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NCT Number: NCT06782997

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Sensitivity of the electroretinogram

    Time frame: 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 outcomes

  1. Specificity, positive predictive value and negative predictive value of the ERG

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny FONTAINE

CONTACT

[email protected]

03 26 78 80 21 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: ERGDIAB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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