The Zeaxanthin and Visual Function Study

NCT00564902 | Completed Results DMC

• 2 other identifiers: CHRY1IRB 07-046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate Atrophic Age Related Macular Degeneration.

Conditions

Age Related Macular Degeneration; Cognition Disorders

Keywords

Macular Pigment Optical Density; Skin Carotenoids; Lipofuscin; Photostress (Glare Recovery); Visual Field Progression; Contrast Sensitivity; Color Vision; Cognitive Function

Outcome Measures

Primary Outcomes (3)

• Macular Pigment Optical Density

  Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).

  4 months

• Macular Pigment Optical Density

  Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).

  8 months

• Macular Pigment Optical Density

  Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering light emitting diodes and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated.

  12 months

Secondary Outcomes (6)

• SHAPE Discrimination

  12 months

• Early Treatment Diabetic Retinopathy Study Distance Visual Acuity

  12 months

• Glare Recovery

  12 Months

• Contrast Sensitivity Function Photopic Distance

  12 Months

• 6.5 Degrees Tritan Threshold

  12 months

Study Arms (3)

Lutein

PLACEBO COMPARATOR

9 mg of Lutein for 12 months

Dietary Supplement: Lutein

Zeaxanthin and Lutein

ACTIVE COMPARATOR

3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months

Dietary Supplement: Lutein and Zeaxanthin

Zeaxanthin

ACTIVE COMPARATOR

3R 3'R Zeaxanthin 8 mg per day during 12 months

Drug: 3R 3'R Zeaxanthin

Interventions

3R 3'R Zeaxanthin DRUG

8 mg per day during 12 months

Also known as: EZEyes

Zeaxanthin

Lutein DIETARY_SUPPLEMENT

9 mg of Lutein during 12 months

Lutein

Lutein and Zeaxanthin DIETARY_SUPPLEMENT

8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months

Zeaxanthin and Lutein

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of atrophic AMD (ICD9 362.51) by stereo bio-ophthalmoscopy and at least one vision degrading visual-psychophysical abnormality associated with AMD in one or both eyes.
• clear non-lenticular ocular media (cornea, aqueous and vitreous)
• free of advanced glaucoma and diabetes or any other ocular or systemic disease that could affect central or parafoveal macula visual function

You may not qualify if:

• high risk retinal characteristics for advanced AMD or advanced AMD for which existing medical / surgical options are available
• presence of ophthalmologically significant active exudative, AMD pathology by fluorescein angiography but also a single large drusen, \>15, multiple intermediate drusen, parafoveal geographic atrophy or loss of vision in one eye due to advanced AMD
• recent (within 6 months) cataract or retinal surgery
• taking photosensitizing drugs such as phenothiazines and chloroquine
• having taken lutein or zeaxanthin supplements within the past six months.

Sponsors & Collaborators

• Chrysantis, Inc.: lead
• Kowa Company, Ltd.: collaborator
• IMAGE TECHNOLOGIES INC.: collaborator

Study Sites (1)

North Chicago VA Medical Center

North Chicago, Illinois, 60064, United States

Location

Related Publications (9)

• Delcourt C, Carriere I, Delage M, Barberger-Gateau P, Schalch W; POLA Study Group. Plasma lutein and zeaxanthin and other carotenoids as modifiable risk factors for age-related maculopathy and cataract: the POLA Study. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2329-35. doi: 10.1167/iovs.05-1235.

  PMID: 16723441 BACKGROUND

• Schalch W, Cohn W, Barker FM, Kopcke W, Mellerio J, Bird AC, Robson AG, Fitzke FF, van Kuijk FJ. Xanthophyll accumulation in the human retina during supplementation with lutein or zeaxanthin - the LUXEA (LUtein Xanthophyll Eye Accumulation) study. Arch Biochem Biophys. 2007 Feb 15;458(2):128-35. doi: 10.1016/j.abb.2006.09.032. Epub 2006 Nov 7.

  PMID: 17084803 BACKGROUND

• Richer S, Stiles W, Statkute L, Pulido J, Frankowski J, Rudy D, Pei K, Tsipursky M, Nyland J. Double-masked, placebo-controlled, randomized trial of lutein and antioxidant supplementation in the intervention of atrophic age-related macular degeneration: the Veterans LAST study (Lutein Antioxidant Supplementation Trial). Optometry. 2004 Apr;75(4):216-30. doi: 10.1016/s1529-1839(04)70049-4.

  PMID: 15117055 BACKGROUND

• Richer S, Devenport J, Lang JC. LAST II: Differential temporal responses of macular pigment optical density in patients with atrophic age-related macular degeneration to dietary supplementation with xanthophylls. Optometry. 2007 May;78(5):213-9. doi: 10.1016/j.optm.2006.10.019.

  PMID: 17478338 BACKGROUND

• Leung IY, Sandstrom MM, Zucker CL, Neuringer M, Max Snodderly D. Nutritional manipulation of primate retinas. IV. Effects of n--3 fatty acids, lutein, and zeaxanthin on S-cones and rods in the foveal region. Exp Eye Res. 2005 Nov;81(5):513-29. doi: 10.1016/j.exer.2005.03.009.

  PMID: 15916761 BACKGROUND

• Neuringer M, Sandstrom MM, Johnson EJ, Snodderly DM. Nutritional manipulation of primate retinas, I: effects of lutein or zeaxanthin supplements on serum and macular pigment in xanthophyll-free rhesus monkeys. Invest Ophthalmol Vis Sci. 2004 Sep;45(9):3234-43. doi: 10.1167/iovs.02-1243.

  PMID: 15326146 BACKGROUND

• Akbaraly NT, Faure H, Gourlet V, Favier A, Berr C. Plasma carotenoid levels and cognitive performance in an elderly population: results of the EVA Study. J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):308-16. doi: 10.1093/gerona/62.3.308.

  PMID: 17389729 BACKGROUND

• Thomson LR, Toyoda Y, Langner A, Delori FC, Garnett KM, Craft N, Nichols CR, Cheng KM, Dorey CK. Elevated retinal zeaxanthin and prevention of light-induced photoreceptor cell death in quail. Invest Ophthalmol Vis Sci. 2002 Nov;43(11):3538-49.

  PMID: 12407166 BACKGROUND

• Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

  PMID: 37702300 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Cognition Disorders

Interventions

Zeaxanthins; Lutein

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Stuart P. Richer
• Organization: James A. Lovell Federal Health Care Center

Stuart.Richer1@va.gov

224-610-5440

Study Officials

• Stuart Richer, Ph. D.

  North Chicago VA Medical Center

  PRINCIPAL INVESTIGATOR

• William Stiles, M.D.

  North Chicago VA Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 29, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 29, 2012
• Results First Posted: March 29, 2012

Record last verified: 2012-03

Locations

US (1)