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Sponsors and Collaborators: |
University of Alabama at Birmingham ZeaVision, Inc. |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00478439 |
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 |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Investigation of Macular Pigment Augmentation on Dark Adaptation |
Estimated Enrollment: | 40 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | April 2008 |
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.
Ages Eligible for Study: | 60 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maria Voce | (205) 934-6734 | mvoce@uab.edu |
United States, Alabama | |
UAB School of Optometry | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Gregory R Jackson, PhD | University of Alabama at Birmingham |
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 |
aging age-related macular degeneration macular pigment dark adaptation |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |