Abstract
Purpose: :
To investigate the effects of short–term supplementation with carotenoids and antioxidants on ETDRS visual acuity scores and on visual function (39–item NEI–VFQ) in patients with age–related macular degeneration (ARMD).
Methods: :
One hundred–fiftythree subjects with ARMD (AREDS category 3 and 4) and visual acuity equal or greater than 20/32 (0.3 LogMAR) in at least one eye have been enrolled and randomly divided into two groups: a treatment group (T–ARMD, n=102 patients) who received oral daily supplementation with Vitamin C (180 mg), Vitamin E (30 mg), Zinc (22.5 mg), Copper (1 mg), Lutein (10 mg), Zeaxanthin (1 mg) and Astaxanthin (4 mg) (AZYR SIFI®, Sifi Italy); a control group (C–ARMD, n=44 patients) received no treatment (7 drop–out). The eye with better visual acuity was considered. Visual acuity was measured with ETDRS visual acuity charts at baseline (T0), 6 months (T6) and 12 months (T12) after entering the study. The Italian–validated version of the 39–item NEI–VFQ was administered to all patients at T0 and T12. Mean scores of ETDRS, overall index and specific NEI–VFQ subscales were compared between AREDS 3 (A3) and AREDS 4 (A4) and within the same subgroup between T–ARM and C–ARM. Out of the whole sample, 45 subjects (30 treated and 15 controls) have so far completed the 12–month follow–up and have been considered for the present analysis.
Results: :
At baseline patients showed homogeneous parameters as to ETDRS scores and NEI–VFQ according to category distribution. After 1–year supplementation T–ARMD A3 patients showed stabilization of visual acuity and significantly better ETDRS scores (87.15±6.08) compared to the C–ARMD A3 group (79.58±6.93) (P=0.02). In the A3 group, VFQ–39 overall scores significantly increased in T–ARM (P=0.001) while near vision and mental health significantly worsened in C–ARM (P=0.034; P=0.014). No significant differences have been observed within the A4 group.
Conclusions: :
Free radicals play a major role in the pathogenesis of ARMD. Epidemiological studies pointed out that patients with higher intake of carotenoids showed reduced risk of ARMD progression, despite few trials have been performed in order to study the efficacy of carotenoid supplementation. Our data show that carotenoid and antioxidant supplementation stabilizes the visual acuity and positively influences the vision–related quality of life. However, since the sample is limited, the present data are to be confirmed in a larger population.
Keywords: age-related macular degeneration • quality of life • antioxidants