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德国Okuvision公司微电流治疗公布结果

德国Okuvision公司在美国举行的ARVO年会上发布了其微电流刺激治疗视网膜色素变性的结果,实验的患者共24个早期和中期患者,具体结果等风之子版主准确翻译以后在发上来。

May 03, 2011 09:00 AM Eastern Daylight Time
Study Demonstrates Electrical Stimulation Therapy Safe and Well-Tolerated in Early Stage Retinitis Pigmentosa Patients
Okuvision GmbH Presents Data from its First Study at the Association for Research in Vision and Ophthalmology Annual Meeting

REUTLINGEN, Germany & FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Okuvision GmbH, an innovator in the field of electrical stimulation therapy (EST) for early and intermediate stage retinitis pigmentosa patients, today announced the presentation of data from the company’s first sham-controlled pilot study at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. The study included 24 patients suffering from early and intermediate stage retinitis pigmentosa who were separated into three groups and received EST at varying strengths for 30 minutes once a week for six weeks. The presentation was delivered by lead author, Dr. Florian Gekeler of the Centre for Ophthalmology, Tuebingen University Eye Hospital, and is one of four Okuvision-related presentations being given at the 2011 ARVO Annual Meeting convening May 1-5 in Fort Lauderdale, Fla.

“Transcorneal Electrical Stimulation in Patients with Retinitis Pigmentosa”
.Dr. Gekeler’s poster presentation titled, “Transcorneal Electrical Stimulation in Patients with Retinitis Pigmentosa,” highlights findings from Okuvision’s first clinical trial which began in 2007 using a thread electrode to stimulate the retina with small amounts of current. Twenty-four patients with early and intermediate stage retinitis pigmentosa were randomized and separated into three different groups. Each group received different levels of stimulation—the first was treated without electrical current, the second with 67 percent of the individual threshold, and the third with 150 percent of the patient’s threshold for 30 minutes a week for six weeks. Final evaluation showed a +20 percent statistically significant improvement in the field of vision by patients who received the 150 percent stimulation. The findings from this study emphasize that electrical stimulation of the retina liberates growth factors which may be able to delay retinal degeneration.

“Our team began this study with the goal of determining whether electrical stimulation therapy could safely and effectively preserve vision for early stage retinitis pigmentosa patients,” said Dr. Florian Gekeler, consultant at the Centre for Ophthalmology of the University of Tuebingen, Germany. “The visual results achieved surpassed our initial expectations and it is our hope that these results will be the first step in ensuring that EST is considered a viable treatment option to slow the degenerative progress for retinitis pigmentosa patients.”

Retinitis pigmentosa (RP) is one of the most common forms of inherited retinal degeneration that grows worse over time. Affecting approximately 300,000 people in the world, this progressive condition typically causes severe vision problems in adulthood, often resulting in complete blindness. While there are no approved treatment options that can slow the onset of RP, this study presents patients with a promise of hope in delaying the degeneration of the eye.

“The results of our study show promise that a treatment option, while not a cure for retinitis pigmentosa, could be available in the future,” said Dr. Walter-G. Wrobel, chairman and founder, Okuvision GmbH. “While much is still unknown about EST technology, the results of the study are a great step toward determining efficacy of this treatment and we look forward to conducting further studies to potentially reach out to those who are hopeful in delaying the effects of retinitis pigmentosa.”

The study findings were also reported online on April 5, 2011 in Investigative Ophthalmology & Visual Science, the official journal of ARVO (www.iovs.org, A.Schatz et.al., IOVS Papers in Press. Published on April 5, 2011 as Manuscript iovs.10-6932).

The Okuvision therapy device is not for sale in the United States.
下由风之子版主翻译

试验表明电刺激疗法可以安全并无痛的治疗早期RP患

在视觉及眼科研究协会(ARVO)的年会上, 相关研究人员对电刺激疗法(EST)治疗早期及中期RP的试验数据进行了说明。电刺激疗法的临床试验招募了24名志愿者,他们患有早期及中期RP。这些志愿者被分为三组,分别接受不同的强度的电刺激治疗,治疗频次为每周治疗30分钟,治疗6个星期。此疗法的首席研究员是德国图宾根大学眼科医院视觉中心的Florian Gekeler博士。

德国Okuvision公司在2007年就开始了临床试验,开始阶段使用小流量电流来刺激视网膜。试验的24名志愿者被随机分为三组,试验为双盲对比试验。第一组志愿者不接受电流治疗;第二组接受的电流强度为百分之67;第三组为百分之150。根据试验结果的统计数据,第三组志愿者的视野提高幅度大于百分之20。试验结果表明电刺激视网膜会释放眼内的增长因子,这些物质可能会延缓视网膜退化。

研究人员表示试验结果超出了他们的期望,

Okuvision公司的总裁说,电刺激疗法虽然不能治愈RP,但此次试验对于判定此疗法对RP 的治疗效果非常有用,我们计划进行更多的试验,以帮助RP患者延缓病情发展。

此次试验结果也在视觉及眼科研究协会(ARVO)的官方期刊《眼科及视觉科学调查》的2011年4月5日上发表。

此治疗设备目前在美国还没有销售。
这个治疗仪一个星期治疗一次视野提高大于20%,如果一天治疗一次不知道效果是否更好。
这篇文章今天已经在世界最权威的视网膜退化病人组织:美国抗盲基金会的网站上发布了,而且这个项目又是美国FDA实验项目,因此这个治疗仪器和治疗方法还是很科学的,值得期待的。

美国抗盲基金会网站报道的文章 http://www.medicalnewstoday.com/articles/224224.php
21# 罗兰德尼奥


已经发邮件和德国联系了,等待回音。
33# 翩跹

在美国不能销售不一定在欧洲不能销售,像另外一个美国出的微电流治疗仪,它在美国不能销售而在欧洲却获得了上市。换句话说,只要在世界上任何国家有卖,基本上我们也能够想办法买到。
36# xinx

谢谢你的分享,你是德国的病友?

这个产品在欧洲卖什么价格,能不能告知?
45# xinx

一个星期用几次,一次用多久?

没有患者使用超过3个月吗?
论坛会先把一些主要的问题发上来,咨询大家的意见,然后由xinx统一回答。
71# YESCHONG

这个产品的FDA安全性、有效性实验是从2008年1月开始的,2010年7月结束的,然后再进行数据收集,因此说现在公布结果还是很正常的。至于为什么只有四个月的实验,FDA有严格的审批程序,也许FDA为了安全只批准了四个月的实验。
FDA数据库关于这个设备实验的资料http://www.clinicaltrials.gov/ct ... kuvision&rank=1
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