Portable electroretinogram screening by an advanced practice nurse for diabetic retinopathy
Official title: Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.
Run by CHU de Reims · NCT06782997 · Data updated 2026-11-12
This project will test whether a portable electroretinogram performed and read by an advanced practice nurse can detect diabetic retinopathy in adults with diabetes who have no known eye disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Status | Recruiting |
| Started | June 17, 2025 |
| Main results expected | December 17, 2026 |
| Study ends | December 17, 2026 |
| Registry record updated | July 28, 2025 |
| Trial ID | NCT06782997 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with type 1 or type 2 diabetes who have no known diabetic retinopathy and are being seen at the participating hospitals in Reims or Charleville-Mézières for diabetes evaluation are ideal candidates.
✕Probably not a fit
Patients with known diabetic retinopathy, recent cataract surgery (<3 months), current pregnancy or within 3 months postpartum, photosensitive epilepsy, those under legal protection, or those unable to attend the participating centers are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, bi-center observational comparison of a portable electroretinogram (ERG) performed and interpreted by an Advanced Practice Nurse (APN) against retinal imaging (retinography) interpreted remotely by an ophthalmologist. Adult patients with type 1 or type 2 diabetes and no known diabetic retinopathy, admitted for diabetes evaluation at two French hospitals, will undergo ERG and standard retinal imaging. The ERG provides a composite DR score (considered abnormal if <7 or >23.4) combining pupillary response, implicit time, and response amplitude to light stimuli, and the study will compare sensitivity and specificity versus imaging. Investigators will analyze whether the APN-run ERG can reliably identify cases needing ophthalmology follow-up and may detect functional changes before imaging abnormalities appear.
Why it matters
Potential benefit: If successful, nurse-run portable ERG screening could increase access to earlier, noninvasive detection of diabetic retinopathy and help get more patients referred to ophthalmology sooner.
How similar studies have gone: Previous work with portable ERG devices has reported roughly 80% sensitivity and 82% specificity versus conventional imaging, indicating promising but not definitive performance, while using APNs to perform and interpret ERG is a newer, less-tested approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 criteria: * Known diabetic retinopathy * Ongoing pregnancy or within 3 months postpartum * Recent cataract surgery (\< 3 months) * Photosensitive epilepsy * Patients under legal protection
Where it's running
-
Damien JOLLY
Reims, France Recruiting
Study contacts
- Study coordinator: Jenny FONTAINE
- Email: jfontaine@chu-reims.fr
- Phone: 03 26 78 80 21
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.