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

NCT06782997 | Recruiting

• 1 other identifier: PR25001
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

Diabetes mellitus; electroretinography; screening; diabetic retinopathy; advanced practice nurse

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the electroretinogram

  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).

  during the patient's hospitalization, an average of 1 week

Secondary Outcomes (1)

• Specificity, positive predictive value and negative predictive value of the ERG

  during the patient's hospitalization, an average of 1 week

Study Arms (1)

diabetic Patients

Any diabetic hospital patient requiring screening for diabetic retinopathy

Device: Electroretinogram

Interventions

Electroretinogram DEVICE

Electroretinogram (RETevalTM devices, LKC Technologies) performed and interpreted by an advanced practice nurse compared to the gold standard (retinography) interpreted by an ophthalmologist

diabetic Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 1 or type 2 diabetes mellitus and without know DR, followed in both study centers and hospitalized for the evaluation of their diabetes and complications.

You may qualify if:

• 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

You may not qualify if:

• Known diabetic retinopathy
• Ongoing pregnancy or within 3 months postpartum
• Recent cataract surgery (\< 3 months)
• Photosensitive epilepsy
• Patients under legal protection

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Interventions

Electroretinography

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Jenny FONTAINE

CONTACT

03 26 78 80 21; jfontaine@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 20, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

FR (1)