Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478439
Status:
TERMINATED
Last Update Posted:
2010-10-27
First Post:
2007-05-22
Brief Title:
Investigation of Macular Pigment Augmentation on Dark Adaptation
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Investigation of Macular Pigment Augmentation on Dark Adaptation
Status:
TERMINATED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated Recruitment delay due to equipment malfunction
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate whether taking a nutritional supplement designed to increase macular pigment in the eye can improve a persons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None