Hawkins Barbara S, Bressler Neil M, Bressler Susan B, Davidorf Frederick H, Hoskins John C, Marsh Marta J, Miskala Päivi H, Redford Maryann, Sternberg Paul, Thomas Matthew A, Toth Cynthia A
Arch Ophthalmol. 2004 Nov;122(11):1597-611. doi: 10.1001/archopht.122.11.1597.
To present visual acuity findings and related outcomes from eyes of patients enrolled in a randomized trial conducted by the Submacular Surgery Trials (SST) Research Group (SST Group H Trial) to compare surgical removal vs observation of subfoveal choroidal neovascular lesions that were either idiopathic or associated with ocular histoplasmosis.
Eligible patients 18 years or older had subfoveal choroidal neovascularization (new or recurrent) that included a classic component on fluorescein angiography and best-corrected visual acuity of 20/50 to 20/800 in 1 eye ("study eye"). Patients were examined 3, 6, 12, and 24 months after enrollment to assess study outcomes and adverse events. Best-corrected visual acuity was measured by a masked examiner at the 24-month examination. A successful outcome was defined a priori as 24-month visual acuity better or no more than 1 line (7 letters) worse than at baseline.
Among 225 patients enrolled (median visual acuity 20/100), 113 study eyes were assigned to observation and 112 to surgery. Forty-six percent of the eyes in the observation arm and 55% in the surgery arm had a successful outcome (success ratio, 1.18; 95% confidence interval, 0.89-1.56). Median visual acuity at the 24-month examination was 20/250 among eyes in the observation arm and 20/160 for eyes in the surgery arm. The prespecified subgroup of eyes with visual acuity worse than 20/100 at baseline (n = 92) had more successes with surgery; 31 (76%) of 41 eyes in the surgery arm vs 20 (50%) of 40 eyes in the observation arm examined at 24 months (success ratio, 1.53; 95% confidence interval, 1.08-2.16). Five (4%) of 111 eyes in the surgery arm subsequently had a rhegmatogenous retinal detachment. Twenty-seven (24%) of 112 initially phakic eyes in the surgery arm (none in the observation arm) had cataract surgery during follow-up, all among patients older than 50 years. Recurrent choroidal neovascularization developed by the 24-month examination in 58% of surgically treated eyes.
Overall, findings supported no benefit or a smaller benefit to surgery than the trial was designed to detect. Findings support consideration of surgery for eyes with subfoveal choroidal neovascularization and best-corrected visual acuity worse than 20/100 that meet other eligibility criteria for the SST Group H Trial. Other factors that may influence the treatment decision include the risks of retinal detachment, cataract among older patients, and recurrent choroidal neovascularization and the possibility that additional treatment will be required after submacular surgery.
呈现黄斑下手术试验（SST）研究组开展的一项随机试验（SST H组试验）中患者眼部的视力结果及相关转归，以比较手术切除与观察特发性或与眼组织胞浆菌病相关的黄斑下脉络膜新生血管病变的效果。
年龄在18岁及以上的符合条件患者，其黄斑下脉络膜新生血管（新发病例或复发病例）在荧光素血管造影检查中有典型成分，且一只眼（“研究眼”）的最佳矫正视力为20/50至20/800。患者在入组后3、6、12和24个月接受检查，以评估研究结果和不良事件。在24个月检查时，由一位不知情的检查者测量最佳矫正视力。预先设定成功结果的定义为24个月时的视力比基线时更好或比基线时差不超过1行（7个字母）。
在225名入组患者中（中位视力为20/100），113只研究眼被分配至观察组，112只被分配至手术组。观察组46%的眼和手术组55%的眼获得了成功结果（成功比例为1.18；95%置信区间为0.89 - 1.56）。观察组眼在24个月检查时的中位视力为20/250，手术组眼为20/160。基线视力差于20/100的预先设定亚组眼（n = 92）手术成功的更多；在24个月时检查，手术组41只眼中有31只（76%）成功，而观察组40只眼中有20只（50%）成功（成功比例为1.53；95%置信区间为1.08 - 2.16）。手术组111只眼中有5只（4%）随后发生了孔源性视网膜脱离。手术组112只最初有晶状体眼（观察组无）中有27只（24%）在随访期间接受了白内障手术，均为年龄大于50岁的患者。在接受手术治疗的眼中，58%在24个月检查时出现了脉络膜新生血管复发。
总体而言，研究结果表明手术无益处或益处小于试验设计所预期检测到的。研究结果支持对黄斑下脉络膜新生血管且最佳矫正视力差于20/100且符合SST H组试验其他入选标准的眼考虑手术治疗。其他可能影响治疗决策的因素包括视网膜脱离风险、老年患者白内障、脉络膜新生血管复发以及黄斑下手术后可能需要额外治疗的可能性。
