JPRN-jRCT2032210094进行中（未招募）3 期
Evaluation of the efficacy and safety of transdermal electrical stimulation on visual functions of patients with retinitis pigmentosa - ePICO trial
Miura Gen0 个研究点目标入组 50 人开始时间: 2021年5月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •Criteria 2 to 4 are applied to an eligible eye.
- •1. Clinically diagnosed with typical retinal pigmentosa and age >/=20-years and <80-years.
- •2. HFA 10-2 performed with reliability fixation defective rate <20%, false positive rate <15%, false negative rate <33%.
- •3. Decimal visual acuity from 0.1 to 0.7.
- •4. HFA 10-2 MD values less than -10 dB.
- •5. Patients who signed consent document with sufficient understanding after receiving explanation for the responsibilities of participating in this trial.
- •6. Regular hospital visits every 2 weeks for 24 weeks and follow up at Weeks 36 and 48.
- •7. Patients who can take appropriate contraceptive measures during the trial period.
排除标准
- •1. Patients who have received electrical stimulation treatment for ocular diseases in the past.
- •2. Patients who underwent intraocular surgery within 3 months of the beginning of this trial.
- •3. Patients who changed the dose and usage of isopropyl unoprostone, calcium antagonist, and helenien within 31 days before the screening examination.
- •4. History of allergy to mydriatic agents and ophthalmic surface anesthetic.
- •5. Presence of ocular diseases such as vitreous macular traction syndrome, macular edema, epiretinal membrane, myopia with posterior staphyloma, diabetic retinopathy, inflammation or infection of accessory visual structures, severe dry eye, central retinal vein occlusion, ischemic optic neuropathy, optic nerve disease, grade 3 or higher Emery-Little grade cataract or posterior capsular opacification.
- •6. Patients who had not experienced any deterioration in the visual acuity, OCT findings, Goldmann perimetry findings, and HFA 10-2 visual field sensitivities in the last 3 years.
- •7. Patients with a pacemaker or defibrillator
- •8. Patients with a history of malignant tumor. However, patients who have not relapsed for more than 5 years can be enrolled.
- •9. 9. Patients diagnosed and treated for psychosis, dementia or mental symptoms.
- •10. Diabetic patients with poor glycemic control (HbA1c (NGSP)> 10.0%).
- •11. Patients with hypertension (systole > 180 mmHg and / or diastole > 110 mmHg) who have difficulty controlling blood pressure by treatment.
- •12. Patients with hepatic or renal dysfunction that meets any of the following at the time of screening.
- •AST, ALT: More than 3 times the upper limit of the facility standard value
- •Creatinine: More than 1.5 times the upper limit of the facility standard value
- •13. Patients who were pregnant, breastfeeding, may be or planned to be pregnant during the trial period.
- •14. Patients participating in other clinical trials.
- •15. Patients under investigational responsibility principal or sub investigator judged inappropriate for participation in this trial.
研究者
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