The Zeaxanthin and Visual Function Study (ZVF)

This study has been completed.
Sponsor:
Collaborators:
Kowa Company, Ltd.
IMAGE TECHNOLOGIES INC.
Information provided by (Responsible Party):
Chrysantis, Inc.
ClinicalTrials.gov Identifier:
NCT00564902
First received: November 27, 2007
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Age Related Macular Degeneration
Cognition Disorders
Drug: 3R 3'R Zeaxanthin
Dietary Supplement: Lutein
Dietary Supplement: Lutein and Zeaxanthin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized, Double Blind, Lutein Controlled Study of Zeaxanthin and Visual Function in Atrophic Age Related Macular Degeneration Patients

Resource links provided by NLM:


Further study details as provided by Chrysantis, Inc.:

Primary Outcome Measures:
  • Macular Pigment Optical Density [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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).


Enrollment: 60
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lutein
9 mg of Lutein for 12 months
Dietary Supplement: Lutein
9 mg of Lutein during 12 months
Active Comparator: Zeaxanthin and Lutein
3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
Dietary Supplement: Lutein and Zeaxanthin
8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months
Active Comparator: Zeaxanthin
3R 3'R Zeaxanthin 8 mg per day during 12 months
Drug: 3R 3'R Zeaxanthin
8 mg per day during 12 months
Other Name: EZEyes

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

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564902

Locations
United States, Illinois
North Chicago VA Medical Center
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Chrysantis, Inc.
Kowa Company, Ltd.
IMAGE TECHNOLOGIES INC.
Investigators
Principal Investigator: Stuart Richer, Ph. D. North Chicago VA Medical Center
Study Director: William Stiles, M.D. North Chicago VA Medical Center
  More Information

Publications:

Responsible Party: Chrysantis, Inc.
ClinicalTrials.gov Identifier: NCT00564902     History of Changes
Other Study ID Numbers: CHRY1, IRB 07-046
Study First Received: November 27, 2007
Results First Received: November 11, 2011
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Chrysantis, Inc.:
Macular Pigment Optical Density
Skin Carotenoids
Lipofuscin
Photostress (Glare Recovery)
Visual Field Progression
Contrast Sensitivity
Color Vision
Cognitive Function

Additional relevant MeSH terms:
Cognition Disorders
Macular Degeneration
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014