NCT05395468

Diagnosis of Iron Deficiency by Artificial Intelligence Analysis of Eye Photography.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of our work is to predict the value of ferritin from the eye, thus constituting an original, non-invasive diagnostic method of iron deficiency. To be usable in real life, the algorithm must be comparable to the performance of the reference diagnostic test (determination of ferritin), allowing to obtain a sensitivity of about 90% and a specificity \> 95%.

Detailed description

Currently, the diagnosis of iron deficiency is invasive, as it requires a venous puncture for serum ferritin assay and blood count analysis to diagnose iron deficiency anemia. This dosage is expensive and represents a major brake in the large-scale screening of iron deficiency, especially in developing countries. Most of the clinical signs of iron deficiency (asthenia, cheilitis, glossitis, alopecia, restless legs syndrome) are not very specific and the diagnosis is most often fortuitous or carried out as part of screening in a population at risk. Iron is essential for many functions of the body, including the synthesis of collagen: in case of deficiency, it is produced with an altered and finer structure. In the eyes, the sclera consists of collagen type IV, whose thinning causes the visualization of the choroidal vessels responsible for a characteristic blue tint. A preliminary work carried out by our team made it possible to measure the increase in the amount of blue color in the sclera of deficient patients, objectifying this clinical sign for the first time. From photographs of patients' eyes, we extracted the percentile of blue contained in the pixels of the digital images of the sclera. This work continued with the automation of the recognition of eye structures, especially the sclera. In order to improve the diagnostic performance of this original and non-invasive method, we want to apply deep-learning methods, which have already been proven in several areas: related to ophthalmology but also in a very encouraging way in the non-invasive diagnosis of anemia. The objective of our work is to predict the value of ferritin from the eye, thus constituting an original, non-invasive diagnostic method of iron deficiency. To be usable in real life, the algorithm must be comparable to the performance of the reference diagnostic test (determination of ferritin), allowing to obtain a sensitivity of about 90% and a specificity \> 95%.

Conditions

• Iron-deficiency

Interventions

Type	Name	Description
OTHER	photographs of each eye	All subjects included will take 5 photographs of each eye according to a standardised procedure in terms of distance, lighting and framing

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2022-05-27
• Last updated: 2022-07-25

Locations

2 sites across 1 country: France