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Investigation of Macular Pigment Augmentation on Dark Adaptation
This study has been terminated.
(Study terminated: Recruitment delay due to equipment malfunction)
Sponsor:
University of Alabama at Birmingham
Collaborator:
ZeaVision, Inc.
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00478439
First received: May 22, 2007
Last updated: October 26, 2010
Last verified: October 2010
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | May 22, 2007 | |||
| Last Updated Date | October 26, 2010 | |||
| Start Date ICMJE | December 2007 | |||
| Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Dark Adaptation [ Time Frame: Measured 3 times over 8 months ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00478439 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ] | |||
| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Investigation of Macular Pigment Augmentation on Dark Adaptation | |||
| Official Title ICMJE | Investigation of Macular Pigment Augmentation on Dark Adaptation | |||
| 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. | |||
| 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 ICMJE | Interventional | |||
| Study Phase | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms | Placebo Comparator: Placebo Comparator
Interventions:
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Enrollment ICMJE | 13 | |||
| Completion Date | October 2010 | |||
| Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 60 Years to 80 Years (Adult, Senior) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00478439 | |||
| Other Study ID Numbers ICMJE | F070410002 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Leo P. Semes, O.D./Principal Investigator, UAB School of Optometry | |||
| Study Sponsor ICMJE | University of Alabama at Birmingham | |||
| Collaborators ICMJE | ZeaVision, Inc. | |||
| Investigators ICMJE |
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| PRS Account | University of Alabama at Birmingham | |||
| Verification Date | October 2010 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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