艾哈迈德对贝弗利特研究：一年治疗结果。
The Ahmed Versus Baerveldt study: one-year treatment outcomes.
机构信息
Department of Ophthalmology and Vision Sciences, University of Toronto, Faculty of Medicine, Toronto, Canada.
出版信息
Ophthalmology. 2011 Nov;118(11):2180-9. doi: 10.1016/j.ophtha.2011.05.004. Epub 2011 Sep 1.
OBJECTIVE
To report the 1-year treatment outcomes of the Ahmed Versus Baerveldt (AVB) Study.
DESIGN
Multicenter randomized clinical trial.
PARTICIPANTS
A total of 238 patients were enrolled in the study, including 124 in the Ahmed group and 114 in the Baerveldt group.
METHODS
Patients aged 18 years or older with uncontrolled glaucoma refractory to medicinal, laser, and surgical therapy were randomized to undergo implantation of an Ahmed-FP7 valve (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA), to be followed for 5 years.
MAIN OUTCOME MEASURES
The primary outcome measure was failure, defined as intraocular pressure (IOP) out of target range (5-18 mmHg with ≥ 20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, additional glaucoma procedures, or loss of light perception. Secondary outcome measures included IOP, medication use, visual acuity, complications, and interventions.
RESULTS
There were no significant differences in baseline ocular or demographic characteristics between the study groups with the exception of sex. Preoperatively, the study group had a mean IOP of 31.4 ± 10.8 mmHg on a mean of 3.1 ± 1.0 glaucoma medications with a median Snellen acuity of 20/100. The cumulative probability of failure a 1-year was 43% in the Ahmed group and 28% in the Baerveldt group (P = 0.02). The mean IOP at 1 year was 16.5 ± 5.3 mmHg in the Ahmed group and 13.6 ± 4.8 mmHg in the Baerveldt group (P < 0.001). The mean number of glaucoma medications required was 1.6 ± 1.3 in the Ahmed group and 1.2 ± 1.3 in the Baerveldt group (P = 0.03). Visual acuity was similar in both groups at all visits in the first year (P = 0.66). In the first year after surgery, there were a similar number of patients who experienced postoperative complications in the 2 groups (45% Ahmed, 54% Baerveldt, P = 0.19), but a greater number of patients in the Baerveldt group required interventions (26% Ahmed vs. 42% Baerveldt, P = 0.009).
CONCLUSIONS
The Baerveldt-350 group had a higher success rate than the Ahmed-FP7 group after 1 year of follow-up, but required a greater number of interventions.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
目的
报告 Ahmed 与 Baerveldt（AVB）研究的 1 年治疗结果。
设计
多中心随机临床试验。
参与者
共有 238 名患者入组研究，其中 Ahmed 组 124 例，Baerveldt 组 114 例。
方法
年龄在 18 岁或以上、经药物、激光和手术治疗后仍无法控制的青光眼患者，随机接受 Ahmed-FP7 阀（New World Medical，Inc.，Rancho Cucamonga，CA）或 Baerveldt-350 植入物（Abbott Medical Optics，Inc.，Santa Ana，CA）植入，随访 5 年。
主要观察指标
主要结局指标为失败，定义为术后 3 个月连续 2 次就诊时眼压（IOP）未达到目标范围（5-18mmHg，与基线相比降低≥20%）、视力威胁性并发症、额外的青光眼手术或光感丧失。次要观察指标包括 IOP、药物使用、视力、并发症和干预措施。
结果
两组患者的眼部或人口统计学特征除性别外无显著差异。术前，研究组平均眼压为 31.4±10.8mmHg，平均使用 3.1±1.0 种降眼压药物，中数视力为 20/100。Ahmed 组和 Baerveldt 组 1 年时的累积失败率分别为 43%和 28%（P=0.02）。Ahmed 组 1 年时平均 IOP 为 16.5±5.3mmHg，Baerveldt 组为 13.6±4.8mmHg（P<0.001）。Ahmed 组平均需要降眼压药物 1.6±1.3 种，Baerveldt 组为 1.2±1.3 种（P=0.03）。两组患者在术后第 1 年的所有随访中视力均相似（P=0.66）。术后第 1 年，两组患者术后并发症发生率相似（Ahmed 组 45%，Baerveldt 组 54%，P=0.19），但 Baerveldt 组需要干预的患者更多（Ahmed 组 26%，Baerveldt 组 42%，P=0.009）。
结论
在 1 年的随访后，Baerveldt-350 组的成功率高于 Ahmed-FP7 组，但需要更多的干预措施。
利益冲突披露
参考文献后可能有专有或商业披露。
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