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

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).

Keywords: AREDS-2; Lumega-Z; MPOD; PreserVision; age-related macular degeneration; carotenoids; contrast sensitivity; lutein; macular degeneration; macular pigment; medical food; meso-zeaxanthin; zeaxanthin.

Conflict of interest statement

The authors of this manuscript have the following competing interests: Pinakin Davey serves as a consultant for Guardion Health Sciences. He has performed research on the CSV-1000E contrast sensitivity system which is owned by VectorVision. VectorVision is now a wholly owned subsidiary of Guardion Health Sciences. Other associations unrelated to this study: Pinakin Davey serves as a consultant to Zeavision LLC, which manufactures various nutritional supplements—none of which were used in this study. Davey is on the speaker’s bureau of Bausch Health for a Glaucoma medication Vyzulta and has received honorarium. Bausch Health are the manufacturers of the PreserVision AREDS-2 supplement. David Evans is an employee of Guardion Health Sciences and owns shares in the company. Evans is the inventor of the CSV-1000 contrast sensitivity system and founder of VectorVision. Guardion Health Sciences acquired VectorVision in September 2017. D.W.L, T.H., R.W. and S.A.-M. have no conflicts of interest.

Figures

Figure 1
Figure 1
Flow chart showing study outline: subject enrollment, randomization, follow up and sample size analyzed. Lumega-Z (LM), PreserVision (PV).

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