Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen-An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula.

Pinakin Gunvant Davey,Stephanie Amonoo-Monney,Rebecca Weis,Drake W Lem,Thomas Henderson,David W Evans

doi:10.3390/nu12113271

Pinakin Gunvant Davey, Stephanie Amonoo-Monney + Show 4 more

Open Access

https://doi.org/10.3390/nu12113271

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Abstract

Purpose: To compare the changes in visual and ocular parameters in individuals with retinal drusen who were treated with two commercially available nutritional supplements. Methods: An open-label, single-center, randomized, parallel-treatment with an observational control group design was utilized. The treatment groups included individuals with fine retinal drusen sub-clinical age-related macular degeneration (AMD), while the control group consisted of ocular normal individuals. The treatment groups were randomly assigned to the micronized lipid-based carotenoid supplement, Lumega-Z (LM), or the PreserVision Age-Related Eye Disease Study 2 (AREDS-2) soft gel (PV). Visual performance was evaluated using the techniques of visual acuity, dark adaptation recovery and contrast sensitivity, at baseline, three months, and six months. Additionally, the macular pigment optical density (MPOD) was measured. The control group was not assigned any carotenoid supplement. The right eye and left eye results were analyzed separately. Results: Seventy-nine participants were recruited for this study, of which 68 qualified and 56 participants had useable reliable data. Of the individuals who completed this study, 25 participants belonged to the LM group, 16 belonged to the PV group, and 15 to the control group. The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months (p < 0.001). The LM group displayed a positive linear trend with treatment time in CSF (p < 0.001), with benefits visible after just three months of supplementation. Although there was a trend showing improvement in CSF in the PV group, the change was not significant after a Bonferroni-corrected p-value of p < 0.00625. Visual acuity, dark adaptation recovery and MPOD did not significantly improve in either treatment groups. Conclusion: The LM group demonstrated greater and faster benefits in visual performance as measured by CSF when compared to the PV group. This trial has been registered at clinicaltrials.gov (NCT03946085).

Highlights

Macular carotenoids constitute the macular pigment optical density (MPOD) and are associated with maintaining retinal health and optimal visual performance [2,3,8,15], suggesting the level of MPOD is an important biomarker in health and disease states
This study evaluated the visual benefits and MPOD changes observed with LM supplementation and compared it with the PreserVision (PV) supplementation
The present study showed that LM supplementation in individuals at risk of age-related macular degeneration (AMD) improves

Summary

Introduction

The macular pigment is composed of three carotenoids: lutein, zeaxanthin, and meso-zeaxanthin [1,2].They are responsible for the fovea’s yellow pigmentation and are densely concentrated within the axons of photoreceptors inner plexiform and outer plexiform layers at the center of the macula [1,2,3,4,5].The two carotenoids, lutein and zeaxanthin, can only be acquired through dietary intake and cannot be synthesized within the body [2,6,7]; sources include vegetables, spinach, corn, and egg yolks [2,8]. some foods such as salmon skin, sardine skin, trout skin and trout flesh are known to have meso-zeaxanthin [9], the serum level of meso-zeaxanthin in healthy individuals is approximately0.0003 μmol/L [10]. The two carotenoids, lutein and zeaxanthin, can only be acquired through dietary intake and cannot be synthesized within the body [2,6,7]; sources include vegetables, spinach, corn, and egg yolks [2,8]. Some foods such as salmon skin, sardine skin, trout skin and trout flesh are known to have meso-zeaxanthin [9], the serum level of meso-zeaxanthin in healthy individuals is approximately. Unless individuals are artificially supplemented [10,11], meso-zeaxanthin in human eye is a byproduct of the conversion of lutein in retinal pigment epithelium [2,5,6,12,13,14].

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