Clinical trial NCT04608890: Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes
Official title: Eye-tracking-based Artificial Intelligence Detects Abnormalities of the Oculomotor System in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Neuropathies
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: ASST Fatebenefratelli Sacco
First posted: 2020-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: N=40 patients with type 1 diabetes on insulin treatment N=40 healthy subjects

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Secondary outcomes:
measure: Percentage of patients with a change in eye movement test in the Resistance class
timeFrame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
measure: Percentage of patients with a change in eye movement test in the Wideness class
timeFrame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
measure: Percentage of patients with a change in eye movement test in the Velocity class
timeFrame: End of the study (when all patients have completed all sessions of the test), an average of 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Sacco University Hospital
state: MI
Study officials:
References:
citation: D'Addio F, Pastore I, Loretelli C, Valderrama-Vasquez A, Usuelli V, Assi E, Mameli C, Macedoni M, Maestroni A, Rossi A, Lunati ME, Morpurgo PS, Gandolfi A, Montefusco L, Bolla AM, Ben Nasr M, Di Maggio S, Melzi L, Staurenghi G, Secchi A, Bianchi Marzoli S, Zuccotti G, Fiorina P. Abnormalities of the oculomotor function in type 1 diabetes and diabetic neuropathy. Acta Diabetol. 2022 Sep;59(9):1157-1167. doi: 10.1007/s00592-022-01911-1. Epub 2022 Jun 22.