随访3个月,两组中央中央凹厚度的中位数变化差异显著(P = 0.001)。结论:在PDR和椎间盘新生血管形成的眼睛中,雷尼单抗组OCTA上RPC密度增加,PRP组降低。雷尼单抗组的视力增加高于PRP组。需要未来的多中心试验来解决我们的局限性,以验证本研究的结果。
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引用次数: 0
Pars plana vitrectomy for tractional diabetic macular edema with or without internal limiting membrane peeling. 伴或不伴内限制膜剥离的牵引性糖尿病黄斑水肿玻璃体切除术。
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1454
Abdelrahman Ahmed Ali Khattab, Mahmoud Mohammed Ahmed, Abdullah Hussein Hammed

Background: The effectiveness of internal limiting membrane (ILM) peeling in the surgical treatment of tractional diabetic macular edema (DME), although widely examined, remains controversial. This study aimed to assess the efficacy of pars plana vitrectomy (PPV) in the management of tractional DME and to highlight any benefits of additional ILM peeling.

Methods: This was an open-label, prospective, comparative, and interventional study that enrolled 50 eyes with tractional DME that underwent PPV and allocated each to one of two groups: group A consisted of 25 eyes that had no ILM peeling and group B consisted of 25 eyes that underwent ILM peeling. Postoperative assessments of best-corrected distance visual acuity (BCDVA) in the logarithm of minimal angle of resolution (logMAR) notation and central macular thickness (CMT) were performed at 1, 3, and 6 months postoperatively.

Results: At baseline, the two groups were comparable in terms of sex ratios, phakic status, insulin use, coexistence of hypertension, and mean (standard deviation [SD]) age, BCDVA, CMT, duration of diabetes mellitus, and glycosylated hemoglobin (HbA1c) levels. In group A, the mean (SD) BCDVA improved significantly from 0.89 (0.12) logMAR preoperatively to 0.64 (0.24) logMAR (P < 0.001), and the mean (SD) CMT declined significantly from 471.28 (80.83) µm to 228.20 (26.45) µm (P < 0.001), at the 6-month postoperative assessment. Likewise, in group B, the mean (SD) BCDVA improved significantly from 0.83 (0.10) logMAR preoperatively to 0.58 (0.24) logMAR (P < 0.001), and the mean (SD) CMT decreased significantly from 496.84 (89.82) µm to 226.20 (18.04) µm (P < 0.001), after 6 months. There were no significant differences between groups A and B in the changes in BCDVA (Delta BCDVA) or CMT (Delta CMT) at 1, 3, and 6 months postoperatively with respect to the baseline values (all P > 0.05). Postoperative complications were comparable between the two groups. A significant negative correlation was detected between the preoperative HbA1c level and BCDVA improvement in all participants (r = - 0.82; P < 0.001).

Conclusions: PPV is an effective treatment for tractional DME. Additional ILM peeling was not significantly associated with functional and anatomical benefits over a short period. Long-term glycemic control plays a role in vision gain after vitrectomy in patients with diabetes. Further long-term studies are required to verify our findings.

背景:内限制膜(ILM)剥离在手术治疗牵引性糖尿病性黄斑水肿(DME)中的有效性,虽然得到了广泛的研究,但仍存在争议。本研究旨在评估玻璃体切割(PPV)在治疗牵引性二甲内窥镜中的疗效,并强调额外的ILM剥离的任何益处。方法:这是一项开放标签、前瞻性、比较和干预性研究,招募了50只接受PPV的牵引性DME眼,并将每只眼分配到两组中的一组:A组包括25只未发生ILM剥离的眼,B组包括25只发生ILM剥离的眼。分别于术后1、3、6个月对最小分辨角(logMAR)对数进行最佳矫正距离视力(BCDVA)和中央黄斑厚度(CMT)评估。结果:在基线时,两组在性别比例、饮食状态、胰岛素使用、高血压共存、平均(标准差[SD])年龄、BCDVA、CMT、糖尿病持续时间和糖化血红蛋白(HbA1c)水平方面具有可比性。A组术后6个月平均(SD) BCDVA从术前0.89 (0.12)logMAR显著改善至0.64 (0.24)logMAR (P < 0.001),平均(SD) CMT从471.28(80.83)µm显著下降至228.20(26.45)µm (P < 0.001)。同样,B组6个月后平均(SD) BCDVA从术前的0.83 (0.10)logMAR显著提高到0.58 (0.24)logMAR (P < 0.001),平均(SD) CMT从496.84(89.82)µm显著降低到226.20(18.04)µm (P < 0.001)。A组与B组术后1、3、6个月BCDVA (Delta BCDVA)或CMT (Delta CMT)的变化与基线值比较,差异均无统计学意义(P > 0.05)。两组术后并发症无明显差异。术前HbA1c水平与BCDVA改善呈显著负相关(r = - 0.82;P < 0.001)。结论:PPV是治疗牵引性二甲醚的有效方法。在短时间内,额外的ILM剥离与功能和解剖学上的益处没有显著关联。长期血糖控制对糖尿病患者玻璃体切除术后视力恢复有重要作用。需要进一步的长期研究来验证我们的发现。
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引用次数: 1
Ocular dimensions by three-dimensional magnetic resonance imaging in emmetropic versus myopic school children. 三维磁共振成像在准斜视与近视学童中的应用。
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1447
Bariah Mohd-Ali, Low Yu Chen, Mizhanim Mohamad Shahimin, Norlaili Arif, Hamzaini Abdul Hamid, Wan Haslina Wan Abdul Halim, Siti Salasiah Mokri, Aqilah Baseri Huddin, Norhani Mohidin

Background: Magnetic resonance imaging (MRI) has been used to investigate eye shapes; however, reports involving children are scarce. This study aimed to determine ocular dimensions, and their correlations with refractive error, using three-dimensional MRI in emmetropic versus myopic children.

Methods: Healthy school children aged < 10 years were invited to take part in this cross-sectional study. Refraction and best-corrected distance visual acuity (BCDVA) were determined using cycloplegic refraction and a logarithm of the minimum angle of resolution (logMAR) chart, respectively. All children underwent MRI using a 3-Tesla whole-body scanner. Quantitative eyeball measurements included the longitudinal axial length (LAL), horizontal width (HW), and vertical height (VH) along the cardinal axes. Correlation analysis was used to determine the association between the level of refractive error and the eyeball dimensions.

Results: A total of 70 eyes from 70 children (35 male, 35 female) with a mean (standard deviation [SD]) age of 8.38 (0.49) years were included and analyzed. Mean (SD) refraction (spherical equivalent, SEQ) and BCDVA were -2.55 (1.45) D and -0.01 (0.06) logMAR, respectively. Ocular dimensions were greater in myopes than in emmetropes (all P < 0.05), with no significant differences according to sex. Mean (SD) ocular dimensions were LAL 24.07 (0.91) mm, HW 23.41 (0.82) mm, and VH 23.70 (0.88) mm for myopes, and LAL 22.69 (0.55) mm, HW 22.65 (0.63) mm, and VH 22.94 (0.69) mm for emmetropes. Significant correlations were noted between SEQ and ocular dimensions, with a greater change in LAL (0.46 mm/D, P < 0.001) than in VH (0.27 mm/D, P < 0.001) and HW (0.22 mm/D, P = 0.001).

Conclusions: Myopic eyeballs are larger than those with emmetropia. The eyeball elongates as myopia increases, with the greatest change in LAL, the least in HW, and an intermediate change in VH. These changes manifest in both sexes at a young age and low level of myopia. These data may serve as a reference for monitoring the development of refractive error in young Malaysian children of Chinese origin.

背景:磁共振成像(MRI)已被用于研究眼睛形状;然而,涉及儿童的报道很少。本研究的目的是确定眼尺寸,以及它们与屈光不正的相关性,使用三维MRI在准斜视和近视的儿童。方法:选取年龄< 10岁的健康学龄儿童进行横断面研究。分别采用睫状体屈光和对数最小分辨角(logMAR)图测定屈光和最佳矫正距离视力(BCDVA)。所有儿童均使用3特斯拉全身扫描仪进行MRI检查。定量眼球测量包括沿主轴的纵向轴长(LAL)、水平宽度(HW)和垂直高度(VH)。相关性分析用于确定屈光不正程度与眼球尺寸之间的关系。结果:共纳入70例儿童(男35例,女35例)70只眼,平均(标准差[SD])年龄为8.38(0.49)岁。平均(SD)折射(球面等效,SEQ)和BCDVA分别为-2.55 (1.45)D和-0.01 (0.06)logMAR。近视眼的眼尺寸大于近视眼(P < 0.05),性别差异无统计学意义。近视眼的平均眼尺寸(SD)为LAL 24.07 (0.91) mm、HW 23.41 (0.82) mm、VH 23.70 (0.88) mm;远视眼的平均眼尺寸(SD)为LAL 22.69 (0.55) mm、HW 22.65 (0.63) mm、VH 22.94 (0.69) mm。SEQ与眼尺寸之间存在显著相关性,LAL (0.46 mm/D, P < 0.001)的变化大于VH (0.27 mm/D, P < 0.001)和HW (0.22 mm/D, P = 0.001)。结论:近视眼比远视大。眼球随着近视的增加而拉长,LAL变化最大,HW变化最小,VH变化中等。这些变化在年轻时和低度数近视时男女皆有表现。这些数据可作为监测马来西亚华人儿童屈光不正发展的参考。
{"title":"Ocular dimensions by three-dimensional magnetic resonance imaging in emmetropic versus myopic school children.","authors":"Bariah Mohd-Ali,&nbsp;Low Yu Chen,&nbsp;Mizhanim Mohamad Shahimin,&nbsp;Norlaili Arif,&nbsp;Hamzaini Abdul Hamid,&nbsp;Wan Haslina Wan Abdul Halim,&nbsp;Siti Salasiah Mokri,&nbsp;Aqilah Baseri Huddin,&nbsp;Norhani Mohidin","doi":"10.51329/mehdiophthal1447","DOIUrl":"https://doi.org/10.51329/mehdiophthal1447","url":null,"abstract":"<p><strong>Background: </strong>Magnetic resonance imaging (MRI) has been used to investigate eye shapes; however, reports involving children are scarce. This study aimed to determine ocular dimensions, and their correlations with refractive error, using three-dimensional MRI in emmetropic versus myopic children.</p><p><strong>Methods: </strong>Healthy school children aged < 10 years were invited to take part in this cross-sectional study. Refraction and best-corrected distance visual acuity (BCDVA) were determined using cycloplegic refraction and a logarithm of the minimum angle of resolution (logMAR) chart, respectively. All children underwent MRI using a 3-Tesla whole-body scanner. Quantitative eyeball measurements included the longitudinal axial length (LAL), horizontal width (HW), and vertical height (VH) along the cardinal axes. Correlation analysis was used to determine the association between the level of refractive error and the eyeball dimensions.</p><p><strong>Results: </strong>A total of 70 eyes from 70 children (35 male, 35 female) with a mean (standard deviation [SD]) age of 8.38 (0.49) years were included and analyzed. Mean (SD) refraction (spherical equivalent, SEQ) and BCDVA were -2.55 (1.45) D and -0.01 (0.06) logMAR, respectively. Ocular dimensions were greater in myopes than in emmetropes (all <i>P</i> < 0.05), with no significant differences according to sex. Mean (SD) ocular dimensions were LAL 24.07 (0.91) mm, HW 23.41 (0.82) mm, and VH 23.70 (0.88) mm for myopes, and LAL 22.69 (0.55) mm, HW 22.65 (0.63) mm, and VH 22.94 (0.69) mm for emmetropes. Significant correlations were noted between SEQ and ocular dimensions, with a greater change in LAL (0.46 mm/D, <i>P</i> < 0.001) than in VH (0.27 mm/D, <i>P</i> < 0.001) and HW (0.22 mm/D, <i>P</i> = 0.001).</p><p><strong>Conclusions: </strong>Myopic eyeballs are larger than those with emmetropia. The eyeball elongates as myopia increases, with the greatest change in LAL, the least in HW, and an intermediate change in VH. These changes manifest in both sexes at a young age and low level of myopia. These data may serve as a reference for monitoring the development of refractive error in young Malaysian children of Chinese origin.</p>","PeriodicalId":36524,"journal":{"name":"Medical Hypothesis, Discovery, and Innovation in Ophthalmology","volume":"11 2","pages":"64-70"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d6/c7/mehdiophth-11-064.PMC10445301.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10467188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Intravitreal methotrexate infusion for prophylaxis of proliferative vitreoretinopathy after pars plana vitrectomy for rhegmatogenous retinal detachment. 甲氨蝶呤玻璃体静脉滴注预防玻璃体切除术后增殖性玻璃体视网膜病变。
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1452
Joseph Hany Fouad Aziz, Mohamed Abd Al-Hakim Zaki, Amany Abd El-Fattah El-Shazly, Tarek Mamoun, Reem Osama Abdel Ghaffar Helmy, Mohamed Hanafy Hashem

Background: Proliferative vitreoretinopathy (PVR) is the leading cause of recurrent retinal detachment after surgical repair of rhegmatogenous retinal detachment (RRD). Our study aimed to assess the efficacy and safety of intravitreal methotrexate infusion (IMI) for the prevention of PVR after pars plana vitrectomy (PPV) in eyes with RRD.

Methods: This prospective comparative interventional study was conducted from September 2020 to November 2021 at Ain Shams University Hospitals, Egypt. We recruited a consecutive, non-randomized sample of 47 eyes of 47 patients with RRD undergoing PPV. Participants were allocated to a control group or an intervention group that received IMI during surgery. Each group was subdivided into subgroups of eyes at high-risk of developing PVR and eyes with established preoperative PVR grade C. Outcome measures at the 3-month postoperative follow-up were the rate of retinal attachment, incidence of PVR, reoperation rate to flatten the retina, and changes in the retina and/or optic nerve function as assessed by full-field electroretinogram and flash visual evoked potential.

Results: Data from 47 eyes (23 and 24 eyes in the intervention and control groups, respectively) were evaluated. Subgroups IA, IB, and IIB each included 12 eyes, subgroup IIA included 11 eyes, and all subgroups had comparable sex ratios and age distributions. Postoperative PVR at 1 month and between 1 and 3 months was present in 13% and 4% of eyes in the intervention group, respectively. Reoperation to flatten the retina was required in 2 (9%) eyes in the intervention group, while 22 eyes (96%) had complete flattening of the retina at 3 months. No significant differences were found between the study groups and the corresponding subgroups regarding the outcome measures (all P > 0.05). No adverse events attributable to IMI were detected up to 3 months postoperatively.

Conclusions: Although IMI was safe for intraocular use in eyes with RRD and PVR grade C or a high risk of developing PVR, it did not affect the anatomical success rate or development of PVR up to 3 months after PPV. Further multicenter randomized clinical trials with longer follow-up periods and larger sample sizes are needed to verify these preliminary outcomes.

背景:增殖性玻璃体视网膜病变(PVR)是孔源性视网膜脱离(RRD)手术修复后复发性视网膜脱离的主要原因。本研究旨在评估甲氨蝶呤玻璃体内输注(IMI)预防RRD眼玻璃体切除术(PPV)后PVR的有效性和安全性。方法:这项前瞻性比较介入研究于2020年9月至2021年11月在埃及艾因沙姆斯大学医院进行。我们招募了一个连续的、非随机的样本,包括47名接受PPV治疗的RRD患者的47只眼睛。参与者被分配到对照组或在手术期间接受IMI的干预组。每组再细分为发生PVR的高危眼和术前PVR为c级眼两组。术后3个月随访的结果是视网膜附着率、PVR发生率、再手术平视网膜率、视网膜和/或视神经功能的变化(通过全视野视网膜电图和闪烁视觉诱发电位评估)。结果:对47只眼(干预组23只,对照组24只)的数据进行评估。亚组IA、IB和IIB各包括12只眼睛,亚组IIA包括11只眼睛,所有亚组的性别比例和年龄分布具有可比性。干预组术后1个月和1 - 3个月的PVR发生率分别为13%和4%。干预组2只眼(9%)需要再次手术使视网膜变平,22只眼(96%)在3个月时视网膜完全变平。各研究组与相应亚组在结局指标上无显著差异(均P > 0.05)。术后3个月未发现IMI引起的不良事件。结论:虽然IMI在RRD和PVR C级或发生PVR高风险的眼睛中是安全的,但在PPV后3个月内,IMI对PVR的解剖成功率和发展没有影响。进一步的多中心随机临床试验需要更长的随访期和更大的样本量来验证这些初步结果。
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引用次数: 0
Safety and efficacy of topical tacrolimus 0.03% in the management of vernal keratoconjunctivitis: a non-randomized controlled clinical trial. 0.03%局部他克莫司治疗春性角膜结膜炎的安全性和有效性:一项非随机对照临床试验
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.51329/mehdiophthal1446
Mahmoud Eltagoury, Waleed Abou Samra, Ehab Ghoneim

Background: Vernal keratoconjunctivitis (VKC) is a bilateral, recurrent, chronic conjunctival inflammatory disease with seasonal exacerbations. This study aimed to assess the efficacy and safety of tacrolimus 0.03% eye ointment in the management of chronic VKC.

Methods: This was an open-label, prospective, non-randomized, comparative interventional study that enrolled 50 patients with chronic VKC, who were allocated to one of two groups. The first group was treated with tacrolimus 0.03% eye ointment twice daily for 2 months then once daily for 2 months, followed by once every other day for another 2 months. The control group was treated with standard anti-allergic drugs, topical fluorometholone 0.1% eye drops three times daily for 2 weeks and gradually tapered for another 2 weeks, with topical olopatadine 0.1% administered twice daily during the follow-up period. Disease severity was assessed using a four-point scale for symptoms and signs. Treatment efficacy was assessed by analyzing changes in symptoms and signs, and by clinical photography.

Results: Fifty patients with bilateral chronic VKC completed the follow-up. The mean (standard deviation) ages of the tacrolimus and control groups were comparable (16.20 [5.10] years versus 16.48 [4.19] years, P > 0.05). The most commonly reported symptom was itching, and the most common signs were papillary hypertrophy and conjunctival hyperemia. All symptoms and signs were significantly reduced after treatment in both groups. The tacrolimus group showed a more significant improvement at 3 and 6 months in the mean composite symptom score (both P < 0.05) and in the mean composite sign score (both P < 0.05). Regarding complications, one case of increased intraocular pressure occurred in the control group (4%) after 2 weeks of steroid treatment, while there were no complications in the tacrolimus group, except for some reports of stinging sensation, which was well tolerated.

Conclusions: Treatment of chronic bilateral VKC with tacrolimus 0.03% eye ointment is effective and safe. It could be considered an alternative treatment to reduce steroid-associated complications in patients with chronic VKC. Future double-blinded clinical trials with a longer follow-up period are necessary to confirm our findings and to determine the long-term safety of topical tacrolimus 0.03% ointment in VKC.

背景:春性角膜结膜炎(VKC)是一种双侧、复发性、慢性结膜炎症性疾病,有季节性加重。本研究旨在评价0.03%他克莫司眼膏治疗慢性VKC的疗效和安全性。方法:这是一项开放标签、前瞻性、非随机、比较介入研究,纳入了50名慢性VKC患者,他们被分为两组。第一组患者给予0.03%他克莫司眼膏,每日2次,连用2个月,然后每日1次,连用2个月,之后每隔一天1次,连用2个月。对照组给予标准抗过敏药物,0.1%氟美洛酮滴眼液,每日3次,连用2周后逐渐减量,随访期间0.1%奥洛他定每日2次。使用症状和体征的四分制评估疾病严重程度。通过分析症状和体征的变化以及临床摄影来评估治疗效果。结果:50例双侧慢性VKC患者完成随访。他克莫司组和对照组的平均(标准差)年龄具有可比性(16.20[5.10]岁vs . 16.48[4.19]岁,P > 0.05)。最常见的症状是瘙痒,最常见的体征是乳头肥大和结膜充血。两组患者治疗后症状和体征均明显减轻。他克莫司组在3个月和6个月时的平均综合症状评分和平均综合体征评分均有更显著的改善(P < 0.05)。在并发症方面,对照组在类固醇治疗2周后出现1例眼压升高(4%),而他克莫司组除有刺痛感报道外,无并发症,耐受性良好。结论:0.03%他克莫司眼膏治疗慢性双侧VKC有效、安全。它可以被认为是减少慢性VKC患者类固醇相关并发症的替代治疗方法。未来需要更长的随访期的双盲临床试验来证实我们的发现,并确定0.03%他克莫司软膏外用在VKC中的长期安全性。
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引用次数: 1
Preservative-free versus preserved latanoprost eye drops for reducing intraocular pressure: a non-inferiority phase III randomized, multi-center, single-blind, parallel-group controlled trial 无防腐剂与保存的拉坦前列素滴眼液降低眼压:一项非劣效性III期随机、多中心、单盲、平行组对照试验
Q2 Medicine Pub Date : 2021-02-28 DOI: 10.51329/MEHDIOPHTHAL1413
P. Theodosiadis, A. Konstas, I. Halkiadakis, Vasiliki Dimera, Dimitrios Koufakis, C. Georgakopoulos, E. Kanonidou, E. Zintzaras, K. Soulele, Antonios Margaritis, Lida Kalantzi
Background: The aim of this study was to test the non-inferiority of preservative-free (PF) latanoprost 50 μg/mL multi-dose ophthalmic solution versus the marketed benzalkonium chloride (BAK)-preserved latanoprost 50 μg/mL ophthalmic solution in patients with open-angle glaucoma and patients with ocular hypertension. Methods: This was a prospective, national, randomized, multi-center, observer-blind, parallel-group controlled clinical trial. Patients were randomized to receive either PF or BAK-preserved latanoprost once daily for 12 weeks. The primary endpoint was the change in intraocular pressure (IOP) at 8:00 AM in the affected eye between the end of the treatment (week 12) and the baseline (week 0). Secondary measurements were taken at weeks 2 and 6, with IOP being recorded at 8:00 AM, 12:00 PM, and 4:00 PM. Results: A total of 158 patients were included in the per protocol (PP) population (77 in the PF latanoprost treatment arm and 81 patients in the BAK-preserved latanoprost treatment arm). PF latanoprost was non-inferior to BAK-preserved latanoprost in reducing IOP at 8:00 AM in the study eye from the baseline (week 0) to the end of the treatment (week 12). The point estimate of the between-treatment difference was 0.1 mmHg (95% confidence interval: -0.646, 0.847). Mean between-group differences in IOP reduction from the baseline to each of the secondary measurements were also similar between the two treatment arms. The two treatments were well tolerated and had comparable adverse event profiles. Conclusions: PF latanoprost was non-inferior to BAK-preserved latanoprost in reducing IOP in patients with open-angle glaucoma or ocular hypertension. Both treatments were well tolerated.
背景:本研究的目的是检验无保鲜剂(PF)拉坦前列素50 μg/mL多剂量眼液与市售苯扎氯铵(BAK)保存的拉坦前列素50 μg/mL眼液在开角型青光眼和高眼压患者中的非效性。方法:这是一项前瞻性、全国性、随机、多中心、观察盲、平行组对照临床试验。患者随机接受PF或bak保存的拉坦前列素,每天一次,持续12周。主要终点是治疗结束(第12周)和基线(第0周)之间上午8:00时受影响眼内眼压(IOP)的变化。在第2周和第6周进行二次测量,记录上午8:00、中午12:00和下午4:00的IOP。结果:共有158例患者被纳入每个方案(PP)人群(77例在PF拉坦前列素治疗组,81例在bac保存的拉坦前列素治疗组)。从基线(第0周)到治疗结束(第12周),PF拉坦前列素在降低研究眼上午8:00 IOP方面不逊于bac保存的拉坦前列素。治疗间差异的点估计值为0.1 mmHg(95%可信区间:-0.646,0.847)。从基线到每一次要测量的IOP降低的平均组间差异在两个治疗组之间也相似。这两种治疗方法耐受性良好,不良事件相似。结论:PF拉坦前列素在降低开角型青光眼或高眼压患者的IOP方面不逊于bak保存的拉坦前列素。两种治疗方法均耐受良好。
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Medical Hypothesis, Discovery, and Innovation in Ophthalmology
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