First-in-Human Trial of a Novel Suprachoroidal Retinal Prosthesis

Retinal visual prostheses (“bionic eyes”) have the potential to restore vision to blind or profoundly vision-impaired patients. The medical bionic technology used to design, manufacture and implant such prostheses is still in its relative infancy, with various technologies and surgical approaches being evaluated. We hypothesised that a suprachoroidal implant location (between the sclera and choroid of the eye) would provide significant surgical and safety benefits for patients, allowing them to maintain preoperative residual vision as well as gaining prosthetic vision input from the device. This report details the first-in-human Phase 1 trial to investigate the use of retinal implants in the suprachoroidal space in three human subjects with end-stage retinitis pigmentosa. The success of the suprachoroidal surgical approach and its associated safety benefits, coupled with twelve-month post-operative efficacy data, holds promise for the field of vision restoration.Trial RegistrationClinicaltrials.gov NCT01603576视网膜视觉假体（俗称“仿生眼”）具备为失明或重度视力受损患者恢复视力的潜力。用于设计、制造及植入此类假体的医用仿生技术，目前尚处于相对早期的发展阶段，多种技术路径与手术方案仍在评估中。本研究假设，将假体植入脉络膜上腔（眼球巩膜与脉络膜之间的间隙），可为患者带来显著的手术与安全获益，使其既能保留术前残余视力，又可通过该设备获得假体视觉输入。本报告详述了针对3名晚期色素性视网膜炎患者开展的首次人体I期临床试验，该试验旨在评估视网膜假体植入脉络膜上腔的应用效果。脉络膜上腔手术路径的成功实施及其附带的安全获益，结合术后12个月的疗效数据，为视力修复领域带来了可期的发展前景。试验注册：ClinicalTrials.gov NCT01603576