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S. P. Richer, W. Stiles, K. Graham, C. Thomas, L. Clouser, J. Nyland, P. Touzeau, J. Bekritsky, D. Richer, D. Park; The Zeaxanthin and Atrophic AMD Visual Function Study (ZVF)- Investigator Initiated FDA IND #78,973. Invest. Ophthalmol. Vis. Sci. 2008;49(13):4973.
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© ARVO (1962-2015); The Authors (2016-present)
In LAST I, II (Optom 2004 75; 4:216-30 & 2007 78; 5: 213-9) we demonstrated that lutein induced macular pigment optical density (MPOD) elevation mirrored visual benefits for patients with age related macular degeneration (AMD) by improving visual symptoms (i.e. better VA, CSF, photostress glare recovery). We now describe the design / baseline data of a randomized, double blind, lutein controlled study of the predominant foveal carotenoid zeaxanthin (Z) on MPOD, visual function, retinal blood flow & neuro-cognitive status in atrophic AMD.
A 1 year, 4 visit, prospective, randomized, double blind, both "intention-to-treat" & "per-protocol using only observed data", lutein controlled study of patients with mild and moderate AMD, but not advanced disease. Sample: 60 AMD patients (approx 120 eyes) randomly assigned to one of 2 dietary supplement treatment carotenoid pigment arms (8mg Z; n=25 & 8mg Z / 9mg L; n=25), or to a traditional 9 mg lutein supplement intervention control group (n=10). General Data includes, NEI VFQ25, Harvard Dietary FFI GP88, BMI / % body fat & biophotonic skin carotenoid scan. Non- dilated near refraction data includes SKILL & Colenbrander low contrast VA, 10° kinetic 3 wavelength - 5 contrast Amsler Grid, Foveal QuantifEYE 1° HFF MPOD & an APA administered neuro-cognitive assessment. Non dilated distance refraction data includes EDTRS VA, CSF, 6.5° large letter ChromaTest Tritan/Protan thresholds & Kowa AS14B Photostress Glare Recovery. Dilated Ophthalmic tests include an Image Technologies Autofluorescence 14° 3D MPOD distribution (Sharifzadeh M, Bernstein PS, Gellermann W, J Opt Soc Am 2006 23(10):2373-87), 50° retinal & RPE lipofuscin images, Heidelberg HRF (10° deg x 2.5°) foveal-centered laser doppler nasal/temporal parafoveal sensory retinal blood flow & LOCS III lens classification.
Baseline demographic, visual function, ocular and neuro- cognitive assessment profiles post randomization are provided.
Although, the power and time frame of this study are probably insufficient to assess clinical AMD disease progression, our comprehensive data set should provide unique insights about AMD visual function and response to supplemental nutritional carotenoids.
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