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NCT00060580 · ClinicalTrials.gov registry record · Phase 1
Raman Scattering Spectroscopy to Measure Macular Pigment
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00060580 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 40 participants.
The verdict
NCT00060580, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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 * Medical history and physical examination, including measurement of vital signs (blood pressure, pulse, temperature, and breathing rate), and examination of the head and neck, heart and lungs, and arms and legs. * Eye examination, including eye chart test, eye pressure measurement, examination of pupils and eye movements, and examination of the retina (back part of the eye) using a strong light and magnifying lens after dilation of the pupils. * Raman scattering spectroscopy to measure lutein. For this test, the subject looks with one eye at a brief, bright flash of bluish light (similar to a flashbulb light) from a laser. This is repeated several times. Subjects who wear glasses or contact lenses for distance vision will be tested without them and then again with a lens in front of the eye. Subjects who do not wear glasses or contact lenses will be tested before and after dilation of the pupil. * Contrast sensitivity to assess ability to identify an obje
Interventions
- PROCEDURE Raman scattering spectroscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2003-05 |
| Est. Completion | 2006-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00060580
The ClinicalTrials.gov registry entry for NCT00060580 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Raman scattering spectroscopy is the first listed.
NCT00060580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00060580 about?
NCT00060580 is a clinical study titled "Raman Scattering Spectroscopy to Measure Macular Pigment". 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 macul...
What is the current status of trial NCT00060580?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2003-05. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00060580?
The interventions under investigation include: Raman scattering spectroscopy (PROCEDURE).
Who is sponsoring clinical trial NCT00060580?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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