New Science!!!

Improvement of Retinal Function in Early Age-Related Macular Degeneration After Lutein and Zeaxanthin
Supplementation: A Randomized, Double-Masked, Placebo-Controlled Trial

Ma L, Dou HL, Huang YM, Lu XR, Xu XR, Qian F, Zou ZY, Pang HL, Dong PC, Xiao X, Wang X, Sun TT, Lin XM

Published July, 2012 American Journal of Ophthalmology – Abstract  and Commentary by Drs Gerson and Pizzimenti below:

Abstract (Click here to visit the publisher’s website for the full study)

Purpose

To examine the effects of lutein and zeaxanthin supplementation on retinal function using multifocal electroretinograms (mfERG) in patients with early age-related macular degeneration (AMD).

Design

Randomized, double-masked, placebo-controlled trial.

Methods

One hundred eight subjects with early AMD were randomly assigned to receive 10 mg/d lutein (n = 27), 20 mg/d lutein (n = 27), 10 mg/d lutein plus 10 mg/d zeaxanthin (n = 27), or placebo (n = 27) for 48 weeks. Thirty-six age-matched controls without AMD were also enrolled to compare baseline data with early AMD patients. MfERG responses and macular pigment optical densities (MPODs) were recorded and analyzed at baseline and at 24 and 48 weeks.

Results

There were significant reductions in N1P1 response densities in ring 1 to ring 3 in early AMD patients compared with the controls (P < .05), whereas neither N1P1 response densities in ring 4 to ring 6 nor P1 peak latencies significantly changed. After 48-week supplementation, the N1P1 response densities showed significant increases in ring 1 for the 20 mg lutein group and for the lutein and zeaxanthin group, and in ring 2 for the 20 mg lutein group. The increases in MPOD related positively to the increases in N1P1 response density in ring 1 and ring 2 for nearly all active treatment groups. N1P1 response densities in ring 3 to ring 6 or P1 peak latencies in all rings did not change significantly in any group.

Conclusion

Early functional abnormalities of the central retina in the early AMD patients could be improved by lutein and zeaxanthin supplementation. These improvements may be potentially attributed to the elevations in MPOD.

Commentary by Dr. Jeffry Gerson and Dr. Joseph Pizzimenti

Supplementation with Macular Pigments Improves Retinal Function

When we recommend nutritional therapy that includes foods and/or supplements high in xanthophylls, we may not only be protecting the retina, but also enhancing its function.  The latest evidence comes from China, where Ma and colleagues examined the effects of lutein and zeaxanthin supplementation on retinal function in patients with early age-related macular degeneration (AMD).

In a randomized, double-masked, placebo-controlled trial, investigators assigned one hundred eight subjects with early AMD to receive one of four interventions: 10 mg/d lutein, 20 mg/d lutein, 10 mg/d lutein plus 10 mg/d dietary zeaxanthin, or a placebo for 48 weeks. Thirty-six age-matched controls without AMD were also enrolled to compare baseline data with early AMD patients.

Multifocal electroretinography (MfERG) responses and macular pigment optical densities (MPODs) were recorded and analyzed at baseline and at 24 and 48 weeks. After 48-weeks, significant improvements in MfERG responses were found in the 20 mg lutein group and in the 10 mg/d lutein plus 10 mg/d dietary zeaxanthin group. Increases in MPOD related positively to the improvements in MfERG responses for nearly all active treatment groups.

This study is notable for its high-level design and relatively high doses of macular pigments, including 10mg of dietary zeaxanthin. Of further importance is the finding of retinal function improvement in early AMD patients as documented by an objective test of MfERG. The authors noted that larger studies are needed to validate their findings and assess the long-term effects of lutein and zeaxanthin on reducing AMD progression.

This study reflecting improvement in retinal function by MfERG correlates nicely with recent studies showing improvement in visual function parameters.  Dr. Stuart Richer has conducted several such studies, most recently the Zeaxanthin and Visual Function Study. (8mg’s/d dietary zeaxanthin for 12 months)  In this study, Dr. Richer demonstrated that dietary zeaxanthin intake can improve contrast sensitivity, acuity, foveal shape discrimination and other important visual parameters.  These improvements could significantly improve patient quality of life.

Supplementation in AMD is no longer just about slowing disease progression.  It has now taken a welcome turn towards optimization of remaining vision and the possibility of measured improvement!

There are several powerful take-aways from these recent studies.  As far as patient education, we can let our patients know there are objective and subjective measurements of improved vision supported by good scientific research.  We can also use these important findings to achieve better acceptance and compliance from our patients.

Jeffry D. Gerson, O.D., F.A.A.O.

Dr. Jeffry Gerson graduated from the Indiana University School of Optometry and completed a residency at VA medical center in Kansas City before becoming faculty at the University of Kansas School of Medicine Ophthalmology department.  Later he became a staff member at Mid America Retina Consultants.  His practice, WestGlen Eyecare provides full scope Optometric care.  Dr. Gerson is a distinguished lecturer and has authored many papers in numerous scientific journals.

Joseph J. Pizzimenti, O.D., F.A.A.O.

Dr. Pizzimenti graduated from the University of IL School of Optometry, owned and operated his own Optometric practice, and is currently Associate Professor at Nova Southeastern University College of Optometry.  Dr. Pizzimenti has conducted important clinical research in the areas of diabetes, AMD, and low vision. Dr. Pizzimenti is a distinguished educator, lecturer, and author of many papers in numerous scientific journals.

ZeaVision® and EyePromise® thank Dr. Gerson and Dr. Pizzimenti for their insights regarding the role of nutrition in ocular health.  To learn more about unique (and only) ocular supplements that contain the dosage of dietary zeaxanthin studied in the aforementioned published clinical trials please contact ZeaVision at 1-866-833-2800 or support@eyepromise.com

EyePromise Science Summary

Download the Science Summary by clicking the PDF icon or read as text below.

AMD & Macular Pigments: (Zeaxanthin and Lutein)

The following 4 studies (Pola, Rotterdam, Blue Mountain, and AREDS Report 22) represent 4 countries, 3 continents, and more than 10,000 subjects…all had the same results: higher levels of Zeaxanthin reduced the risk for AMD!

POLA Study: Zeaxanthin & Lutein (Delcourt et. al. – Investigative Ophthalmology and Visual Science: 2006)

• 899 subjects
• Patients with high plasma levels of Zeaxanthin had a 93% reduction in AMD
• Patients with high plasma levels of Lutein had a 79% reduction in AMD

Rotterdam Study: (Lintje Ho, MD et. al – Archives of Ophthalmology 2011)

• 2,167 subjects
• Participants with genetic AMD risk factors in the highest tertile of dietary zinc, β-carotene, lutein/zeaxanthin, and EPA/DHA intake had a significant hazard ratio reduction for AMD of approximately 40%.

Blue Mountains Eye Study: (Tan, et. al. – American Academy of Ophthalmology: 2008)

• 2,454 subjects
• Higher dietary intake of zeaxanthin and lutein reduced risk of AMD (in 3654 patients) by 65%.
• Confirmed protective influence of zinc.
• Higher beta-carotene associated with increased risk of AMD.

AREDS Report 22: (Emily Chew, MD, et. al. – Archives of Ophthalmology: 2007)

• 4,757 subjects
• Participants reporting highest intake of zeaxanthin & lutein less likely to have advanced AMD (NV & GA) or intermediate drusen.

Serum Carotenoids and Risk of AMD: (Zhou et. al. – Investigative Ophthalmology and Visual Science 2011)

• 263 Chinese subjects
• Serum levels of carotenoids and retinol were significantly lower in cases with exudative AMD than in controls.
• Zeaxanthin (96% Relative Risk Reduction) Lycopene (78% Relative Risk Reduction)
• No significant associations between serum lutein and cases with early or exudative AMD were observed.

Lutein and Zeaxanthin Status and Risk of AMD: (Gale, et. al. Ophthalmology and Visual Science: 2003)

• 380 subjects
• Low levels of Zeaxanthin in plasma = significantly higher risk of AMD
• Did not show similar effect for Lutein
• Possible studies that combine Zeaxanthin & Lutein may obscure protective effect of Zeaxanthin

Three Irish Studies: (Nolan 2006, IOVS: Nolan 2007, O’Connell – Amer. Journal of Clinical Nutrition)

• 828 subjects
• Risk factors for AMD (age, female, smoker, AMD family history, low consumption of zeaxanthin & lutein) = lower macular pigment optical density.
• A major risk factor may be poor uptake of zeaxanthin into the retina from serum.

Macular Pigment In Donor Eyes: (Bone, et. al. – Investigative Ophthalmology and Visual Science 2001)

• 112 cadaver donors, 224 eyes.
• Donor eyes in the highest quartile of lutein and zeaxanthin per unit area had an 82% lower prevalence of AMD compared with those in the lowest quartile.

Zeaxanthin & Visual Performance benefits:

Richer, Stuart, et. al. (Zeaxanthin and Visual Function Trial – Journal of Optometry, November 2011)

• 60 elderly subjects with early to moderate AMD
• Consumed 8mg’s of dietary zeaxanthin per day for 12 months
• Improved high contrast near visual acuity by 8.5 letters or 1.5 lines
• Achieved clearing of central scotomas
• Improved foveal shape discrimination
• Improved night driving skills

Stringham, Hammond, et. al. (Optometry and Visual Science: 2008)

• Retinal increase of zeaxanthin and lutein reduced glare disability thru improved photostress. recovery times. Contrast sensitivity also improved.

Kvansakul, et. al. (Applied Vision Research Centre, City University, London: 2006)

• Zeaxanthin and lutein improve contrast acuity in the mesopic range and may benefit night driving.

Stringham, Hammond, et. al. (Journal of Food Science: 2009)

• Glare induced photostress recovery times can be reduced by 5 seconds by increasing macular pigment via supplementation. This equates to 440 ft. improved reaction time at 60 MPH while driving at night.

Wenzel et. al. (The Association for Research in Vision and Ophthalmology: 2004)

• Macular pigment reduces photophobia caused by lights containing short wavelengths.

Macular Pigment Optical Density Measurement: (MPOD)

Van Der Veen, et al. (Ophthalmology and Physiological Optics 2009)

• MPOD was measured with the QuantifEye device and the method demonstrated good repeatability with (r = 97) and the data are comparable with retinal reflectometry. (r = .78)

MPOD Measurement (Berendschot, et. al. – Eye 2011)

• We found low agreement between test and retest measurements with Macuscope.
• We found high agreement between test and retest measurements of QuantifEye (0.02 ± 0.18) and the fundus reflectance method.