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Magnetic Resonance Imaging to Study the Normal Eye

Primary Purpose

Cataract, Lens Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cataract focused on measuring Magnetic Resonance Imaging, Human Eye, Lens, Normal Volunteers, Cataract, Human Lens, Healthy Volunteer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Eye Institute (NEI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 13, 2000
Last Updated
March 3, 2008
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005911
Brief Title
Magnetic Resonance Imaging to Study the Normal Eye
Official Title
Refinement of the Magnetic Resonance Imaging Technique for the Study of the Normal Eye, Particularly the Lens and Cataract
Study Type
Observational

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Disease
Keywords
Magnetic Resonance Imaging, Human Eye, Lens, Normal Volunteers, Cataract, Human Lens, Healthy Volunteer

7. Study Design

Enrollment
20 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
National Eye Institute (NEI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6787220
Citation
Kinoshita JH, Kador P, Catiles M. Aldose reductase in diabetic cataracts. JAMA. 1981 Jul 17;246(3):257-61. No abstract available.
Results Reference
background
PubMed Identifier
1001376
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. doi: 10.1016/0014-4835(76)90157-3. No abstract available.
Results Reference
background
PubMed Identifier
6799419
Citation
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.
Results Reference
background

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Magnetic Resonance Imaging to Study the Normal Eye

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