Vitrectomy with and without encircling band for pseudophakic retinal detachment: VIPER study report No. 4-long-term results.

IF 3.7 2区 医学 Q1 OPHTHALMOLOGY
Sabine Baumgarten, Martin Hellmich, Petra Schiller, Claudia Michalik, Peter Walter
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Abstract

Background: This open-label extension study to the original VIPER trial investigated the long-term single surgery success after repair of an uncomplicated pseudophakic retinal detachment (PRD) by vitrectomy and gas with or without an encircling band (EB).

Methods: Examination data from patients enrolled in the VIPER trial obtained after the 26-weeks' follow-up period (26-weeks' FU) of the original trial were analysed, and failures, given as indications for another reattachment procedure, were documented.

Results: From the original study population of 257 patients enrolled to the three treatment groups (20G vitrectomy+EB (E1), 20G vitrectomy alone (C) and 23/25G vitrectomy (E2)), follow-up data from 105 (41%) patients could be collected. The additional postoperative follow-up was 1.4 months up to 10.8 years. Of the 105 patients enrolled in this long-term analysis, 102 had an observation time greater than 2 years. Failures due to the reattachment procedure within the 26-week FU of the original trial were as follows: 17 in E1, 19 in C and 5 in E2. Additional late failures were found in seven cases: two in E1, three in C and two in E2, respectively.

Conclusions: The long-term observation of additional failures after primary vitrectomy with or without EB did not change the main result of the VIPER study. There is still no evidence that an additional EB would improve the primary surgical success of vitrectomy for uncomplicated PRD. In the cohort of 105 patients with a longer follow-up than 26 weeks, only seven additional failures were observed.

Trial registration number: DKRS00023359.

玻璃体切除术带和不带环治疗假晶状体视网膜脱离:VIPER研究报告第4号-长期结果。
背景:这项开放标签的扩展研究是对原始VIPER试验的研究,研究玻璃体切除术和带或不带环带(EB)的气体修复无并发症的假晶状体视网膜脱离(PRD)后的长期单次手术成功。方法:在原始试验的26周随访期(26周FU)后,对参加VIPER试验的患者的检查数据进行分析,并将失败作为另一次再附着手术的指征记录下来。结果:从纳入三个治疗组(20G玻璃体切除术+EB (E1)、单独20G玻璃体切除术(C)和23/25G玻璃体切除术(E2))的257例患者的原始研究人群中,可收集105例(41%)患者的随访数据。术后额外随访1.4个月至10.8年。在这项长期分析的105名患者中,102名患者的观察时间超过2年。在最初试验的26周FU内,由于再附着手术失败的病例如下:E1 17例,C 19例,E2 5例。另外在7例中发现晚期失败:E1中2例,C中3例,E2中2例。结论:对伴有或不伴有EB的初次玻璃体切除术后额外失败的长期观察并没有改变VIPER研究的主要结果。目前仍没有证据表明额外的EB会提高玻璃体切除术治疗无并发症PRD的原发性手术成功率。在随访时间超过26周的105例患者中,仅观察到7例额外的失败。试验注册号:DKRS00023359。
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来源期刊
CiteScore
10.30
自引率
2.40%
发文量
213
审稿时长
3-6 weeks
期刊介绍: The British Journal of Ophthalmology (BJO) is an international peer-reviewed journal for ophthalmologists and visual science specialists. BJO publishes clinical investigations, clinical observations, and clinically relevant laboratory investigations related to ophthalmology. It also provides major reviews and also publishes manuscripts covering regional issues in a global context.
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