NIH Clinical Research Studies

Protocol Number: 04-EI-0166

Active Accrual, Protocols Recruiting New Patients

Title:
A Cross Sectional Clinical Study of Human Lens Aging and Cataract Formation, in Vivo, Using Dynamic Light Scattering (DLS)
Number:
04-EI-0166
Summary:
This study will use dynamic light scattering (DLS) technology to study normal lens aging and early cataract formation. Cataract is a clouding of the lens that interferes with the passage of light to the retina, impairing visual acuity. DLS uses a low intensity laser light (similar to that used in supermarket checkouts) to measure lens cloudiness. It detects changes in the human lens at the earliest molecular stages of cataract development, when anti-cataract treatment would be most effective in reversing, delaying or preventing cataract formation.

Healthy normal volunteers and patients with age-related cataract between 18 and 80 years of age may be eligible for this study. Participants undergo the following tests and procedures:

Medical history

Eye examination, including the following:

- Measurement of visual acuity (vision chart)

- Measurement of eye pressure

- Dilation of the pupils for slit lamp (microscope) examination and grading of lens opacity

- Ultrasound examination of the eye to determine distances between cornea, lens (including lens thickness), and retina

- Examination of the retina at the back of the eye

- Dynamic light scattering of the lens (see below)

- Lens photography using a camera with a bright flash

For the DLS procedure, the patient sits in front of the DLS device with his or her chin placed on a chin rest and fixes on a yellow target in the center of the camera lens. When the eye is properly aligned, DLS measurements are taken on the lens.

Sponsoring Institute:
National Eye Institute (NEI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Patients aged 18-80 years will be admitted to this study. There will be no racial or gender bias in the recruitment.

227 patients with AREDS Clinical Grades 2 or less for nuclear cataract, will be enrolled in the study. 40 patients with AREDS nuclear cataract grade 3 and 4 will also be enrolled.

For those patients enrolled from the AREDS population, only one eye will be evaluated for this protocol. The eye to be examined will be defined as follows: If the patient has only one eligible eye, that eye will be examined. If the patient's birth month is an even number, the right eye will be examined; if the patient's birth month is odd, the left eye will be examined.

EXCLUSION CRITERIA:

Subjects who have tear film disorders, corneal opacities or disorders, uveitis, glaucoma or who have difficulty fixating, will be excluded.

Subjects who are thought to be at risk for an adverse reaction to pupil dilation, or have a history of allergic reaction to one of the dilating agents that will be used, will be excluded.

Special Instructions: Currently Not Provided
Keywords:
Cataract
Blindness
Clinical
Human Aging
Dynamic Light Scattering (DLS)
Aging-Related Lens Changes
Early Cataract
Lens
AREDS Grading
In Vivo
Recruitment Keywords:
Cataract
Healthy Volunteer
Conditions:
Cataract
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Benedek GB, Chylack LT Jr, Libondi T, Magnante P, Pennett M.

Quantitative detection of the molecular changes associated with early cataractogenesis in the living human lens using quasielastic light scattering. Curr Eye Res. 1987 Dec;6(12):1421-32. PMID: 3427992

Datiles M, Podgor M, Edwards P. Reproducibility of the Early Cataract Detector (Kowa ECD 2000). Ophthalmic Surg. 1988 Sep;19(9):664-6. PMID: 3186178

Bursell SE, Baker RS, Weiss JN, Haughton JF, Rand LI. Clinical photon correlation spectroscopy evaluation of human diabetic lenses. Exp Eye Res. 1989 Aug;49(2):241-58. PMID: 2767171

Active Accrual, Protocols Recruiting New Patients

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