[Controlled clinical trial of the effect of aspirin and aspirin + dipyridamole on the development of diabetic retinopathy. II. Ophthalmologic protocol].
A description is given of the ophthalmological protocol of the DAMAD (aspirin and dipyridamole + Aspirin) controlled clinical trial in diabetic retinopathy. The 450 patients included in this trial were insulin or noninsulin treated diabetics with an early diabetic retinopathy (i.e. at least five microaneurysms in the posterior pole and/or one zone of capillary non-perfusion). They were randomized in a double blind fashion to treatment with either placebo or aspirin 330 mg or aspirin 330 mg + dipyridamole 75 mg three times daily. A full ophthalmologic examination was performed annually on both eyes of each patient and followed at least three years. Data were recorded on a special form. The main assessment criteria were orientated toward the quantification of the retinal vascular micro-abnormalities, counting of microaneurysm and measurement of the central and peripheral avascular zones. Angiofluorographic photographs were standardized. The two eyes were photographed but only one reference eye was kept for the whole length of this study. A standard reading technique is now used by a technician in charge of coding the quality of the films, the dotting and numbering of the lesions.
D001241:Aspirin / Q000008:administration & dosage* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy*; D004176:Dipyridamole / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005451:Fluorescein Angiography; D006801:Humans
D004176:Dipyridamole; D001241:Aspirin
Essai contrôlé de l'aspirine et de l'association aspirine + dipyridamole sur l'évolution de la rétinopathie diabétique. II. Protocole ophtalmologique.