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| Sponsor: | University of Alabama at Birmingham |
|---|---|
| Collaborator: |
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 |
Dietary Supplement: ZeaVision EyePromise Restore Dietary Supplement: Multivitamin |
Phase IV |
| 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 |
| 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,
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| UAB School of Optometry | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Leo P Semes, O.D. | University of Alabama at Birmingham |
More Information
| 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 |
|
aging age-related macular degeneration macular pigment dark adaptation |
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
