Retinal Function in Diabetic Patients Without Retinopathy

The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy pathogenesis.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Lariboisiere

Paris, 75010, France

About this study

Type 1 and type 2 diabetic patients with no diabetic retinopathy and no hypertension were compared with sex and age-matched control subjects. Color vision was tested with the desaturated LANTHONY 15-Hue test. Contrast sensitivity was assessed with the Pelli-Robson contrast sensitivity test. Pattern-electroretinogram, Ganzfeld full-field electroretinogram and multifocal electroretinogram were recorded according to the International Society for Clinical Electrophysiology of Vision (ISCEV). Flicker-induced vasodilatation in retinal arteries and veins was assessed using the Dynamic Vessel Analyzer.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For diabetic patients :

age between 20 and 55
type 1 or type 2 diabetes mellitus
diabetes duration of more than 5 years
no diabetic retinopathy on fundus examination or fundus photographs
For control subjects :

sex and age matching with the diabetic patients
no diabetes, no familial or personal history of elevated blood sugar

Exclusion criteria

*For both diabetic patients and control subjects :

presence of cataract or history of cataract surgery
intraocular pressure of more than 21 mmHg
abnormal score on the Ishihara test
other ocular disease
ametropia more than 3 diopters, anisometropia more than 1 diopter, astigmatism more than 1 diopter
systemic hypertension (defined as systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
treatment with vasoactive drugs
tobacco consumption of more than 20 cigarettes a day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy

Acronym: NEURODIAB

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Feb 9, 2009
Registry last updated: Sep 19, 2011

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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