PDF(Pubmed)
Abstract：
BACKGROUND: Retinitis pigmentosa (RP) is an inherited disease characterized by a progressive loss of rod photoreceptors of the eye, leading to irreversible blindness. To date, to our knowledge, no clinical prospective studies have been undertaken that could document the effect of interventions that could reverse or reduce the progression of this disease. The application of microcurrent stimulation (ES) of the eye in the treatment of chronic eye diseases such as glaucoma and age-related macular degeneration has been used over several decades and has been reported to have beneficial effects to reduce the progression of these blinding diseases and has been supported by animal studies and smaller clinical studies, but to date, no large randomized clinical trials on the use of microcurrent therapy have been published. More recent clinical reports have also shown beneficial effects of ES on slowing the progression of RP but also lacks data from robust prospective clinical outcome studies. To our knowledge, this is the first prospective randomized study to evaluate the safety and clinical effectiveness of transpalpebral electrical stimulation (TpES) on the progression of RP.
METHODS: Randomized prospective study using N-of-1 trial 3 single-blind, crossover comparisons. The intervention period of each comparison is divided into treatment period and control period which are randomized arranged. Twelve participants will be strictly recruited in N-of-1 trial by the researcher in accordance with the inclusion and exclusion criteria. The main outcome of interest examined after each cycle of the 8-week intervention period is the assessment of the visual field (VF). Other variables of interest are best corrected visual acuity (BCVA), retinal function using electroretinogram (ERG), and visual function using NEI VFQ-25 questionnaire. Objective assessments of retinal changes will be undertaken using optical coherence tomography (OCT) and fundus autofluorescence (FAF).
CONCLUSIONS: The trial will evaluate the efficacy and safety of microcurrent stimulation on RP and provide high-quality evidence for clinical application through N-of-1 trial.
BACKGROUND: Chinese Clinical Trial Registry; ChiCTR2300067357; https://www.chictr.org.cn/showproj.html?proj=174635 . Registered on 5 January 2023.
METHODS: Randomized prospective study using N-of-1 trial 3 single-blind, crossover comparisons. The intervention period of each comparison is divided into treatment period and control period which are randomized arranged. Twelve participants will be strictly recruited in N-of-1 trial by the researcher in accordance with the inclusion and exclusion criteria. The main outcome of interest examined after each cycle of the 8-week intervention period is the assessment of the visual field (VF). Other variables of interest are best corrected visual acuity (BCVA), retinal function using electroretinogram (ERG), and visual function using NEI VFQ-25 questionnaire. Objective assessments of retinal changes will be undertaken using optical coherence tomography (OCT) and fundus autofluorescence (FAF).
CONCLUSIONS: The trial will evaluate the efficacy and safety of microcurrent stimulation on RP and provide high-quality evidence for clinical application through N-of-1 trial.
BACKGROUND: Chinese Clinical Trial Registry; ChiCTR2300067357; https://www.chictr.org.cn/showproj.html?proj=174635 . Registered on 5 January 2023.
摘要：
背景：色素性视网膜炎（RP）是一种遗传性疾病，其特征是眼睛的视杆光感受器逐渐丧失，导致不可逆转的失明。迄今为止,根据我们的知识，目前还没有开展临床前瞻性研究,证明干预措施能够逆转或减缓该疾病进展的效果.眼睛微电流刺激（ES）在慢性眼病如青光眼和年龄相关性黄斑变性的治疗中的应用已经使用了几十年，据报道对减少这些致盲疾病的进展具有有益作用，并得到了动物研究和较小的临床研究的支持。但迄今为止,尚未发表关于使用微电流疗法的大型随机临床试验.最近的临床报告也显示了ES对减缓RP进展的有益作用，但也缺乏来自稳健的前瞻性临床结果研究的数据。据我们所知,这是第一项前瞻性随机研究,目的是评估经椎管电刺激(TpES)对RP进展的安全性和临床有效性.
方法：使用N-of-1试验3单盲的随机前瞻性研究，交叉比较。每个比较的干预期分为随机排列的治疗期和对照期。研究人员将根据纳入和排除标准在N-of-1试验中严格招募12名参与者。在8周干预期的每个周期后检查的主要关注结果是视野（VF）的评估。其他感兴趣的变量是最佳矫正视力（BCVA），使用视网膜电图（ERG）的视网膜功能，视觉功能使用NEIVFQ-25问卷。视网膜变化的客观评估将使用光学相干断层扫描（OCT）和眼底自发荧光（FAF）进行。
结论：该试验将通过N-of-1试验评估微电流刺激对RP的疗效和安全性，并为临床应用提供高质量的证据。
背景：中国临床试验注册中心；ChiCTR2300067357；https://www.chictr.org.cn/showproj.html?proj=174635。2023年1月5日注册。
方法：使用N-of-1试验3单盲的随机前瞻性研究，交叉比较。每个比较的干预期分为随机排列的治疗期和对照期。研究人员将根据纳入和排除标准在N-of-1试验中严格招募12名参与者。在8周干预期的每个周期后检查的主要关注结果是视野（VF）的评估。其他感兴趣的变量是最佳矫正视力（BCVA），使用视网膜电图（ERG）的视网膜功能，视觉功能使用NEIVFQ-25问卷。视网膜变化的客观评估将使用光学相干断层扫描（OCT）和眼底自发荧光（FAF）进行。
结论：该试验将通过N-of-1试验评估微电流刺激对RP的疗效和安全性，并为临床应用提供高质量的证据。
背景：中国临床试验注册中心；ChiCTR2300067357；https://www.chictr.org.cn/showproj.html?proj=174635。2023年1月5日注册。
