Protocol Number: 03-EI-0275

Title:

Pilot Study on the Use of the NASA-NEI Dynamic Light Scattering (DLS) Device in Detecting lens Changes in the other Eye of Patients with Pre-Senile Cataracts

Number:

03-EI-0275

Summary:

This study will use a new dynamic light scattering device (DLS), developed jointly by NASA and the NEI, to study pre-senile cataracts (cataracts that develop in patients 55 years old or less). Cataract is a clouding of the lens that interferes with the passage of light to the retinal, impairing visual acuity. DLS uses a low intensity laser light (similar to that used in supermarket checkouts) to measures 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.

Patients 55 years of age or younger with cataract may be eligible for this study. Candidates will be screened with the following tests and procedures:

- Medical history and physical examination.

- Eye examination, including measurement of visual acuity (vision chart) and eye pressure; examination of pupils and eye movements; dilation of the pupils for examination of the lens and the back of the eye (retina).

- Cataract photography using a camera with a bright flash to assess the status of the cataract and evaluate future changes.

- Blood drawing if necessary for clinical care.

Participants will have a standard eye examination, as described above, plus DLS testing. For this procedure, the patient sits in front of the DLS device, with the chin placed on a chin rest. He or she fixes on a yellow-green target in the center of the camera lens. When the eye is properly aligned, the measurement is taken and the reddish light on the side of the camera lens turns on for 5 seconds. Measurements are taken on three layers of the lens. The procedure takes less than 30 minutes.

Participants will be followed at the NIH clinic once a month for up to 1 year to follow progression of the cataract. The visits will include a repeat of some of the exams listed above.

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 55 years of age or younger with cataracts (pre-senile cataracts) will be admitted to this study.

Ten subjects who have cataracts and who are 55 years of age or younger, of either sex, will be recruited. DLS data will be obtained on the eye with no or little cataract every month for a year or until cataract surgery is required. AREDS grading will be utilized but will not be used as a protocol end point.

EXCLUSION CRITERIA

Patients who have uveitis, glaucoma and 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.

Special Instructions: Currently Not Provided

Keywords:

Cataract

Pre-Senile

Dynamic Light Scattering (DLS)

Light Scattering

Lens

Recruitment Keywords:

Cataracts

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

Ansari RR, Datiles MB 3rd. Use of dynamic light scattering and Scheimpflug imaging for the early detection of cataracts.

Diabetes Technol Ther. 1999 Summer;1(2):159-68.

PMID: 11475288

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