NCT06782997 Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.
| NCT ID | NCT06782997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Reims |
| Condition | Diabetic Retinopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 270 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2026-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 270 participants in total. It began in 2025-06-17 with a primary completion date of 2026-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06782997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Retinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06782997 currently recruiting?
Yes, NCT06782997 is actively recruiting participants. Contact the research team at jfontaine@chu-reims.fr for enrollment information.
Where is the NCT06782997 trial being conducted?
This trial is being conducted at Reims, France.
Who is sponsoring the NCT06782997 clinical trial?
NCT06782997 is sponsored by CHU de Reims. The trial plans to enroll 270 participants.