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Investigation of Macular Pigment Augmentation on Dark Adaptation

This study has been terminated.
(Study terminated: Recruitment delay due to equipment malfunction)
Sponsor:
Collaborator:
ZeaVision, Inc.
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00478439
First received: May 22, 2007
Last updated: October 26, 2010
Last verified: October 2010
History of Changes
  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
 Dietary Supplement: ZeaVision EyePromise Restore
Dietary Supplement: Multivitamin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Investigation of Macular Pigment Augmentation on Dark Adaptation

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Dark Adaptation [ Time Frame: Measured 3 times over 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: December 2007
Study Completion Date: October 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Comparator Dietary Supplement: ZeaVision EyePromise Restore
Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,
Dietary Supplement: Multivitamin
Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,

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

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: Leo P Semes, O.D. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Leo P. Semes, O.D./Principal Investigator, UAB School of Optometry
ClinicalTrials.gov Identifier: NCT00478439     History of Changes
Other Study ID Numbers: F070410002
Study First Received: May 22, 2007
Last Updated: October 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
aging
age-related macular degeneration
macular pigment
dark adaptation

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013