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The Zeaxanthin and Visual Function Study (ZVF)

Primary Purpose

Age Related Macular Degeneration, Cognition Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3R 3'R Zeaxanthin
Lutein
Lutein and Zeaxanthin
Sponsored by
Chrysantis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Age Related Macular Degeneration focused on measuring Macular Pigment Optical Density, Skin Carotenoids, Lipofuscin, Photostress (Glare Recovery), Visual Field Progression, Contrast Sensitivity, Color Vision, Cognitive Function

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • North Chicago VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Lutein

Zeaxanthin and Lutein

Zeaxanthin

Arm Description

9 mg of Lutein for 12 months

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

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

Outcomes

Primary Outcome Measures

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).
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).
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.

Secondary Outcome Measures

SHAPE Discrimination
We determined the target deformation detection thresholds, or amplitude of the minimum detectable distortion of a 1 degree foveal circular target. The peak spatial frequency of RF (radial frequency) patterns was 5 cyc/deg; the radial modulation frequency was 8 cyc/360°; mean radii were 0.5°, 1°, 2.0°, or 2.5°; and stimulus contrast was 80%. The highest % modulation score possible is 0.13 while the easiest (lowest score) was 10% modulation.
Early Treatment Diabetic Retinopathy Study Distance Visual Acuity
Black and 10% contrast near reading visual acuity was assessed with a Colenbrander Mixed Contrast Reading Card with LogMAR letters (#4031, Precision Vision, LaSalle, Illinois). We determined single letter acuity on an ordinal VAS (Visual Acuity Scale). The largest letters were 0.05 LogMAR with a VAS = 35 while the most difficult smallest letters were LogMar 1.25 or VAS 105. The test card was held at 40 cm with best monocular refraction, and both low and high contrast letter acuity were assessed.
Glare Recovery
Photostress glare recovery test involves exposing an individual eye to intense light, or retinal bleach, for a set duration of time and measuring the time taken for visual acuity to recover to a predetermined level. Glare photo-stress recovery (in seconds) following 30 seconds of continuous retinal bleach, was assessed using 2 line supra-threshold low contrast randomly presented Landolt Cs using the KOWA AS14B Night Vision Tester (KOWA Optimed, Tokyo, Japan).
Contrast Sensitivity Function Photopic Distance
Distance photopic contrast sensitivity function (CSF) at 5 spatial frequencies (1.5, 3, 6, 12 & 20 cc/deg) was determined with the Functional Vision Analyzer® (Stereo Optical Co, Inc, Chicago, IL). Contrast sensitivity readings are shown as a curve. Visual acuity is plotted along the horizontal axis and contrast sensitivity along the vertical axis. Among the normally sighted people, both visual acuity and contrast sensitivity have a wide range of variation.Low population CSF is 0-200 units; normal population CSF is 200-300 units and suprathreshold CSF is 300+ units.
6.5 Degrees Tritan Threshold
The ChromaTest© is a computerized psychophysical test of protan and tritan color thresholds against age-corrected data. The computer finds the endpoint of the test by a Modified Binary Search method; if response is correct, on the next presentation the color difference between letter and background is halved. If response is incorrect, the color -contrast is doubled. Incorrect responses prolong the test, but do not influence the final threshold. This method of determining thresholds leads to finite steps which reach a plateau at the color contrast sensitivity threshold.
100% Kinetic Field
Scotomas within the central 20 degree central macula visual field sensitivity was assessed at 5 contrast levels (20, 40, 60, 80, and full contrast). A yellow wavelength stimulus avoided confounding by the lens. Subjects outlined the boundaries of their scotoma(s) on an area-integrating and recording touch flat- screen RGB monitor displaying a central fixation point and movable horizontal/vertical raster lines. The computer calculated summed area of the scotoma(s) with arbitrary scaling from 6000 (dense scotoma) to 0 relative units (absence of scotoma).

Full Information

First Posted
November 27, 2007
Last Updated
March 28, 2012
Sponsor
Chrysantis, Inc.
Collaborators
Kowa Company, Ltd., IMAGE TECHNOLOGIES INC.
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1. Study Identification

Unique Protocol Identification Number
NCT00564902
Brief Title
The Zeaxanthin and Visual Function Study
Acronym
ZVF
Official Title
Randomized, Double Blind, Lutein Controlled Study of Zeaxanthin and Visual Function in Atrophic Age Related Macular Degeneration Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chrysantis, Inc.
Collaborators
Kowa Company, Ltd., IMAGE TECHNOLOGIES INC.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lutein
Arm Type
Placebo Comparator
Arm Description
9 mg of Lutein for 12 months
Arm Title
Zeaxanthin and Lutein
Arm Type
Active Comparator
Arm Description
3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
Arm Title
Zeaxanthin
Arm Type
Active Comparator
Arm Description
3R 3'R Zeaxanthin 8 mg per day during 12 months
Intervention Type
Drug
Intervention Name(s)
3R 3'R Zeaxanthin
Other Intervention Name(s)
EZEyes
Intervention Description
8 mg per day during 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein
Intervention Description
9 mg of Lutein during 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein and Zeaxanthin
Intervention Description
8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months
Primary Outcome Measure Information:
Title
Macular Pigment Optical Density
Description
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).
Time Frame
4 months
Title
Macular Pigment Optical Density
Description
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).
Time Frame
8 months
Title
Macular Pigment Optical Density
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
SHAPE Discrimination
Description
We determined the target deformation detection thresholds, or amplitude of the minimum detectable distortion of a 1 degree foveal circular target. The peak spatial frequency of RF (radial frequency) patterns was 5 cyc/deg; the radial modulation frequency was 8 cyc/360°; mean radii were 0.5°, 1°, 2.0°, or 2.5°; and stimulus contrast was 80%. The highest % modulation score possible is 0.13 while the easiest (lowest score) was 10% modulation.
Time Frame
12 months
Title
Early Treatment Diabetic Retinopathy Study Distance Visual Acuity
Description
Black and 10% contrast near reading visual acuity was assessed with a Colenbrander Mixed Contrast Reading Card with LogMAR letters (#4031, Precision Vision, LaSalle, Illinois). We determined single letter acuity on an ordinal VAS (Visual Acuity Scale). The largest letters were 0.05 LogMAR with a VAS = 35 while the most difficult smallest letters were LogMar 1.25 or VAS 105. The test card was held at 40 cm with best monocular refraction, and both low and high contrast letter acuity were assessed.
Time Frame
12 months
Title
Glare Recovery
Description
Photostress glare recovery test involves exposing an individual eye to intense light, or retinal bleach, for a set duration of time and measuring the time taken for visual acuity to recover to a predetermined level. Glare photo-stress recovery (in seconds) following 30 seconds of continuous retinal bleach, was assessed using 2 line supra-threshold low contrast randomly presented Landolt Cs using the KOWA AS14B Night Vision Tester (KOWA Optimed, Tokyo, Japan).
Time Frame
12 Months
Title
Contrast Sensitivity Function Photopic Distance
Description
Distance photopic contrast sensitivity function (CSF) at 5 spatial frequencies (1.5, 3, 6, 12 & 20 cc/deg) was determined with the Functional Vision Analyzer® (Stereo Optical Co, Inc, Chicago, IL). Contrast sensitivity readings are shown as a curve. Visual acuity is plotted along the horizontal axis and contrast sensitivity along the vertical axis. Among the normally sighted people, both visual acuity and contrast sensitivity have a wide range of variation.Low population CSF is 0-200 units; normal population CSF is 200-300 units and suprathreshold CSF is 300+ units.
Time Frame
12 Months
Title
6.5 Degrees Tritan Threshold
Description
The ChromaTest© is a computerized psychophysical test of protan and tritan color thresholds against age-corrected data. The computer finds the endpoint of the test by a Modified Binary Search method; if response is correct, on the next presentation the color difference between letter and background is halved. If response is incorrect, the color -contrast is doubled. Incorrect responses prolong the test, but do not influence the final threshold. This method of determining thresholds leads to finite steps which reach a plateau at the color contrast sensitivity threshold.
Time Frame
12 months
Title
100% Kinetic Field
Description
Scotomas within the central 20 degree central macula visual field sensitivity was assessed at 5 contrast levels (20, 40, 60, 80, and full contrast). A yellow wavelength stimulus avoided confounding by the lens. Subjects outlined the boundaries of their scotoma(s) on an area-integrating and recording touch flat- screen RGB monitor displaying a central fixation point and movable horizontal/vertical raster lines. The computer calculated summed area of the scotoma(s) with arbitrary scaling from 6000 (dense scotoma) to 0 relative units (absence of scotoma).
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Richer, Ph. D.
Organizational Affiliation
North Chicago VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Stiles, M.D.
Organizational Affiliation
North Chicago VA Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
North Chicago VA Medical Center
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16723441
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.
Results Reference
background
PubMed Identifier
17084803
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.
Results Reference
background
PubMed Identifier
15117055
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.
Results Reference
background
PubMed Identifier
17478338
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.
Results Reference
background
PubMed Identifier
15916761
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.
Results Reference
background
PubMed Identifier
15326146
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.
Results Reference
background
PubMed Identifier
17389729
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.
Results Reference
background
PubMed Identifier
12407166
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.
Results Reference
background

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The Zeaxanthin and Visual Function Study

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