Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of preventable blindness in working-age individuals. Early screening for DR is a public health issue. The gold standard is fundoscopy interpreted by an ophthalmologist. In France, in 2020, it was estimated that one-third of diabetic patients had not seen an ophthalmologist in over two years. Recently, a portable electroretinogram (ERG), which provides a physiological and non-invasive assessment of retinal cell function, has been developed. It combines pupillary responses through an infrared-sensitive camera, the implicit time and the response amplitude to brief white light stimuli. The result is expressed as an overall score (DR score), considered abnormal if it is \< 7 or \> 23.4. The sensitivity of the ERG for screening diabetic retinopathy is estimated at 80%, and its specificity at 82%, compared to conventional imaging. Additionally, it has been shown that poor glycemic control is associated with an increase in implicit time in preclinical DR. This test could therefore detect earlier changes than imaging results. To date, it is not considered the gold standard in France. The investigators aim to test this hypothesis. The investigators propose a prospective, bi-center study to evaluate the performance of the ERG, performed and interpreted by an Advanced Practice Nurse (APN), compared to the gold standard of retinal imaging (retinography) interpreted remotely by an ophthalmologist.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients \> 18 years old

• With type 1 or type 2 diabetes mellitus

• No known diabetic retinopathy

• Affiliated to a social security system

• Attending the hospitals of Reims or Charleville Mézières in France during a hospitalization for the evaluation of their diabetes and complications

Locations
Other Locations
France
Damien JOLLY
RECRUITING
Reims
Contact Information
Primary
Jenny FONTAINE
jfontaine@chu-reims.fr
03 26 78 80 21
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2026-12-17
Participants
Target number of participants: 270
Treatments
diabetic Patients
Any diabetic hospital patient requiring screening for diabetic retinopathy
Related Therapeutic Areas
Sponsors
Leads: CHU de Reims

This content was sourced from clinicaltrials.gov