Bressler N M, Maguire M G, Murphy P L, Alexander J, Margherio R, Schachat A P, Fine S L, Stevens T S, Bressler S B
Retinal Vascular Center, Wilmer Ophthalmological Institute, Johns Hopkins University School of Medicine, Baltimore, Md, USA.
Arch Ophthalmol. 1996 Dec;114(12):1456-64. doi: 10.1001/archopht.1996.01100140654002.
To determine the effects of macular scatter ("grid") laser photocoagulation compared with observation on the visual function of eyes with subfoveal choroidal neovascularization (CNV) that has poorly demarcated boundaries and to provide preliminary data for the evaluation of the feasibility and design of a larger, definitive trial.
Randomized pilot clinical trial.
Two tertiary care retinal referral practices.
Symptomatic individuals with subfoveal CNV secondary to age-related macular degeneration in whom fluorescein angiography showed occult CNV with poorly demarcated boundaries; classic CNV was allowed but did not need to be present for entry into the study.
Change in visual acuity from baseline to specified time periods.
Fifty-two eyes were assigned to observation. Fifty-one eyes were assigned randomly to treatment consisting of macular scatter ("grid") laser photocoagulation to the area of CNV. The treatment protocol for 8 of these eyes also included confluent laser photocoagulation to areas of classic CNV. The average visual acuity decrease from baseline was greater in the treated than in the observed group. The difference between these groups was greatest within the first year after study enrollment. At 24 months, slightly more than 40% of the eyes in each group had lost 6 or more lines of visual acuity. Similar results were noted for the subgroup of eyes initially with angiographic features of occult CNV but no classic CNV.
These short-term study results suggest that macular scatter ("grid") laser treatment is not beneficial and is possibly harmful compared with observation for symptomatic subfoveal CNV with poorly demarcated boundaries in age-related macular degeneration. With or without treatment, a significant proportion of these patients are at risk of severe visual loss within 2 years of seeking treatment, even when the eye initially has occult CNV and no classic CNV.
确定黄斑区散射（“格栅”）激光光凝术与观察相比，对边界不清的黄斑下脉络膜新生血管（CNV）患眼视功能的影响，并为评估一项更大规模的确定性试验的可行性和设计提供初步数据。
随机试点临床试验。
两家三级医疗视网膜转诊机构。
年龄相关性黄斑变性继发黄斑下CNV的有症状个体，荧光素血管造影显示隐匿性CNV且边界不清；允许存在典型CNV，但并非入组研究的必要条件。
从基线到特定时间段的视力变化。
52只眼被分配至观察组。51只眼被随机分配至治疗组，对CNV区域进行黄斑区散射（“格栅”）激光光凝术。其中8只眼的治疗方案还包括对典型CNV区域进行融合性激光光凝术。治疗组从基线开始的平均视力下降幅度大于观察组。两组之间的差异在研究入组后的第一年内最大。在24个月时，每组略多于40%的患眼视力下降了6行或更多。对于最初具有隐匿性CNV血管造影特征但无典型CNV的患眼亚组，也观察到了类似结果。
这些短期研究结果表明，对于年龄相关性黄斑变性中边界不清的有症状黄斑下CNV，与观察相比，黄斑区散射（“格栅”）激光治疗无益处，甚至可能有害。无论是否接受治疗，这些患者中有很大一部分在寻求治疗后的2年内有严重视力丧失的风险，即使患眼最初为隐匿性CNV且无典型CNV。
