Single-center, single arm, prospective, pivotal study to evaluate the effect and safety of Human tissue and organ substitute ‘RELUMINO-S’ for those with vision defect among low vision who cannot correct with glasses, contact lenses and surgery

Chung-Ang Univerisity Hospital0 个研究点目标入组 35 人开始时间: 待定最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•1.Patients who are 19 years old or older
•2.Patients with low vision who are thought not to be able to correct with glasses, contact lenses and surgery
•3.Patients with best-corrected visual acuity between 0.48 LogMAR and 1.3 LogMAR in the better eye
•4.Vision has been stable for at least for 3 months before the screening

•1.Patients who experienced intravitreal injection (ex. Anti-VEGF) or laser therapy within 6 months before the first screening
•2.Patients who have disabilities other than low vision
•3.Patients with orbital malformation or dermatological disease, unable to wear device
•4.Alcohol abuse, drug abuse, mental illness, or significant systemic disease
•5.Illiteracy who cannot read Korean

发起方

Chung-Ang Univerisity Hospital