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NCT Number: NCT04608890

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

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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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sacco University Hospital

Milan, MI, 20157, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Patients:

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

Treatment and study plan

Eye-tracking video test

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.

Primary outcomes

  1. 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

  1. Percentage of patients with a change in eye movement test in the Resistance class

    Time frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months

    Percentage of parameters tested in the Resistance class changed in patients with type 1 diabetes as compared to healthy subjects. Resistance will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Resistance.

  2. Percentage of patients with a change in eye movement test in the Wideness class

    Time frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months

    Percentage of parameters tested in the Wideness class changed in patients with type 1 diabetes as compared to healthy subjects. Wideness will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Wideness.

  3. Percentage of patients with a change in eye movement test in the Velocity class

    Time frame: End of the study (when all patients have completed all sessions of the test), an average of 6 months

    Percentage of parameters tested in the Velocity class changed in patients with type 1 diabetes as compared to healthy subjects. Velocity will be measured by using number of visualization required to recognize a target and time (seconds) required to recognize a target moving on the screen in different directions. An algorithm will attribute those measurements to the specific class of Velocity.

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • ASST Fatebenefratelli Sacco

Registry information

Acronym: EyekonT1D

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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