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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

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:   Other, 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     Not yet recruiting
      Birmingham, Alabama, United States, 35294
      Principal Investigator: Gregory R Jackson, PhD            

Sponsors and Collaborators
University of Alabama at Birmingham
ZeaVision, Inc.

Investigators
Principal Investigator:     Gregory R Jackson, PhD     University of Alabama at Birmingham    
  More Information

Study ID Numbers:   F070410002
First Received:   May 22, 2007
Last Updated:   May 22, 2007
ClinicalTrials.gov Identifier:   NCT00478439
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
Retinal degeneration

ClinicalTrials.gov processed this record on August 29, 2008




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