Hawkins Barbara S, Bressler Neil M, Miskala Päivi H, Bressler Susan B, Holekamp Nancy M, Marsh Marta J, Redford Maryann, Schwartz Steven D, Sternberg Paul, Thomas Matthew A, Wilson David J
SST Coordinating Center, Wilmer Clinical Trials and Biometry, 550 North Broadway, 9th Floor, Baltimore, MD 21205-2010, USA.
Ophthalmology. 2004 Nov;111(11):1967-80. doi: 10.1016/j.ophtha.2004.07.021.
To present visual acuity (VA) and related findings from patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of subfoveal choroidal neovascularization secondary to age-related macular degeneration (SST Group N Trial).
Randomized clinical trial.
Eligible patients had age-related macular degeneration with subfoveal choroidal neovascularization, some with a classic pattern on fluorescein angiography, and best-corrected VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no treatment in the macula. Any contiguous blood had to account for <50% of the total area occupied by the subfoveal lesion (maximum size, 9.0 disc areas [22.9 mm2]).
Randomization was stratified by VA and by clinical center. All patients were scheduled for study examinations at 3, 6, 12, and 24 months after enrollment for assessment of study outcomes.
A successful outcome was defined a priori to be either improvement of BCVA or VA no more than 1 line (7 letters) worse than baseline at the 24-month examination.
Of 454 patients enrolled, 228 study eyes were assigned to observation and 226 to surgery. The percentages of eyes that had successful outcomes were similar in the 2 arms: 44% assigned to observation and 41% assigned to surgery. Median VA losses from baseline to the 24-month examination were 2.1 lines (10.5 letters) in the observation arm and 2.0 lines (10 letters) in the surgery arm. Median VA declined from 20/100 at baseline to 20/400 at 24 months in both arms. No subgroup of patients was identified in which submacular surgery led to better VA outcomes. In the surgery arm, 55 (39%) of 142 initially phakic eyes had cataract surgery by the 24-month examination, compared with 6 (5%) of 133 eyes in the observation arm. Rhegmatogenous retinal detachment occurred in 12 surgery eyes (5%) and 1 observation eye.
Submacular surgery, as performed in this clinical trial, did not improve or preserve VA for 24 months in more eyes than observation and is not recommended for patients with similar lesions. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.
呈现参与一项黄斑下手术试验（SST）的患者的视力（VA）及相关结果，该试验评估手术切除与观察年龄相关性黄斑变性继发的黄斑下脉络膜新生血管（SST N组试验）。
随机临床试验。
符合条件的患者患有年龄相关性黄斑变性伴黄斑下脉络膜新生血管，部分患者在荧光素血管造影上有典型表现，且一只眼（研究眼）的最佳矫正视力（BCVA）为20/100至20/800，该眼黄斑未接受过任何治疗。任何连续的出血面积必须占黄斑下病变总面积的<50%（最大尺寸为9.0视盘面积[22.9平方毫米]）。
随机分组按视力和临床中心分层。所有患者在入组后3、6、12和24个月安排进行研究检查，以评估研究结果。
预先定义成功结果为在24个月检查时BCVA改善或视力下降不超过1行（7个字母）。
在454例入组患者中，228只研究眼被分配至观察组，226只被分配至手术组。两组中获得成功结果的眼的百分比相似：观察组为44%，手术组为41%。从基线至24个月检查时，观察组视力中位数下降2.1行（10.5个字母），手术组下降2.0行（10个字母）。两组的视力中位数从基线时的20/100下降至24个月时的20/400。未发现黄斑下手术能带来更好视力结果的患者亚组。在手术组中，142只初始有晶状体眼中有55只（39%）在24个月检查时接受了白内障手术，而观察组133只眼中有6只（5%）接受了白内障手术。孔源性视网膜脱离在1名手术组患者（5%）和1名观察组患者中发生。
在本临床试验中进行的黄斑下手术，在24个月内改善或保留视力的眼数并不比观察更多，因此不建议患有类似病变的患者采用。本文包含额外的仅在线材料，可在http://www.ophsource.com/periodicals/ophtha获取。
