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NCT00478439 Clinical Trial

Investigation of Macular Pigment Augmentation on Dark Adaptation

Aging Clinical Trial

Official title:
Investigation of Macular Pigment Augmentation on Dark Adaptation

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00478439
Other study ID # F070410002
Secondary ID
Status Terminated
Phase Phase 4
First received May 22, 2007
Last updated October 26, 2010
Start date December 2007
Est. completion date October 2010

Study information
Verified date October 2010
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date October 2010
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

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,
• Multivitamin
Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,

Locations
Country Name City State
United States UAB School of Optometry Birmingham Alabama

Sponsors (2)
Lead Sponsor Collaborator
University of Alabama at Birmingham ZeaVision, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dark Adaptation Measured 3 times over 8 months No
Secondary Macular Pigment Density Measured 3 times over 8 months No
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