Skip to content

Design and preliminary clinical validation of an artificial intelligence-driven pupil monitoring system for patients with neurological disorders

Design and preliminary clinical validation of an artificial intelligence-driven pupil monitoring system for patients with neurological disorders

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105504
Enrollment
Unknown
Registered
2025-07-04
Start date
2025-01-08
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of the nervous system

Interventions

Safety Assessment Group:Participants are required to close their eyes while the AI monitoring system starts working to record pupil images. During this period, avoid direct sunlight and external inter
Prospective single-arm self-control Group:The infrared LEDs placed on the temples emit a continuous 0. 1 second of pulsed light
Wait 0.2 sec and use a 1 sec white LED pulse to irradiate the subject's eyes directly from the front

Sponsors

Drum Tower Hospital, The Affiliated to Nanjing University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Part I: No history of eye disease, no recent eye surgery or drug use; 2.Part II: Have certain clinical experience in the medical field (doctors with the title of attending physician or above, and nurses with at least three years of working experience), and have participated in the prototype use of the system or related research projects; be able to express their opinions fluently; sign informed consent form before interview, agree to voluntarily participate and authorize the research team to use the interview content as research data; 3.Part III: Critically ill patients diagnosed with neurological related diseases, such as central nervous system infectious diseases, etc., and required to have a diagnosis certificate from a medical professional; the patient's disease state remained stable in the near future, without acute attacks or significant deterioration trends; participants needed to be able to maintain stable eye closure for at least 5 seconds to ensure effective detection of pupil change devices; patients had no cognitive impairment or communication difficulties; informed consent, voluntary signing of informed consent form;

Exclusion criteria

Exclusion criteria: 1. Patients with severe eye diseases or obvious abnormal pupils in the closed eye, such as poor pupil dilation, fixed and unchanged, etc.; 2. Complications such as discomfort with closed eyes or light sensitivity; 3. Suffering from other serious neurological diseases that may affect pupillary function or cognition, such as Alzheimer's disease, advanced Parkinson's disease, etc.

Design outcomes

Primary

MeasureTime frame
Assess for reactions such as eye discomfort, irritation, or light sensitivity when using the pupil monitoring system;Monitoring accuracy, clinical suitability and safety of the system;

Countries

China

Contacts

Public ContactChen Lu

Drum Tower Hospital, The Affiliated to Nanjing University School of Medicine

gycc2011@126.com+86 15951891930

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026