Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: Ophthalmic findings - SST report no. 13
Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: Ophthalmic findings - SST report no. 13
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DOI：
10.1016/j.ophtha.2004.07.023
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发表时间：
2004-11-01
期刊：
影响因子：
13.7
通讯作者：
Williams, GA
中科院分区：
文献类型：
--
作者：
Bressler, NM;Bressler, SB;Williams, GA
目的：介绍入选黄斑下手术试验（SST）的患者的最佳矫正视力（BCVA）结果和其他临床结局，评价手术切除与观察与年龄相关性黄斑变性相关的主要出血性中心凹下脉络膜新生血管（CNV）。设计：随机临床试验（SST B组试验）。参与者：符合条件的患者的中心凹下脉络膜新生血管病变大于3.5个椎间盘面积（8.9 mm（2））由至少50%的血液组成（血液或CNV位于中心凹无血管区的中心之下）和BCVA为20/100的研究眼的光感。患者在入组时被随机分配观察或手术清除血液和任何相关的CNV。主要结果测量：成功的结果被先验地定义为视力（VA）的改善，VA没有变化，或基于意向治疗分析，从基线到24个月检查，VA下降不超过1行（7个字母）。在入组的336例患者中，168例被分配至每个治疗组;治疗组按基线特征平衡。在基线后3个月至36个月的1501次预期检查中，进行了1370次（91%）。在24个月时，56%的手术眼视力丧失大于或等于2行（大于或等于8个字母），而59%的观察眼视力丧失。尽管VA严重丧失不是主要关注的结局，但手术更常预防VA丧失：24个月检查时，观察组为36%，手术组为21%（x（2）p = 0.004）。在最初有晶状体眼中，手术组在24个月内接受白内障手术的累积百分比为44%，而观察组为6%。手术组中有27只眼（16%）发生孔源性视网膜脱离（RD），而观察组为3只眼（2%）。SST B组试验中进行的黄斑下手术并未增加VA稳定或改善的机会（关注的主要结局），并且与孔源性RD的高风险相关，但与观察结果相比，确实降低了重度VA丧失的风险。(C)2004年，美国眼科学会。
Purpose: To present best-corrected visual acuity (BCVA) findings and other clinical outcomes from eyes of patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of predominantly hemorrhagic subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration.Design: Randomized clinical trial (SST Group B Trial).Participants: Eligible patients had subfoveal choroidal neovascular lesions greater than 3.5 disk areas (8.9 mm(2)) composed of at least 50% blood (either blood or CNV underlying the center of the foveal avascular zone) and BCVA of 20/100 to light perception in the study eye.Intervention: Patients were assigned randomly at time of enrollment to observation or surgical removal of blood and any associated CNV.Main Outcome Measure: A successful outcome was defined a priori as either improvement in visual acuity (VA), no change in VA, or a decline in VA of no more than 1 line (7 letters) from baseline to the 24-month examination based on an intent-to-treat analysis.Results. Of 336 patients enrolled, 168 were assigned to each treatment arm; treatment arms were balanced by baseline characteristics. Of 1501 expected examinations 3 months through 36 months after baseline, 1370 (91%) were performed. Loss of greater than or equal to2 lines (greater than or equal to8 letters) of VA occurred in 56% of surgery eyes, versus 59% of observation eyes examined at 24 months. Although severe loss of VA was not the primary outcome of interest, surgery more often prevented such loss: 36% in the observation arm versus 21% in the surgery arm at the 24-month examination (x(2) p = 0.004). Of initially phakic eyes, the cumulative percentage that had undergone cataract surgery by 24 months was 44% in the surgery arm, compared with 6% in the observation arm. Twenty-seven eyes (16%) in the surgical arm, compared with 3 eyes (2%) in the observation arm, had a rhegmatogenous retinal detachment (RD).Conclusions: Submacular surgery as performed in the SST Group B Trial did not increase the chance of stable or improved VA (the primary outcome of interest) and was associated with a high risk of rhegmatogenous RD, but did reduce the risk of severe VA loss in comparison with observation. (C) 2004 by the American Academy of Ophthalmology.