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一项关于新生血管性年龄相关性黄斑变性临床特征及视觉预后的前瞻性观察研究。

A Prospective Observational Study on Clinical Profile and Visual Outcomes in Neovascular Age-Related Macular Degeneration.

作者信息

Dalai Ramamani, Bedant Snigdha S, Rout Rajashree, Panda Bijnya B

机构信息

Ophthalmology, Fakir Mohan Medical College and Hospital, Balasore, IND.

Ophthalmology, Srirama Chandra Bhanja Medical College and Hospital, Cuttack, IND.

出版信息

Cureus. 2024 Jan 22;16(1):e52731. doi: 10.7759/cureus.52731. eCollection 2024 Jan.

Abstract

Background and objectives Over the years, several treatment options have been developed for neovascular age-related macular degeneration (AMD), the most notable being intravitreal injections of anti-vascular endothelial growth factor drugs. The rationale for treating neovascular AMD is to preserve and improve central vision, enhance the quality of life for affected individuals, stabilize or improve vision, and prevent further structural damage to the macula. The objective of the present study was to evaluate the clinical course of different disease types of neovascular age-related macular degeneration and their treatment response to anti-vascular endothelial growth factor (anti-VEGF) injections. Methods This prospective observational study was conducted at a tertiary care referral hospital in Eastern India during October 2019 and September 2021. Patients diagnosed with neovascular AMD attending our Outpatient department and retina clinic were recruited for the study. An experienced ophthalmologist examined all patients, meeting the inclusion criteria. The clinical profile, including initial best corrected visual acuity (BCVA), ophthalmoscopic, fluorescein angiographic, and optical coherence tomography (OCT) findings of different patterns of neovascular AMD, were collected and analyzed. Patients were subjected to intravitreal Ranibizumab every month for three months and then on a when-required basis. Visual outcomes were recorded at each follow-up, and a comparison was done between initial and final visual acuity. Descriptive statistics were used for analysis, with p< 0.05 taken as statistically significant. Results A total of 72 patients were included in the study. Fundus fluorescein angiography revealed that 52.78% were classic, 15.28% were minimally classic, and 31.94% were of occult variety. 41.66% of lesions were subfoveal in location, 47.22% were juxtafoveal, and 11.11% lesions were extrafoveal in location. The mean BCVA was Log MAR (Logarithm of the Minimum Angle of Resolution) 1.061±0.25. The average number of intravitreal Ranibizumab injections given to each eye was five. BCVA of patients after the third injection was log MAR 0.818±0.296. There was a significant improvement in mean BCVA from baseline 1.061±0.254 to 0.787±0.317 after the study (p-valve: p<0.05). After the first injection, 49 patients (68.05%) experienced an initial improvement of at least one line, 20 patients (27.77%) did not exhibit any improvement, and 3 patients (4.16%) had a decline of one line in Snellen's visual acuity chart. Over the follow-up period,10 showed improvement in 1 line in the Snellen chart after subsequent injection. At the end of the study, six patients showed no change, and four patients showed deterioration after the completion of injections. No adverse events were noted during the study period. Conclusions Intravitreal Ranibizumab is effective in improving visual outcomes in treatment-naïve individuals with neovascular age-related macular degeneration. The decision for repeat intravitreal anti-VEGF injection should be based on OCT findings of subretinal fluid, pigment epithelial detachment, and cystoid macular edema as an indicator of disease activity. This can also lessen the number of intravitreal injections and morbidity in these patients.

摘要

背景与目的 多年来,已开发出多种治疗新生血管性年龄相关性黄斑变性(AMD)的方法,其中最显著的是玻璃体内注射抗血管内皮生长因子药物。治疗新生血管性AMD的基本原理是保护和改善中心视力,提高受影响个体的生活质量,稳定或改善视力,并防止黄斑进一步受到结构损伤。本研究的目的是评估不同疾病类型的新生血管性年龄相关性黄斑变性的临床病程及其对抗血管内皮生长因子(抗VEGF)注射的治疗反应。

方法 这项前瞻性观察性研究于2019年10月至2021年9月在印度东部的一家三级医疗转诊医院进行。招募到我院门诊和视网膜诊所就诊的被诊断为新生血管性AMD的患者参与研究。一位经验丰富的眼科医生对所有符合纳入标准的患者进行了检查。收集并分析了临床资料,包括新生血管性AMD不同模式的初始最佳矫正视力(BCVA)、检眼镜检查、荧光素血管造影和光学相干断层扫描(OCT)结果。患者每月接受一次玻璃体内注射雷珠单抗,共注射三个月,之后根据需要进行注射。在每次随访时记录视力结果,并对初始视力和最终视力进行比较。采用描述性统计进行分析,以p<0.05为具有统计学意义。

结果 本研究共纳入72例患者。眼底荧光素血管造影显示,52.78%为典型性,15.28%为极小典型性,31.94%为隐匿性。41.66%的病变位于黄斑中心凹下,47.22%位于黄斑中心凹旁,11.11%的病变位于黄斑中心凹外。平均BCVA为Log MAR(最小分辨角对数)1.061±0.25。每只眼睛平均接受玻璃体内注射雷珠单抗的次数为5次。第三次注射后患者的BCVA为Log MAR 0.818±0.296。研究后平均BCVA从基线的1.061±0.254显著改善至0.787±0.317(p值:p<0.05)。第一次注射后,49例患者(68.05%)的视力至少提高了一行,20例患者(27.77%)没有任何改善,3例患者(4.16%)的斯内伦视力表视力下降了一行。在随访期间,10例患者在后续注射后斯内伦视力表视力提高了一行。研究结束时,6例患者视力无变化,4例患者在注射完成后视力恶化。研究期间未观察到不良事件。

结论 玻璃体内注射雷珠单抗对初治的新生血管性年龄相关性黄斑变性患者改善视力有效。重复玻璃体内抗VEGF注射的决策应基于OCT检查发现的视网膜下液、色素上皮脱离和黄斑囊样水肿等疾病活动指标。这也可以减少这些患者的玻璃体内注射次数和发病率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a3e/10880741/dbe3f85e2da4/cureus-0016-00000052731-i01.jpg

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