Effect of Carotenoids Supplementation on Visual Function in Chinese Subjects

Launched by ZHONGSHAN OPHTHALMIC CENTER, SUN YAT-SEN UNIVERSITY · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether taking a daily supplement containing certain natural pigments, called carotenoids, can improve vision, specifically contrast sensitivity, in Chinese adults aged 35 and older. These carotenoids, lutein, meso-zeaxanthin, and zeaxanthin, are thought to be beneficial for eye health and may help protect against age-related vision problems. Participants will be divided into two groups: one group will receive the carotenoid supplement, while the other group will receive a placebo (a dummy pill that looks the same but has no active ingredients). The study will last for 12 months, with check-ins at 3, 6, and 12 months to see how participants' vision changes over time.

To be eligible for this trial, participants must be Chinese, at least 35 years old, and have good vision (meaning they can see well without significant issues). They should not have any serious eye diseases or have taken similar supplements in the past year. Throughout the study, participants can expect regular visits for eye examinations and assessments of their visual function. It's important to note that this trial is not yet recruiting participants, so there will be more information available soon for those interested in taking part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Chinese subjects
• • Age 35 years or above
• • Monocular BCVA of 6/6 or better
• • No more than +/- 5 diopters spherical equivalence of refraction
• • No previous consumption of supplements containing macular carotenoids (L, Z and/or MZ) within the last 12 months
• • Without severe retinal diseases (eg. retinal detachment, glaucoma, macular hole, idiopathic epiretinal membrane, retinitis pigmentosa, and age-related macular degeneration (assessed by experienced ophthalmologists during ocular examination)
• Exclusion Criteria:
• • Unable to provide informed consent
• • With diagnosed diabetes
• • With severe systemic disease which affects physical mobility and successful follow-up
• • Contrast sensitivity at a spatial density of 6 cpd ≤ 1.5 % at baseline in the eye with better visual acuity
• • Subjects who plan to receive cataract surgery within the next year
• • Subjects who are unable to cooperate with the examinations during follow-ups, such as those who suffer from other serious systemic diseases or mental abnormalities
• • History of intraocular surgery (eg. cataract surgery, vitrectomy and retinal laser photocoagulation)