Abstract
Purpose: :
Angioprotective action of lutein and DHA was previously detected on diabetic patients, in which we obtained better retinal performances.The purpose of the study was to evaluate if drug association of lutein and DHA capsules may improve retinal microcirculation causing better performances in a group of diabetics patients.
Methods: :
The study was conducted in double masked conditions. Randomized selection criteria were used to administer pharmaceutical preparations, half of which contained LDHA and half a placebo. We subjected 100 diabetic patients, from this group 30 IDDM patients were selected for this study with a double masked, randomized, cross–over design vs. fludarene. Were included in the study IDDM patients aged between 20 and 30 years and with refractive error, considered as spherical equivalent, below ± 6D.After a complete eye examination, computerized perimetry was performed with Humphrey Visual Field Analyzer (HFA).For each patient the duration of therapy was three months, compared with three months of fludarene. Patients were also monitored monthly with metabolic examinations. All patients were treated with LDHA once a day for three months and identical period of treatment with placebo, half of patients started with active drug while the other half started with placebo. All examination were repeated at month 3 and 6.
Results: :
Considering the influence of treatment with LDHA on mean sensitivity of computerized perimetry, in treated patients we noted a significative increase of Mean Sensitivity value (p=0.000119), while fludarene group did not showed any change (p=NS). All treated patients showed a statistically significative reduction in SF (p=0.00008); conversely, the fludarene revealed only a slight significative change after treatment (p=0.02).Evaluating Color Vision tests with CCS, this index showed a significantly higher decrease in treated (P=0.02) patients than in placebo (p=NS). All these statistics showed a normally distributed error shift, and a highly significant Student’s "t" test evaluation between treatment vs. placebo group. Moreover all other ocular findings considered, BCVA, IOP and ophthalmoscopic appearance, did not showed significant changes between two groups.
Conclusions: :
In our opinion treatment of LDHA produces improvement in retinal blood circulation, reduction in platelet aggregation, moreover it can favor hemorrhage re–absorption, so several studies have demonstrated the action of LDHA both as a capillary protector and on thrombocyte aggregation, and hence on thrombosis.
Keywords: diabetic retinopathy • diabetes • metabolism