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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005911
Other study ID # 000151
Secondary ID 00-EI-0151
Status Completed
Phase N/A
First received June 13, 2000
Last updated March 3, 2008
Start date June 2000
Est. completion date August 2002

Study information

Verified date August 2002
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This study will assess the value of improved magnetic resonance imaging (MRI) techniques to study the lens of the human eye. Knowledge of how cataracts develop and progress has been hampered by the lack of human tissue available for study; MRI may provide an effective means for learning more about this eye disease.

Normal volunteers between 18 and 70 years of age may be eligible for this study. Participants will undergo a medical history and complete eye examination, including vision assessment, eye pressure measurement, lens and retina examinations, and photography of the eye.

MRI scans will be scheduled for a second visit. For this procedure, the volunteer's pupils are dilated and he or she then lies on a stretcher that is moved into a cylinder containing a magnetic field. A device similar to a welder's helmet is placed on the head. Attached to the device are an imaging probe and a small blinking light. The probe receives radio signals from the eye that a computer converts into images. During imaging, the participant gazes at the blinking light; this helps keep the eyes from blinking and wandering. Scan times vary from 2 to 10 minutes; the total time for the study is less than an hour.


Description:

Studies of human diabetic cataract and age related cataract formation have been hampered by unavailability of human tissues especially in the early stages of the disease. Eye bank tissues are first used for cornea transplants so that by the time they become available for basic research studies, the lens is no longer suitable for biochemical nor histological studies. Cataracts usually only become available after extraction which is at the end stage of their development. However, appropriate surgical lens specimens are no longer available because cataracts are generally extracted by the destructive phakoemulsification technique. Therefore, noninvasive techniques are required in order to study the lens in vivo.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Must be between 18 and 70 years of age of either sex.

Must not have uveitis, glaucoma, or be at risk for an adverse reaction to dilation or have a history of allergic reaction to one of lthe dilating agents to be used.

Must not have any metallic prosthesis, cardiac pacemakers, neural pacemakers, surgical clips in the brain or on blood vessels, surgically implanted metal plates, screws or pins, cochlear implants or metal objects in the body especially in the eye.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Eye Institute (NEI) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Datiles M, Fukui H, Kuwabara T, Kinoshita JH. Galactose cataract prevention with sorbinil, an aldose reductase inhibitor: a light microscopic study. Invest Ophthalmol Vis Sci. 1982 Feb;22(2):174-9. — View Citation

Kinoshita JH, Kador P, Catiles M. Aldose reductase in diabetic cataracts. JAMA. 1981 Jul 17;246(3):257-61. — View Citation

Reddy VN, Schwass D, Chakrapani B, Lim CP. Biochemical changes associated with the development and reversal of galactose cataracts. Exp Eye Res. 1976 Nov;23(5):483-93. — View Citation

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