Raman Scattering Spectroscopy to Measure Macular Pigment
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 7, 2003 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | May 2003 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00060580 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Raman Scattering Spectroscopy to Measure Macular Pigment |
| Official Title ICMJE | Measurement of Macular Pigment With Resonant Raman Backscattering Spectroscopy |
| Brief Summary | This study will evaluate the ease and reliability of Raman scattering spectroscopy, a new technique to measure the amount of the pigment lutein in the retina, the light-sensitive tissue lining the back of the eye. The highest concentrations of lutein are in the center of the retina, called the macula, which is the area most important for fine, detailed vision. The functions of lutein are not fully known. Besides absorbing blue light, it may help protect against abnormal changes in the retina, such as age-related macular degeneration. Until recently, lutein was measured using long, cumbersome, and difficult tests. This study will evaluate a new instrument that provides faster measurements. It will be tested under different conditions, such as wearing or not wearing glasses or contact lenses, or dilating or not dilating the pupil of the eye. Healthy normal volunteers between 20 and 65 years of age may be eligible for this study, which involves two visits to the NIH Clinical Center, as follows: Visit 1 - Screening
Visit 2 - Repeat Spectroscopy Subjects return 1 week after the screening visit for a repeat Raman scattering spectroscopy to evaluate the precision of the measurements. |
| Detailed Description | The primary objective of this study is to evaluate the degree of variability in retinal measurements of lutein, a carotenoid macular pigment of human retina in normal volunteers, with a new and novel technique of resonant Raman scattering spectroscopy. This technique is generally more objective than psychophysical techniques used for lutein measurements, such as heterochromatic flicker photometry. Raman scattering spectroscopy is non-invasive and the levels of ocular exposure to argon laser light used in this technique are well below the safety limits recommended by the American National Standards Institute. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 1 |
| Study Design ICMJE | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Condition ICMJE | Raman Spectroscopy |
| Intervention ICMJE | Procedure: Raman scattering spectroscopy |
| Study Arm (s) | Not Provided |
| Publications * |
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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 | Completed |
| Enrollment ICMJE | 40 |
| Completion Date | March 2006 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Gender | Both |
| Ages | Not Provided |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00060580 |
| Other Study ID Numbers ICMJE | 030156, 03-EI-0156 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Eye Institute (NEI) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | March 2006 |
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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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