Danis R P, Ciulla T A, Pratt L M, Anliker W
Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, USA.
Retina. 2000;20(3):244-50.
To examine the effects of intravitreal injection of 4.0 mg triamcinolone acetonide on the visual and clinical course of exudative age-related macular degeneration.
A randomized clinical trial of a single injection of triamcinolone acetonide into the vitreous cavity of experimental eyes at baseline versus observation of untreated subjects was performed in 27 patients followed up for 6 months. Inclusion criteria included exudative age-related macular degeneration with subfoveal or occult choroidal neovascularization, and visual acuity between 20/40 and 20/400. Examination, acuity assessment, fundus photography, and fluorescein angiography were performed at baseline and at 3 and 6 months after enrollment. LogMAR visual acuity was compared between groups by a repeated measures analysis of variance model. Masked assessment of photographic studies was performed and groups were compared with Fisher's exact test.
Visual acuity was significantly better in the treated group compared with control subjects at 3 and 6 months (P < 0.005). Fundus photography and angiography were more likely to show stability or improvement at 3 and 6 months in the treated group (P = 0.05). Intraocular pressure elevation was seen in 25% of treated patients, but was controlled with topical medications. Progression of cataract was more frequently seen in the treated group.
Intravitreal triamcinolone acetonide may provide short-term improvement in visual acuity and fundus findings in exudative macular degeneration. These findings must be considered preliminary and should be followed by multicenter, masked, placebo-controlled trials with long-term follow-up.
研究玻璃体内注射4.0毫克曲安奈德对渗出性年龄相关性黄斑变性的视力及临床病程的影响。
对27例患者进行了一项随机临床试验，在基线时向实验眼的玻璃体腔单次注射曲安奈德，并对未治疗的受试者进行观察，随访6个月。纳入标准包括伴有黄斑中心凹下或隐匿性脉络膜新生血管的渗出性年龄相关性黄斑变性，以及视力在20/40至20/400之间。在基线时以及入组后3个月和6个月进行检查、视力评估、眼底照相和荧光素血管造影。通过重复测量方差分析模型比较两组间的最小分辨角对数视力。对摄影研究进行盲法评估，并采用Fisher精确检验比较组间差异。
在3个月和6个月时，治疗组的视力明显优于对照组（P<0.005）。在3个月和6个月时，治疗组的眼底照相和血管造影更有可能显示稳定或改善（P = 0.05）。25%的治疗患者出现眼压升高，但通过局部用药得到控制。治疗组白内障进展更为常见。
玻璃体内注射曲安奈德可能会使渗出性黄斑变性的视力和眼底表现得到短期改善。这些发现必须被视为初步结果，后续应开展多中心、盲法、安慰剂对照试验并进行长期随访。
