Finger P T, Gelman Y P, Berson A M, Szechter A
New York Eye and Ear Infirmary, New York City, New York 10003, USA.
Br J Ophthalmol. 2003 Dec;87(12):1497-503. doi: 10.1136/bjo.87.12.1497.
To report 7 year results of ophthalmic plaque radiotherapy for exudative macular degeneration.
In a phase I clinical trial, 30 patients (31 eyes) were treated with ophthalmic plaque irradiation for subfoveal exudative macular degeneration. Radiation was delivered to a mean 2 mm from the inner sclera (range 1.2-2.4) prescription point calculated along the central axis of the plaque. The mean prescription dose was 17.62 Gy (range 12.5-24) delivered over 34 hours (range 18-65). Early Treatment Diabetic Retinopathy Study (ETDRS) type standardised visual acuity determinations, ophthalmic examinations, and angiography were performed before and after treatment. Clinical evaluations were performed in a non-randomised and unmasked fashion.
At 33.3 months (range 3-4), 17 of 31 (55%) eyes had lost 3 or more lines of vision on the ETDRS chart, five (16%) had improved 3 or more lines, and the remaining nine (29%) were within 2 lines of their pretreatment visual acuity measurement. Overall, 45% of patients were within or improved more than 2 lines of their initial visual acuity. Five eyes developed macular scars, eight developed subsequent neovascularisation or haemorrhage, and three progressed through therapy. Two patients were lost to follow up. The most common finding of patients followed for 6 or more months (n=18 of 29 (62%)) was regression or stabilisation of the exudative process. No radiation retinopathy, optic neuropathy, or cataracts could be attributed to irradiation.
Ophthalmic plaque radiation can be used to treat exudative macular degeneration. At the dose and dose rates employed, most patients experienced decreased exudation or stabilisation of their maculas. No sight limiting radiation complications were noted during 7 year follow up. Owing to the variable natural course of this disease, a prospective randomised clinical trial should be performed to evaluate the efficacy of plaque radiation therapy for exudative macular degeneration.
报告渗出性黄斑变性眼内敷贴放疗7年的结果。
在一项I期临床试验中,30例患者(31只眼)接受了针对黄斑中心凹下渗出性黄斑变性的眼内敷贴照射。辐射剂量沿敷贴器中心轴计算,从内巩膜平均2毫米处(范围1.2 - 2.4毫米)的处方点给予。平均处方剂量为17.62 Gy(范围12.5 - 24 Gy),在34小时内给予(范围18 - 65小时)。在治疗前后进行早期糖尿病性视网膜病变研究(ETDRS)类型的标准化视力测定、眼科检查和血管造影。临床评估以非随机、非盲法进行。
在33.3个月(范围3 - 4个月)时,31只眼中有17只(55%)在ETDRS视力表上视力下降3行或更多,5只(16%)视力提高3行或更多,其余9只(29%)与治疗前视力测量结果相差2行以内。总体而言,45%的患者视力在初始视力范围内或提高超过2行。5只眼出现黄斑瘢痕,8只眼随后出现新生血管或出血,3只眼在治疗过程中病情进展。2例患者失访。随访6个月或更长时间的患者中最常见的发现(29例中的18例(62%))是渗出过程的消退或稳定。没有辐射性视网膜病变、视神经病变或白内障可归因于照射。
眼内敷贴放疗可用于治疗渗出性黄斑变性。在所采用的剂量和剂量率下,大多数患者黄斑渗出减少或病情稳定。在7年随访期间未观察到导致视力受限的辐射并发症。由于该疾病自然病程的多变性,应进行前瞻性随机临床试验以评估敷贴放疗对渗出性黄斑变性的疗效。