RecruitingNCT06782997

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


Sponsor

CHU de Reims

Enrollment

270 participants

Start Date

Jun 17, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

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

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Interventions

DEVICEElectroretinogram

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


Locations(1)

Damien JOLLY

Reims, France

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NCT06782997


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