Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milan
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Percentage of patients with a change in eye movement test in each class Resistance, Velocity, Pursuit, Wideness and OKN measured by the eye-tracking based test
Study Overview
Brief Summary
Abnormalities of the oculomotor system may represent an early sign of diabetic neuropathy and are currently poorly studied. The investigators designed an eye-tracking-based test to evaluate the oculomotor function in patients with type 1 diabetes.
The investigators used the SRLab -Tobii TX300 Eye tracker®, an eye-tracking device, coupled with a software that we developed to test abnormalities of the oculomotor system. The software consists in a series of screens divided in 5 classes of parameters (Resistance, Wideness, Pursuit, Velocity and Optokinetic Nystagmus [OKN]) to evaluate both smooth and saccadic movement in different directions. 40 healthy volunteers and 40 patients with long-standing type 1 diabetes will be enrolled to analyze the alterations in the oculomotor system and function.
Detailed Description
The study will enroll 40 healthy volunteers and 40 patients with long-standing type 1 diabetes. The aim of the study is to analyze alterations in the oculomotor system function as an early sign of diabetic neuropathy. A novel eye-tracking-based test will be employed and 5 parameters will be analyzed through the use of a computer-based test which will record timeframes of eye movements towards an object, type of eye movements, time between the first eye movement, number of visualization required to recognize the object across the screen. Each of these parameter will be employed to assess whether Resistance, Wideness, Pursuit, Velocity of eye movements and movements related to the Optokinetic Nystagmus are altered in type 1 diabetes as compared to non diabetic subjects.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 16 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 diabetes
- •willing to give consent
Exclusion Criteria
- •Diabetic retinopathy and other ocular diseases
- •other endocrine disease
- •malignancy
- •Healthy volunteers:
- •Inclusion Criteria:
- •willing to give consent
- •Exclusion Criteria:
- •Other ocular diseases
- •Any endocrine disease
- •Malignancy
Outcomes
Primary Outcomes
Percentage of patients with a change in eye movement test in each class Resistance, Velocity, Pursuit, Wideness and OKN measured by the eye-tracking based test
Time Frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Percentage of all parameters tested in each class changed in patients with type 1 diabetes as compared to healthy subjects. Parameters evaluated include number of visualization required to recognize a target and time (seconds), to recognize a target moving on the screen in different directions.
Secondary Outcomes
- Percentage of patients with a change in eye movement test in the Resistance class(End of the study (when all patients have completed all sessions of the test), an average of 6 months)
- Percentage of patients with a change in eye movement test in the Wideness class(End of the study (when all patients have completed all sessions of the test), an average of 6 months)
- Percentage of patients with a change in eye movement test in the Velocity class(End of the study (when all patients have completed all sessions of the test), an average of 6 months)
Investigators
Paolo Fiorina, MD
Associate Professor of Endocrinology
University of Milan