Raman SpectroscopyPhase 1NCT00060580
Raman Scattering Spectroscopy to Measure Macular Pigment
A Phase 1 study testing Raman scattering spectroscopy in people with Raman Spectroscopy, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Raman Spectroscopy
- What is being tested?
- Raman scattering spectroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Mar 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men and women between 18 and 75 years of age.
- Corrected visual acuity of 20/30 or better.
- Ability to understand and sign an informed consent form prior to enrollment.
Who cannot join
- Ocular disease, including significant explained or unexplained visual field loss.
- Ocular media opacities.
- History of epilepsy or light-triggered convulsions.
- A maximal pupillary dilation of less than 7 mm.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
Official title: Measurement of Macular Pigment With Resonant Raman Backscattering Spectroscopy
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:
Read more
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 object from the background and to see everyday objects. The subject looks at and identifies a variety of objects of different shapes and sizes.
- Color vision to determine the ability to identify different shades of color. The subject arranges a line of colorful discs, similar to checkers, in order of similar shades.
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.
Read the 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.
- Conditions
- Raman Spectroscopy
- Being tested
- Raman scattering spectroscopy
- Keywords
- Retinal Measurements, Lutein in Vivo, Raman Spectroscopy, Retinal Measurements of Lutein in Vivo in the Human Eye, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman scattering spectroscopyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2003 (estimated)
- Study startMay 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Raman SpectroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060580
- Sponsor's protocol ID
- 030156
- Other IDs
- 03-EI-0156
- Status last verified
- Mar 2006
- First submitted
- 7 May 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bone RA, Landrum JT, Tarsis SL. Preliminary identification of the human macular pigment. Vision Res. 1985;25(11):1531-5. doi: 10.1016/0042-6989(85)90123-3.
PubMed 3832576Landrum JT, Bone RA, Joa H, Kilburn MD, Moore LL, Sprague KE. A one year study of the macular pigment: the effect of 140 days of a lutein supplement. Exp Eye Res. 1997 Jul;65(1):57-62. doi: 10.1006/exer.1997.0309.
PubMed 9237865Seddon JM, Ajani UA, Sperduto RD, Hiller R, Blair N, Burton TC, Farber MD, Gragoudas ES, Haller J, Miller DT, et al. Dietary carotenoids, vitamins A, C, and E, and advanced age-related macular degeneration. Eye Disease Case-Control Study Group. JAMA. 1994 Nov 9;272(18):1413-20.
PubMed 7933422
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Macular Pigment With Resonant Raman Backscattering Spectroscopy
- ClinicalTrials.gov ID
- NCT00060580
- Acronym / sponsor ID
- 030156
- Conditions
- Raman Spectroscopy
- Keywords
- Retinal Measurements, Lutein in Vivo, Raman Spectroscopy, Retinal Measurements of Lutein in Vivo in the Human Eye, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- May 2003
- Study completion
- Mar 2006
- First posted
- 8 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 object from the background and to see everyday objects. The subject looks at and identifies a variety of objects of different shapes and sizes.
- Color vision to determine the ability to identify different shades of color. The subject arranges a line of colorful discs, similar to checkers, in order of similar shades.
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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women between 18 and 75 years of age.
- Corrected visual acuity of 20/30 or better.
- Ability to understand and sign an informed consent form prior to enrollment.
Key exclusion criteria (4 listed)
- Ocular disease, including significant explained or unexplained visual field loss.
- Ocular media opacities.
- History of epilepsy or light-triggered convulsions.
- A maximal pupillary dilation of less than 7 mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raman scattering spectroscopy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3832576Bone RA, Landrum JT, Tarsis SL. Preliminary identification of the human macular pigment. Vision Res. 1985;25(11):1531-5. doi: 10.1016/0042-6989(85)90123-3.
- Background: PubMed 9237865Landrum JT, Bone RA, Joa H, Kilburn MD, Moore LL, Sprague KE. A one year study of the macular pigment: the effect of 140 days of a lutein supplement. Exp Eye Res. 1997 Jul;65(1):57-62. doi: 10.1006/exer.1997.0309.
- Background: PubMed 7933422Seddon JM, Ajani UA, Sperduto RD, Hiller R, Blair N, Burton TC, Farber MD, Gragoudas ES, Haller J, Miller DT, et al. Dietary carotenoids, vitamins A, C, and E, and advanced age-related macular degeneration. Eye Disease Case-Control Study Group. JAMA. 1994 Nov 9;272(18):1413-20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Raman scattering spectroscopy in people with Raman Spectroscopy, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060580, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.