Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Neuropathies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Long-standing T1D patients

Patients with long-standing type 1 diabetes

Eye-tracking video test

Intervention Type DIAGNOSTIC_TEST

An eye-tracking-based test will be administered to patients. It lasts 10 minutes. It consists in several screens passing by to identify objects at a certain time by a mouse clic or touchpad.

Healthy volunteers

Eye-tracking video test

Intervention Type DIAGNOSTIC_TEST

An eye-tracking-based test will be administered to patients. It lasts 10 minutes. It consists in several screens passing by to identify objects at a certain time by a mouse clic or touchpad.

Interventions

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Eye-tracking video test

An eye-tracking-based test will be administered to patients. It lasts 10 minutes. It consists in several screens passing by to identify objects at a certain time by a mouse clic or touchpad.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes
* willing to give consent

* willing to give consent

Exclusion Criteria

* Diabetic retinopathy and other ocular diseases
* other endocrine disease
* malignancy

Healthy volunteers:

* Other ocular diseases
* Any endocrine disease
* Malignancy

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No