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

NCT05395468 | Unknown

• 2 other identifiers: AOI 2021 LOBBES2021-A03087-34
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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%.

Conditions

Iron-deficiency

Keywords

Iron deficiency; eyes; women

Outcome Measures

Primary Outcomes (1)

• Validate in a real clinical situation (systematic screening for iron deficiency)

  Validate in a real clinical situation (systematic screening for iron deficiency) a tool for predicting ferritin levels based on digital photographs of the ocular sclera, with confrontation of a learning base treated by deep learning, and a test base

  evaluation 15 day after diagnostic

Secondary Outcomes (2)

• To study the informational value of photographic data

  evaluation 15 day after diagnostic

• Identify external factors influencing the quality of the ferritin

  evaluation 15 day after diagnostic

Interventions

photographs of each eye OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women 18 years or older with iron deficiency

You may qualify if:

• Female sex
• Age ≥ 18 years old
• Able to express non-opposition to participation in rese
• Patients affiliated to a social security scheme
• Blood count : value of hemoglobin, mean blood volume
• Serum ferritin

You may not qualify if:

• Personal history of severe trauma or surgery of both eyes (apart from refractive surgery performed more than 3 months ago)
• Personal history of hereditary connective tissue pathology including Marfan's disease, Ehler Danlos syndrome, imperfect osteogenesis.
• Personal history of pathology responsible for chronic hemolysis due to yellow coloration induced by hyperbilirubinemia: sickle cell disease, major thalassemia.
• Prolonged treatment with minocycline (\> 1 month).
• Oral or intravenous martial supplementation started more than 15 days prior to taking the sclera photographs.
• Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
• Pregnant or breastfeeding woman
• Expression of opposition to research.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Université d'Auvergne: collaborator

Study Sites (2)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

SSU Université Clermont Auvergne

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hervé LOBBES

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 473 754 963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 27, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 25, 2022

Record last verified: 2022-05

Locations

FR (2)