Retinal Function in Diabetic Patients Without Retinopathy

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

• Registration Number: NCT00839150
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-05
• Primary Completion: 2007-01
• Study Completion: 2007-05
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Status Verified: 2009-06
• Last Update Submitted: 2011-09-16
• Last Update Posted: 2011-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hopital Lariboisiere; 🇫🇷 Paris, France