HealthyNCT00304967
Dynamic Light Scattering to Study Crystalline Proteins in Young Normal Lenses
An observational study of Healthy, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will use a method called dynamic light scattering (DLS) to study the lens of the eye in young normal subjects. The DLS device uses a very dim laser light to study the lens of the eye. It detects proteins in the lens, identifying early changes that may make the device useful in future cataract studies. Read more about this study
- Who is it for?
- Ages 5 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2006to 31 Mar 2007
- Phase
- Observational
- 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 5 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The study will enroll 30 normal control subjects, aged 5-21 years. Eligible participants must have normal clear lenses as determined by the eye examination.
Who cannot join
- Individuals who cannot cooperate or keep still for the DLS measurements will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Study of Crystalline Proteins in Young Normal Lenses Using the NASA-NEI Dynamic Light Scattering (DLS) Device
This study will use a method called dynamic light scattering (DLS) to study the lens of the eye in young normal subjects. The DLS device uses a very dim laser light to study the lens of the eye. It detects proteins in the lens, identifying early changes that may make the device useful in future cataract studies. This study will use DLS to examine the characteristics of proteins in healthy young lenses that can be used for comparison with lenses in older people and people with cataracts.
Normal volunteers aged 5 to 21 years may be eligible for this study. Participants undergo the following procedures:
Read more
Medical history
Eye examination with dilation to include:
- Measurement of visual acuity
- Examination of pupils and eye movements
- Examination of the front of the eye (cornea, lens) with a slit lamp bio-microscope
- Examination of retina with an ophthalmoscope (instrument with a strong light and magnifying lens)
- Dynamic light scattering
Read the detailed description
The NASA-NEI Dynamic Light Scattering (DLS) device detects early molecular lens changes before clinical means are able to detect any lens changes in animal and limited human studies. This ability will make it very useful in future clinical studies of cataract etiology as well as treatment. A recently concluded clinical cross sectional study of lenses (in vivo) using the DLS device showed good reproducibility and good correlation with clinical cataract grading. It also detected remarkable changes in the lens crystalline proteins with aging and with cataract formation. We therefore propose to study the characteristics of the crystalline proteins in pristine young normal lenses with DLS for comparison with aging and cataractous lens findings. We will examine 30 young normal subjects, perform undilated eye examinations, and obtain DLS measurements of their lenses. We will then use these DLS measurements for comparison with the previously obtained aging and cataract DLS measurements, to obtain normative data for future lens and cataract clinical studies.
- Conditions
- Healthy
- Keywords
- Cataract, Normal Lenses, Lens Crystallines, Dynamic or Quasielastic Light Scattering (DLS), Eye Examinations, Healthy Volunteer, HV, Eye Examination
- Medical subject headings
- Cataract
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study start15 Mar 2006
- Study completion31 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304967
- Sponsor's protocol ID
- 060117
- Other IDs
- 06-EI-0117
- Status last verified
- 31 Mar 2007
- First submitted
- 18 Mar 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Van Laethem M, Babusiaux B, Neetens A, Clauwaert J. Photon correlation spectroscopy of light scattered by eye lenses in in vivo conditions. Biophys J. 1991 Feb;59(2):433-44. doi: 10.1016/S0006-3495(91)82237-8.
PubMed 2009358
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Crystalline Proteins in Young Normal Lenses Using the NASA-NEI Dynamic Light Scattering (DLS) Device
- ClinicalTrials.gov ID
- NCT00304967
- Acronym / sponsor ID
- 060117
- Conditions
- Healthy
- Keywords
- Cataract, Normal Lenses, Lens Crystallines, Dynamic or Quasielastic Light Scattering (DLS), Eye Examinations, Healthy Volunteer, HV, Eye Examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 15 Mar 2006
- Study completion
- 31 Mar 2007
- First posted
- 20 Mar 2006 (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 use a method called dynamic light scattering (DLS) to study the lens of the eye in young normal subjects. The DLS device uses a very dim laser light to study the lens of the eye. It detects proteins in the lens, identifying early changes that may make the device useful in future cataract studies. This study will use DLS to examine the characteristics of proteins in healthy young lenses that can be used for comparison with lenses in older people and people with cataracts.
Normal volunteers aged 5 to 21 years may be eligible for this study. Participants undergo the following procedures:
Medical history
Eye examination with dilation to include:
- Measurement of visual acuity
- Examination of pupils and eye movements
- Examination of the front of the eye (cornea, lens) with a slit lamp bio-microscope
- Examination of retina with an ophthalmoscope (instrument with a strong light and magnifying lens)
- Dynamic light scattering
Detailed description
The NASA-NEI Dynamic Light Scattering (DLS) device detects early molecular lens changes before clinical means are able to detect any lens changes in animal and limited human studies. This ability will make it very useful in future clinical studies of cataract etiology as well as treatment. A recently concluded clinical cross sectional study of lenses (in vivo) using the DLS device showed good reproducibility and good correlation with clinical cataract grading. It also detected remarkable changes in the lens crystalline proteins with aging and with cataract formation. We therefore propose to study the characteristics of the crystalline proteins in pristine young normal lenses with DLS for comparison with aging and cataractous lens findings. We will examine 30 young normal subjects, perform undilated eye examinations, and obtain DLS measurements of their lenses. We will then use these DLS measurements for comparison with the previously obtained aging and cataract DLS measurements, to obtain normative data for future lens and cataract clinical studies.
Study design
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The study will enroll 30 normal control subjects, aged 5-21 years. Eligible participants must have normal clear lenses as determined by the eye examination.
Key exclusion criteria (1 listed)
- Individuals who cannot cooperate or keep still for the DLS measurements will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 2 Jul 2017.
- Background: PubMed 2009358Van Laethem M, Babusiaux B, Neetens A, Clauwaert J. Photon correlation spectroscopy of light scattered by eye lenses in in vivo conditions. Biophys J. 1991 Feb;59(2):433-44. doi: 10.1016/S0006-3495(91)82237-8.
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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?
An observational study of Healthy, 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 1 inclusion and 1 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 2 Jul 2017. 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.
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 NCT00304967, which also lists 1 linked publication.
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 2 Jul 2017.