Portable electroretinogram screening by an advanced practice nurse for diabetic retinopathy
Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.
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 |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT06782997 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Reims
- Damien JOLLY — Reims, France (Recruiting)
Study contacts
- Study coordinator: Jenny FONTAINE
- Email: jfontaine@chu-reims.fr
- Phone: 03 26 78 80 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.