BCIwiki (bciwiki.com) — Beijing Tongren Hospital, Capital Medical University has registered an observational study of clinical needs for an invasive visual brain-computer interface with the Chinese Clinical Trial Registry, under registration number ChiCTR2600127582, dated July 2, 2026. The study plans to enroll 50 participants, with a first enrolment date of July 13, 2026, and its recruitment status is not yet recruiting. It uses an observational, sequential design with no intervention and is self-funded.
The study involves no implantation and does not evaluate device performance. According to the registration, its primary outcome is research and analysis of product demand related to the realization of visual functions. Secondary outcomes cover demographic and economic characteristics, the influence of quality of life, clinical features, the degree of demand for existing assistive devices, and product requirements related to the design of invasive visual brain-computer interfaces. The condition under study is blind eyes, the recruiting country is China, and there is no gender restriction.
Inclusion criteria require participants to be at least 18 years old, confirmed as first-level blind patients with only weak or no light perception remaining in both eyes, with acquired blindness, and to possess certain cognitive abilities, be capable of effective communication and interaction, and voluntarily sign the informed consent form. Exclusion criteria include a history of mental illness, severe cognitive or communication impairments, congenital blindness, a vision condition that does not meet the criteria for the level one visual impairment group, vision impairment in one eye, and refusal to sign the informed consent form.
The registration page contains only bibliographic and design fields, with no results data, and does not list a specific device model or the actual number of participants enrolled. The record was last updated on July 13, 2026.