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Retinal Function in Diabetic Patients Without Retinopathy (NEURODIAB)

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ClinicalTrials.gov Identifier: NCT00839150
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : September 19, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy
Study Start Date : May 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Diabetic patients without diabetic retinopathy : No intervention
2
Sex and age-matched control subjects : No intervention




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839150


Locations
France
Hopital Lariboisiere
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Pascale Massin, MD,Pr;PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00839150     History of Changes
Other Study ID Numbers: P041009
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: June 2009

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetic retinopathy
Color vision
Contrast sensitivity
Electroretinogram
Flicker-induced vasodilatation
Dynamic Vessel Analyzer

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Retinal Diseases
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases