View Clinical Trial (Medical Research Study)
Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Fuch's Dystrophy - Corneal Disorders - Prior Surgery |
| Purpose: |
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The purpose of this research is to evaluate the optical coherence tomography (OCT), to image
diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety
of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal
damage (eye diseases in the back of the eye) due to diabetes.
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| Study Summary: |
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The purpose of this research is to evaluate the optical coherence tomography (OCT), to image
diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety
of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal
damage (eye diseases in the back of the eye) due to diabetes. OCT may also be useful for
assessing contact lens and surgical procedures, such as LASIK (type of ophthalmic surgical
procedure). The OCT is Food and Drug Administration (FDA) approved. The ultra high OCT is
a non-significant risk device (it does not present a possible serious risk to your health,
your safety, or your welfare) that has not been approved by the FDA. This study will also
be conducted at the Massachusetts Institute of Technology and Tufts-New England Medical
Center New England Eye Center in Massachusetts
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| Criteria: |
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Inclusion Criteria: Female Subjects who are pregnant or breastfeeding will be included (no
risks to fetus).
Normals: Normal appearing cornea, no history of corneal trauma, surgery or disease, no
historical or current contact lens wear. Thirty subjects from 6 different age groups (>
18 yrs; 20-30 yrs; 30-40 yrs; 40-50 yrs; 50-60 yrs; > 60 yrs) will be recruited to
determine the normal variations in anterior eye structure.
LASIK patients: to participate as a LASIK patient, the subject is previously normal but
may have worn contact lenses, and is scheduled to undergo LASIK.
Contact lens wearers: to participate as a contact lens wearer the patient otherwise
fulfills all criteria specified for normalcy, with the exception of contact lens wear.
Fuchs' dystrophy patients: Fuchs' Dystrophy is characterized by guttata and clinically
significant corneal edema, with a corneal thickness of >700 microns, and/or reduced visual
acuity in the morning which improves over the course of the day.
Diabetic patients: for diabetic patients are specified in the posterior segment imaging
section.
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Exclusion Criteria:Subjects will be excluded from the study if their media are opaque, or
if they are unwilling or unable to participate in the study.
If participants choose they may also participate in other imaging research protocols. No
risk is associated if entering multiple imaging protocols, while being a participant in
this research study.
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| NCT ID: |
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NCT00343473 |
| Primary Contact: |
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Study Chair
Joel S Schuman, MD
University of Pittsburgh
Kristy A Truman, COA
Phone: 412-383-8778
Email: trumank@upmc.edu
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| Backup Contact: |
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Email: salaymd@upmc.edu
Melessa Salay
Phone: 412-383-9884
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| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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