Carotenoids in Age-related Maculopathy Italian Study (CARMIS): two-year results of a randomized study.
OBJECTIVE
The high concentration of carotenoids in the macula, plus evidence linking oxidative stress to age-related macular degeneration (AMD) and carotenoids to antioxidation, generated the hypothesis that higher antioxidant intakes can prevent AMD. The aim of this study was to determine whether nutritional supplementation with a targeted nutritional supplement improves visual acuity and visual function in AMD.


METHODS
In this multicenter, prospective open-label randomized study, 145 patients were randomly assigned to 2 different treatment groups. Interventions were lutein (10 mg), zeaxanthin (1 mg), astaxanthin (4 mg; AZYR SIFI, Catania, Italy), and antioxidants/vitamins supplementation formula or no dietary supplementation for 2 years. Primary outcome was mean changes in visual acuity (VA) at 12 and 24 months. Other measures included contrast sensitivity (CS) and National Eye Institute visual function questionnaire (NEI VFQ-25) scores at 12 and 24 months.


RESULTS
Patients in the treated group showed stabilization of VA with significantly (p=0.003) better VA scores (81.4 ± 7.2) compared to the nontreated group (76.8 ± 8.9) at 24-month follow-up. An improvement in CS (p=0.001) and final mean NEI VFQ-25 composite scores at 12 and 24 months higher in treated group compared to nontreated group were also shown (p<0.001).


CONCLUSIONS
Patients treated with lutein/zeaxanthin and astaxanthin together with other nutrients were more likely to report clinically meaningful stabilization/improvements in VA, CS, and visual function through 24 months compared with nontreated subjects. Further studies are needed with more patients and for longer periods of time.
Department of Ophthalmology, University of Padova, Padova, Italy.
Stefano
S
Piermarocchi
Sandro
S
Saviano
Vincenzo
V
Parisi
Massimiliano
M
Tedeschi
Giacomo
G
Panozzo
Giuseppe
G
Scarpa
Giorgio
G
Boschi
Giuseppe
G
Lo Giudice
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000008:administration & dosage*; D001205:Ascorbic Acid / Q000008:administration & dosage; D002338:Carotenoids / Q000008:administration & dosage*; D015350:Contrast Sensitivity / Q000502:physiology; D003300:Copper / Q000008:administration & dosage; D019587:Dietary Supplements; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D014975:Lutein / Q000008:administration & dosage; D008268:Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000502:physiology; D014810:Vitamin E / Q000008:administration & dosage; D014815:Vitamins / Q000008:administration & dosage*; D024341:Xanthophylls / Q000008:administration & dosage; D065146:Zeaxanthins; D017967:Zinc Compounds / Q000008:administration & dosage
D000975:Antioxidants; D014815:Vitamins; D024341:Xanthophylls; D065146:Zeaxanthins; D017967:Zinc Compounds; D014810:Vitamin E; D002338:Carotenoids; D003300:Copper; C005948:astaxanthine; D001205:Ascorbic Acid; D014975:Lutein