Retinal Function in Diabetic Patients Without Retinopathy (NEURODIAB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00839150
First received: February 6, 2009
Last updated: September 16, 2011
Last verified: June 2009
  Purpose

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
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Enrollment: 56
Study Start Date: May 2005
Study Completion Date: May 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Diabetic patients without diabetic retinopathy : No intervention
2
Sex and age-matched control subjects : No intervention

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: February 6, 2009
Last Updated: September 16, 2011
Health Authority: France: Ministry of Health

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 1
Diabetes Mellitus, Type 2
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014