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真实世界研究比较糖尿病黄斑水肿中应用地塞米松植入物治疗的有晶状体眼与拟晶状体眼:PHAKIDEX 研究。

REAL WORLD STUDY COMPARING PHAKIC VERSUS PSEUDOPHAKIC EYES IN DIABETIC MACULAR EDEMA TREATED WITH DEXAMETHASONE IMPLANT: The PHAKIDEX Study.

机构信息

Service d'Ophtalmologie, Centre Hospitalier Universitaire de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.

Université Lyon 1, Lyon, France.

出版信息

Retina. 2023 Jul 1;43(7):1088-1096. doi: 10.1097/IAE.0000000000003787.

Abstract

PURPOSE

Dexamethasone implant (DEX-implant) is one treatment choice in diabetic macular edema. However, steroid-induced cataract is a common complication when treating a chronic disease and could lead to vision loss. Because of the lack of studies specifically focused on the functional outcomes according to the lens status, the authors therefore aim to analyze the effectiveness and safety of DEX-implant treatment for diabetic macular edema in phakic versus pseudophakic eyes.

METHODS

This multicenter, retrospective study conducted in France included eyes of consecutive patients who had received a DEX-implant for diabetic macular edema.

RESULTS

A total of 328 eyes were included: 158 eyes (48.2%) were phakic, 167 eyes (50.9%) were pseudophakic and three were unknown. According to the lens status, mean change in best-corrected visual acuity from baseline was never significantly different between phakic and pseudophakic eyes (likelihood ratio test, P = 0.09) nor in the change in central macular thickness (likelihood ratio test, P = 0.79) in multivariate analysis. Cataract surgery was performed in 63 phakic eyes (39.9%) during the study period with a mean delay of 8.1 months (CI95% [6.59-9.69]). The mean change in best-corrected visual acuity between phakic eyes who underwent cataract surgery and those who did not, was not significantly different during the follow-up at each visit. The risk of ocular hypertension was not statistically different between phakic and pseudophakic subsets ( P = 0.9).

CONCLUSION

The authors showed here that phakic eyes treated with DEX-implant for diabetic macular edema did not have a significant difference in visual gain in comparison to pseudophakic eyes, with a comparable safety profile.

摘要

目的

地塞米松植入物(DEX-implant)是治疗糖尿病性黄斑水肿的一种治疗选择。然而,在治疗慢性病时,类固醇引起的白内障是一种常见的并发症,可能导致视力丧失。由于缺乏专门针对晶状体状态的功能结果的研究,作者因此旨在分析在有晶状体眼与无晶状体眼的糖尿病性黄斑水肿患者中,DEX-implant 治疗的有效性和安全性。

方法

本研究为法国多中心回顾性研究,纳入了接受 DEX-implant 治疗糖尿病性黄斑水肿的连续患者的眼。

结果

共纳入 328 只眼:158 只眼(48.2%)为有晶状体眼,167 只眼(50.9%)为无晶状体眼,3 只眼状态未知。根据晶状体状态,最佳矫正视力从基线的平均变化在有晶状体眼和无晶状体眼中从未有显著差异(似然比检验,P=0.09),在多变量分析中,中心黄斑厚度的变化也无显著差异(似然比检验,P=0.79)。在研究期间,63 只有晶状体眼(39.9%)行白内障手术,平均延迟 8.1 个月(95%置信区间[6.59-9.69])。在每次随访期间,行白内障手术与未行白内障手术的有晶状体眼之间的最佳矫正视力平均变化无显著差异。有晶状体眼和无晶状体眼亚组的高血压性眼病风险无统计学差异(P=0.9)。

结论

作者在此表明,与无晶状体眼相比,接受 DEX-implant 治疗糖尿病性黄斑水肿的有晶状体眼在视力增益方面没有显著差异,具有相似的安全性。

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