Randomized trial of peribulbar triamcinolone acetonide with and without focal photocoagulation for mild diabetic macular edema - A pilot study
Randomized trial of peribulbar triamcinolone acetonide with and without focal photocoagulation for mild diabetic macular edema - A pilot study
复制标题
DOI：
10.1016/j.ophtha.2007.02.010
复制
发表时间：
2007-06-01
期刊：
影响因子：
13.7
通讯作者：
Miskala, Paivi H.
中科院分区：
文献类型：
--
作者：
Chew, E.;Strauber, S.;Miskala, Paivi H.
目的：提供前、后眼球筋膜下注射曲安奈德单独或联合局部光凝治疗轻度糖尿病黄斑水肿 (DME) 的安全性和有效性的初步数据。设计：前瞻性、II 期、多中心、随机临床试验。参与者：109 名患有轻度 DIME 且视力为 20/40 或更好的患者（129 只眼）。方法：参与者被随机分配接受局灶性黄斑水肿（DME）治疗。光凝术（n = 38），20 mg 前Tenon 下注射曲安西龙（n = 23），20 mg 前Tenon 下注射，4 周后局部光凝（n = 25），40 mg 后Tenon 下注射曲安西龙（n = 21），或 40 mg 后Tenon 下注射，4 周后局部光凝4 周（n = 22）。在第 4、8、17 和 34 周进行随访。 主要结果指标：用光学相干断层扫描 (OCT) 测量视力和视网膜厚度的变化。结果：在基线时，研究眼睛的平均视力为 20/25，平均 OCT 中心子区域厚度为 328 μm。 34 周时，5 组的视网膜增厚和视力变化没有显着差异（分别为 P = 0.46 和 P = 0.94）。有人建议，当球周曲安西龙与局部光凝相结合时，第 17 周时，更大比例的眼睛中央子视野厚度小于 250 μm。眼内压升高和上睑下垂是注射引起的不良反应。结论：对于视力良好的 DIME 病例，球周曲安西龙，无论是否进行局部光凝治疗，都不太可能产生实质性益处。根据这些结果，没有必要进行 III 期试验来评估这些治疗对轻度 DME 的益处。
Objective: To provide pilot data on the safety and efficacy of anterior and posterior sub-Tenon injections of triamcinolone either alone or in combination with focal photocoagulation in the treatment of mild diabetic macular edema (DME).Design: Prospective, phase II, multicenter, randomized clinical trial.Participants: One hundred nine patients (129 eyes) with mild DIME and visual acuity 20/40 or better.Methods: The participants were assigned randomly to receive either focal photocoagulation (n = 38), a 20-mg anterior sub-Tenon injection of triamcinolone (n = 23), a 20-mg anterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 25), a 40-mg posterior sub-Tenon injection of triamcinolone (n = 21), or a 40-mg posterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 22). Follow-up visits were performed at 4, 8, 17, and 34 weeks.Main Outcome Measures: Change in visual acuity and retinal thickness measured with optical coherence tomography (OCT).Results: At baseline, mean visual acuity in the study eyes was 20/25 and mean OCT central subfield thickness was 328 mu m. Changes in retinal thickening and in visual acuity were not significantly different among the 5 groups at 34 weeks (P = 0.46 and P = 0.94, respectively). There was a suggestion of a greater proportion of eyes having a central subfield thickness less than 250 mu m at 17 weeks when the peribulbar triamcinolone was combined with focal photocoagulation. Elevated intraocular pressure and ptosis were adverse effects attributable to the injections.Conclusions: In cases of DIME with good visual acuity, peribulbar triamcinolone, with or without focal photocoagulation, is unlikely to be of substantial benefit. Based on these results, a phase III trial to evaluate the benefit of these treatments for mild DME is not warranted.