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

Not yet recruiting

• Conditions: Diabetic Retinopathy

• Registration Number: NCT06782997
• Lead Sponsor: CHU de Reims

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.

Detailed 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.

The investigators' study will prospectively include adult patients with type 1 or type 2 diabetes mellitus and without know DR. These patients are followed in both study centers and both examinations (ERG and retinography) will be performed during the hospitalization for the evaluation of their diabetes and complications. Sensitivity and specificity of the ERG performed and interpreted by an APN will be compared to gold standard.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Study Start: 2025-02-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the electroretinogram	during the patient's hospitalization, an average of 1 week	Sensitivity of the electroretinogram, performed and interpreted by an advanced practice nurse, for screening diabetic retinopathy compared with the gold standard (retinography interpreted by an ophthalmologist).

Secondary Outcome Measures

Name	Time	Method
Specificity, positive predictive value and negative predictive value of the ERG	during the patient's hospitalization, an average of 1 week	Specificity, positive predictive value and negative predictive value of the ERG performed and interpreted by an advanced practice nurse, for screening diabetic retinopathy compared with the gold standard

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France