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曲安奈德诱导的糖尿病黄斑水肿眼白内障:一项随机临床试验的 3 年前瞻性数据。

Triamcinolone-induced cataract in eyes with diabetic macular oedema: 3-year prospective data from a randomized clinical trial.

机构信息

Department of Clinical Ophthalmology, Save Sight Institute, University of Sydney, Sydney, New South Wales, Australia.

出版信息

Clin Exp Ophthalmol. 2010 Aug;38(6):605-12. doi: 10.1111/j.1442-9071.2010.02341.x. Epub 2010 May 27.

DOI:10.1111/j.1442-9071.2010.02341.x
PMID:20528977
Abstract

PURPOSE

To describe the 3-year risk of cataract after intravitreal triamcinolone (IVTA) injections for diabetic macular oedema and the outcomes of cataract surgery.

METHODS

Prospective data from a randomized clinical trial were analysed. At baseline, 27 phakic eyes with diabetic macular oedema were randomized to receive IVTA and 25 to receive sham injection. After 2 years, initial sham-treated eyes were eligible to receive IVTA as the study became open label for the third year. The cumulative incidence of cataract surgery was the primary outcome of the study. Other outcomes assessed included progression of cataract, best-corrected logarithm of the minimal angle of resolution visual acuity before and after surgery and central macular thickness.

RESULTS

Over the 3 years of the study, 15/27 (56%) phakic eyes in the IVTA treated group underwent cataract surgery as compared with 2/25 (8%) initial sham-treated eyes (P < 0.001). Mean visual acuity 6 months after cataract surgery was better than at entry into the trial. Two (15%) of the eyes in the IVTA-treated group undergoing cataract surgery had a loss of >15 letters. In the IVTA-treated group, 10/15 (67%) eyes that had three or more injections had progression of posterior subcapsular cataract by > or = 2 grades as compared with only 2/12 (17%) eyes that had fewer than three injections (P = 0.009).

CONCLUSIONS

Over half of the eyes receiving IVTA injections for diabetic macular oedema required cataract surgery within 3 years. In eyes with three or more IVTA injections, two-thirds had progression of posterior subcapsular cataract. Visual outcomes after cataract surgery were generally good, although a small proportion of eyes lost greater than 15 letters over the course of the study.

摘要

目的

描述玻璃体内曲安奈德(IVTA)注射治疗糖尿病性黄斑水肿后 3 年内白内障的风险,以及白内障手术的结果。

方法

对一项随机临床试验的前瞻性数据进行分析。在基线时,27 例伴有糖尿病性黄斑水肿的非白内障眼随机接受 IVTA 注射,25 例接受假注射。2 年后,初始假治疗眼有资格在第 3 年接受 IVTA 治疗,因为该研究成为开放标签。研究的主要结局是白内障手术的累积发生率。评估的其他结局包括白内障的进展、手术前后最佳矫正对数最小角分辨率视力和中央黄斑厚度。

结果

在研究的 3 年中,27 例接受 IVTA 治疗的非白内障眼中有 15 眼(56%)接受了白内障手术,而初始接受假治疗的 25 例眼中有 2 眼(8%)(P < 0.001)。白内障手术后 6 个月的平均视力优于进入试验时的视力。在接受 IVTA 治疗并接受白内障手术的 2 眼中,有 15%(2 眼)视力丧失超过 15 个字母。在接受 IVTA 治疗的组中,10/15(67%)接受 3 次或更多次注射的眼后囊下白内障进展超过 2 级,而仅 2/12(17%)接受少于 3 次注射的眼有进展(P = 0.009)。

结论

接受 IVTA 注射治疗糖尿病性黄斑水肿的眼在 3 年内有一半以上需要白内障手术。在接受 3 次或更多次 IVTA 注射的眼中,三分之二的眼后囊下白内障进展。白内障手术后的视力结果总体良好,尽管在研究过程中,少数眼视力丧失超过 15 个字母。

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