Vision Disorders Clinical Trial
Official title:
Effect of Carotenoids Supplementation on Visual Function in Chinese Subjects Free of Retinal Disease: A Randomized Clinical Trial
The macula is a pigmented area at the center of the retina, and responsible for the central, high-resolution color vision. Age-related macular degeneration (AMD) is a disease of the macula and is the leading cause of irreversible vision impairment and blindness worldwide. The yellow pigment at the macula is referred to as macular pigment. There is now strong evidence showing that macular pigment (MP), which is composed of the dietary carotenoids lutein (L), meso-zeaxanthin (MZ), and zeaxanthin (Z) is protective against AMD and vision loss. MP is a powerful antioxidant and also filters short-wavelength (blue) light at the macula. The AREDS2 study concluded that supplementation of L and Z is beneficial for patients with non-advanced age-related macular degeneration (AMD). The CREST and other studies had reported that dietary supplementation of these carotenoids could enhance contrast sensitivity among the Caucasian population, whereas little information is known about the effect of dietary supplementation of carotenoids on contrast sensitivity among Chinese. Thus in this study, we aim to investigate whether supplementation of a formulation containing 10 mg L, 10 mg MZ, and 2mg Z on contrast sensitivity in Chinese subjects free of retinal disease. This study is a single-center, double-blinded, placebo-controlled, randomized clinical trial conducted at Zhongshan Ophthalmic Center (ZOC), Sun Yat-sen University, Guangzhou, China. Participants in the intervention group received oral supplementation of 10 mg L, 10 mg MZ, and 2mg Z in a formula base oil suspension as one soft gel capsule in the morning per day. Participants in the control group receive one soft gel capsule of placebo oil per day. The intervention and placebo supplements are identical in external appearance, and the two treatments are therefore indistinguishable from each other. The duration of the study intervention is 12 months, and study visits are conducted at baseline, 3 months, 6 months, and 12 months. The primary outcome measure is the change in contrast sensitivity (CS) at 6 cycles per degree (cpd) over the study course: Y=CS4-CS1, where CS1 is CS at 6 cpd at baseline, CS4 is the CS at 6cpd at the 12-month follow-up. The secondary outcomes of this study include CS at other cpds and at other study visits, best-corrected visual acuity, subjective visual function, and skin carotenoid levels at each study visit.
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