Clinical trial NCT00564902: The Zeaxanthin and Visual Function Study
Official title: Randomized, Double Blind, Lutein Controlled Study of Zeaxanthin and Visual Function in Atrophic Age Related Macular Degeneration Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Chrysantis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kowa Company, Ltd.
name: IMAGE TECHNOLOGIES INC.
First posted: 2007-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: To evaluate whether or not zeaxanthin supplementation raises macular pigment optical density (MPOD). Previous research has shown MPOD to mirror visual benefits for patients with age related atrophic macular degeneration (AMD) having visual symptoms (decreased visual acuity, contrast sensitivity, photostress glare recovery and National Eye Institute Visual Function Questionnaire 25 scores), but lower risk National Eye Institute (NEI) / Age Related Eye Disease Study (AREDS) characteristics.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Macular Pigment Optical Density
timeFrame: 4 months
measure: Macular Pigment Optical Density
timeFrame: 8 months
measure: Macular Pigment Optical Density
timeFrame: 12 months
Secondary outcomes:
measure: SHAPE Discrimination
timeFrame: 12 months
measure: Early Treatment Diabetic Retinopathy Study Distance Visual Acuity
timeFrame: 12 months
measure: Glare Recovery
timeFrame: 12 Months
measure: Contrast Sensitivity Function Photopic Distance
timeFrame: 12 Months
measure: 6.5 Degrees Tritan Threshold
timeFrame: 12 months
measure: 100% Kinetic Field
timeFrame: 12 Months
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: North Chicago VA Medical Center
state: Illinois
Study officials:
affiliation: North Chicago VA Medical Center
name: Stuart Richer, Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: North Chicago VA Medical Center
name: William Stiles, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.