Dynamic Light Scattering to Study Crystalline Proteins in Young Normal Lenses - Tabular View

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Tracking Information
First Received Date ^†	March 18, 2006
Last Updated Date	March 5, 2008
Start Date ^†	March 2006
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00304967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Dynamic Light Scattering to Study Crystalline Proteins in Young Normal Lenses
Official Title ^†	A Study of Crystalline Proteins in Young Normal Lenses Using the NASA-NEI Dynamic Light Scattering (DLS) Device
Brief 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. 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 Phase
Study Type ^†	Observational
Study Design ^†
Condition ^†	Healthy
Intervention ^†
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	30
Completion Date	March 2007
Primary Completion Date
Eligibility Criteria ^†	INCLUSION CRITERIA 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. EXCLUSION CRITERIA Individuals who cannot cooperate or keep still for the DLS measurements will be excluded.
Gender	Both
Ages	5 Years to 21 Years
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00304967
Responsible Party
Secondary IDs ^††	06-EI-0117
Study Sponsor ^†	National Eye Institute (NEI)
Collaborators ^††
Investigators ^†
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	March 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.