Tests a nurse-performed eye electrical test for diabetic retinopathy screening
Compares a retinal function test with eye photos in adults with diabetes.
Plain-language title generated from the registry record
Registry title: Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.
Key facts
- Where
- Reims, FranceSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 or type 2 diabetes who do not yet know they have diabetic retinopathy, and who are in hospital in Reims or Charleville Mézières to check their diabetes and its complications.
- Age
- Over 18 years old
- Sex
- All sexes can join
- Disease stage
- Type 1 or type 2 diabetes mellitus with no known diabetic retinopathy
- Earlier treatment
- Cataract surgery in the last 3 months is not allowed.
Main reasons for not taking part
- Known diabetic retinopathy
- Pregnant now or within 3 months after giving birth
- Cataract surgery less than 3 months ago
- Photosensitive epilepsy
- Under legal protection
Read by machine on 12 November 2026.
Where in France
- Damien JOLLYReims, FranceContact: Jenny FONTAINETaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- CHU de Reims
- Trial code
- NCT06782997
- Record updated
- 28 July 2025
- Original description
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.Read full original descriptionShow less
Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.
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.
Inclusion: 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.
Exclusion: Recent cataract surgery (< 3 months); Photosensitive epilepsy; Known diabetic retinopathy; Ongoing pregnancy or within 3 months postpartum; Patients under legal protection.