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A multicenter, full crossover, controlled study evaluating the effectiveness and safety of the Auto ONSD+ and Auto Pupil assisted analysis functions

A multicenter, full crossover, controlled study evaluating the effectiveness and safety of the Auto ONSD+ and Auto Pupil assisted analysis functions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107222
Enrollment
Unknown
Registered
2025-08-06
Start date
2024-08-28
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

unlimited

Interventions

golden standard:The expert group used the measurement results of optic nerve sheath diameter and pupil without using Auto ONSD+ or Auto Pupil as the gold standard.
Group A (the experimental group proceeds first):The film reader completes the identification of the best frame of the optic nerve In the first stage, the readers completed the identification of the be
after a certain washout period (= 4 weeks), in the second stage, they completed the identification of the best frames of the ultrasound imaging samples without the assistance of Auto ONSD+ and Auto Pu
Group B (the control group proceeds first):In the first stage, the readers completed the identification of the best frames of the ultrasound image samples without the use of Auto ONSD+ and Auto Pupil
experimental group:Measure the optic nerve sheath diameter and pupil size with the assistance of Auto ONSD+ and Auto Pupil.

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Agree to participate in this study and sign the informed consent form; 2. Age >= 18 years old, gender not restricted; 3. Patients who plan or are willing to undergo pupil examination or intracranial pressure assessment.

Exclusion criteria

Exclusion criteria: 1. Patients with severe trauma to the eyeball, eye socket and eye appendages that affect the detection by the ultrasound probe; 2. Those with a clinical diagnosis or a history of optic neuritis, optic nerve tumors, congenital optic nerve disorders, glaucoma, or cataracts; 3. Those whose clinical assessment indicates a high risk of retinal detachment; 4. Patients wearing artificial eyes; 5. Those participating in other clinical studies; 6. Patients judged by the researchers to be unsuitable for this clinical trial.

Design outcomes

Secondary

MeasureTime frame
Delta;average constriction velocity;Image quality pass rate;

Primary

MeasureTime frame
Accuracy rate of optimal frame image recognition of optic nerve sheath;Accuracy rate of pupil image recognition in the best frame;optic nerve sheath diameter;initial diameter;end diameter of constriction;

Countries

China

Contacts

Public ContactDuan Jun

China-Japan Friendship Hospital

13691362130@163.com+86 136 9136 2130

Outcome results

None listed

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