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Investigation of Macular Pigment Augmentation on Dark Adaptation

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ClinicalTrials.gov Identifier: NCT00478439
Recruitment Status : Terminated (Study terminated: Recruitment delay due to equipment malfunction)
First Posted : May 24, 2007
Last Update Posted : October 27, 2010
Sponsor:
Collaborator:
ZeaVision, Inc.
Information provided by:
University of Alabama at Birmingham

Brief Summary:
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 or disease Intervention/treatment Phase
Aging Age-Related Macular Degeneration Dietary Supplement: ZeaVision EyePromise Restore Dietary Supplement: Multivitamin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Investigation of Macular Pigment Augmentation on Dark Adaptation
Study Start Date : December 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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,



Primary Outcome Measures :
  1. Dark Adaptation [ Time Frame: Measured 3 times over 8 months ]

Secondary Outcome Measures :
  1. Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: October 2010

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