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| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 13, 2000 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | June 2000 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005911 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Magnetic Resonance Imaging to Study the Normal Eye |
| Official Title ICMJE | Refinement of the Magnetic Resonance Imaging Technique for the Study of the Normal Eye, Particularly the Lens and Cataract |
| Brief 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. |
| Detailed 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 20 |
| Completion Date | August 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00005911 |
| Responsible Party | |
| Study ID Numbers ICMJE | 000151, 00-EI-0151 |
| Study Sponsor ICMJE | National Eye Institute (NEI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | August 2002 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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