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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Endocrine System Diseases
Eye Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014