Investigation of Macular Pigment Augmentation on Dark Adaptation

This study is not yet open for participant recruitment.

Verified by University of Alabama at Birmingham, May 2007

First Received: May 22, 2007 No Changes Posted

Sponsors and Collaborators:	University of Alabama at Birmingham ZeaVision, Inc.
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00478439

Purpose

The study will evaluate whether taking a nutritional supplement designed to increase macular pigment in the eye can improve a person's ability to adjust to darkness. Patients will be assigned to take either a placebo or nutritional supplement for 8 months. Vision will be assessed at baseline, 4 months, and 8 months.

Condition	Intervention	Phase
Aging Age-Related Macular Degeneration	Drug: ZeaVision EyePromise Restore	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Investigation of Macular Pigment Augmentation on Dark Adaptation

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Dark Adaptation [ Time Frame: Measured 3 times over 8 months ]

Secondary Outcome Measures:

Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ]

Estimated Enrollment:	40
Study Start Date:	June 2007
Estimated Study Completion Date:	April 2008

Detailed Description:

The study design is a randomized, double-blinded, placebo-controlled intervention study that will evaluate whether macular pigment augmentation improves the speed of dark adaptation. Two groups of participants will be enrolled, old adults with normal vision and early age-related macular degeneration patients. Macular pigment will be augmented using EyePromise RESTORE (ZeaVision, Inc). EyePromise RESTORE is a nutritional supplement that has been found to increase macular pigment levels in some users. Macular pigment level and the speed of dark adaptation (how fast a person adjusts to the dark) will be assessed at baseline, 4-months, and 8-months. Fundus appearance will be assessed at baseline and 8-months follow-up.

Eligibility

Ages Eligible for Study:	60 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

60 to 80 years old
< +- 4.00 diopters spherical equivalent
normal eye health or early age-related macular degeneration

Exclusion Criteria:

neurological conditions that can impair vision
diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478439

Contacts

Contact: Maria Voce

(205) 934-6734

mvoce@uab.edu

Locations

United States, Alabama
UAB School of Optometry
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

ZeaVision, Inc.

Investigators

Principal Investigator:

Gregory R Jackson, PhD

University of Alabama at Birmingham

More Information

No publications provided

Study ID Numbers:	F070410002
Study First Received:	May 22, 2007
Last Updated:	May 22, 2007
ClinicalTrials.gov Identifier:	NCT00478439 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

aging
age-related macular degeneration
macular pigment
dark adaptation

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009