Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608890
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2020-10-08
Brief Title:
Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EyekonT1D
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None