Retinal Function in Diabetic Patients Without Retinopathy

NCT ID: NCT00839150

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-05-31

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Diabetic patients without diabetic retinopathy : No intervention

No interventions assigned to this group

2

Sex and age-matched control subjects : No intervention

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascale Massin, MD,Pr;PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital Lariboisiere

Paris, , France

Countries

France

References

Lecleire-Collet A, Audo I, Aout M, Girmens JF, Sofroni R, Erginay A, Le Gargasson JF, Mohand-Said S, Meas T, Guillausseau PJ, Vicaut E, Paques M, Massin P. Evaluation of retinal function and flicker light-induced retinal vascular response in normotensive patients with diabetes without retinopathy. Invest Ophthalmol Vis Sci. 2011 May 2;52(6):2861-7. doi: 10.1167/iovs.10-5960.

Reference Type: DERIVED

PMID: 21282578 (View on PubMed)

Other Identifiers

P041009

Identifier Type: -

Identifier Source: org_study_id