Clinical trial NCT00839150: Retinal Function in Diabetic Patients Without Retinopathy
Official title: Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: Diabetic retinopathy
Color vision
Contrast sensitivity
Electroretinogram
Flicker-induced vasodilatation
Dynamic Vessel Analyzer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pascale Massin, MD,Pr;PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.