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玻璃体后皮质切除术联合内界膜剥除术治疗初治糖尿病性黄斑水肿:一项前瞻性、非对照性试点研究。

Pars Plana Vitrectomy with Internal Limiting Membrane Peeling for Treatment-Naïve Diabetic Macular Edema: A Prospective, Uncontrolled Pilot Study.

作者信息

Rush Ryan B, Rush Sloan W

机构信息

Instituto de la Visión- Hospital La Carlota, Montemorelos, Nuevo León, 67530, México.

Panhandle Eye Group, Amarillo, TX, 79106, USA.

出版信息

Clin Ophthalmol. 2021 Jun 21;15:2619-2624. doi: 10.2147/OPTH.S320214. eCollection 2021.

Abstract

PURPOSE

To report the outcomes in subjects undergoing pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling for the management of treatment-naïve diabetic macular edema (DME).

METHODS

Ten treatment-naïve subjects with non-proliferative diabetic retinopathy prospectively underwent PPV with ILM peeling for the treatment of DME at a single university-affiliated institution. The preoperative features, intraoperative details and postoperative outcomes were collected and analyzed.

RESULTS

All 10 subjects underwent PPV with ILM peeling without significant intraoperative or postoperative complications at 6 months follow-up. Visual acuity improved from a baseline of 0.74 (95% CI: 0.48-1.0) logMAR (Snellen 20/110) to 0.46 (95% CI: 0.3-0.62) logMAR (Snellen 20/58) at 6 months follow-up (p=0.045). Optical coherence tomography central macular thickness reduced from a baseline of 456 (95% CI: 394.7-516.4) microns to 316.8 (95% CI: 275.9-357.7) microns at 6 months follow-up (p < 0.001).

CONCLUSION

This pilot study suggests that PPV with ILM peeling may be a viable treatment option for the management of treatment naïve DME in subjects with non-proliferative diabetic retinopathy. Development of a randomized controlled trial may be justified to validate the results of this study.

CLINICALTRIALSGOV IDENTIFIER #: NCT03660345.

摘要

目的

报告初治糖尿病性黄斑水肿(DME)患者接受玻璃体切割联合内界膜(ILM)剥除术的治疗效果。

方法

在一所大学附属医院,10例初治非增殖性糖尿病视网膜病变患者前瞻性地接受了玻璃体切割联合ILM剥除术治疗DME。收集并分析术前特征、术中细节和术后结果。

结果

所有10例患者均接受了玻璃体切割联合ILM剥除术,术后6个月随访时无明显术中或术后并发症。随访6个月时,视力从基线的0.74(95%CI:0.48 - 1.0)logMAR(Snellen 20/110)提高到0.46(95%CI:0.3 - 0.62)logMAR(Snellen 20/58)(p = 0.045)。光学相干断层扫描测量的黄斑中心厚度从基线的456(95%CI:394.7 - 516.4)微米降至随访6个月时的316.8(95%CI:275.9 - 357.7)微米(p < 0.001)。

结论

这项初步研究表明,玻璃体切割联合ILM剥除术可能是治疗初治非增殖性糖尿病视网膜病变DME患者的一种可行治疗选择。开展一项随机对照试验以验证本研究结果可能是合理的。

临床试验注册号

NCT⁃03660345。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf92/8232852/850dbf76b8cf/OPTH-15-2619-g0001.jpg

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