Patients undergoing orbital or cranial surgery
Conditions
Interventions
Gold Standard:Pupil shape and diameter are calculated using preoperative corneal horizontal diameter measurements as a reference scale, based on images of both pupils captured by a camera.
Index test:Novel Smart Contact Lens [Pupil Monitoring Device Based on Infrared Reflection Principle]
Sponsors
The Third Medical Center of the General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients undergoing orbital or cranio-cerebral surgery; 2.Administered under general anesthesia; 3.Voluntarily participating in this clinical trial.
Exclusion criteria
Exclusion criteria: 1.Patients with corneal ulcers; 2.Patients with corneal leukoma affecting pupil observation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of the smart contact lens in detecting abnormal changes in pupil diameter;Specificity of the Smart Contact Lens in Detecting Abnormal Pupil Diameter Changes;AUC-ROC Value of the Smart Contact Lens Diagnostic Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive Predictive Value ;Negative Predictive Value;Positivity Rate of Corneal Fluorescein Staining at 24 Hours Postoperatively; | — |
Countries
China
Contacts
Public ContactWu Wei
The Third Medical Center of the General Hospital of the People's Liberation Army
Outcome results
None listed