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| Sponsored by: |
University of Pittsburgh |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00343473 |
Purpose
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.
| Condition | Phase |
|
Fuch's Dystrophy Corneal Disorders Subjects Who Have Had Refractive Surgery |
Phase I |
| Genetics Home Reference related topics: | Eye Diseases |
| MedlinePlus related topics: | CT Scans Eye Diseases Surgery |
| Study Type: | Observational |
| Study Design: | Other, Other |
| Official Title: | Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
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
Eligibility
| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects will range form 18 years to 90 years. Gender can be male or female. Will include 100 normals and 100 diseased patients that include diabetic retinopathy, macular degeneration, and glaucoma.
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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Contacts and Locations| Contact: Kristy A Truman, COA | 412-647-3971 | trumank@upmc.edu |
| Contact: Gail Engleka, COA | 412-383-9884 | Englekag@upmc.edu |
| United States, Pennsylvania | |||||
| University of Pittsburgh UPMC Eye Center | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Sub-Investigator: Joel S Schuman, MD | |||||
| Principal Investigator: Gadi Wollstein, MD | |||||
| University of Pittsburgh |
| Study Chair: | Joel S Schuman, MD | University of Pittsburgh |
| Study Director: | Robert J Noecker, MD | University of Pittsburgh |
| Study Director: | Gadi Wollstein, MD | University of Pittsburgh |
| Study Director: | Hiroshi Ishikawa, MD | University of Pittsburgh |
More Information
| Responsible Party: | UPMC Eye center ( Gail Engleka COA ) |
| Study ID Numbers: | 0309020, Ro1 EY 11289-15 |
| First Received: | June 19, 2006 |
| Last Updated: | February 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00343473 |
| Health Authority: | United States: Institutional Review Board |
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