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| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | June 19, 2006 | ||||||||||||||||
| Last Updated Date | October 13, 2008 | ||||||||||||||||
| Start Date ICMJE | October 2005 | ||||||||||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||
| Change History | Complete list of historical versions of study NCT00343473 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye | ||||||||||||||||
| Official Title ICMJE | Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye | ||||||||||||||||
| Brief Summary | 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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| Detailed Description | 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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| Study Phase | Phase I | ||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Other, Other | ||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||
| Publications * | Christopoulos V, Kagemann L, Wollstein G, Ishikawa H, Gabriele ML, Wojtkowski M, Srinivasan V, Fujimoto JG, Duker JS, Dhaliwal DK, Schuman JS. In vivo corneal high-speed, ultra high-resolution optical coherence tomography. Arch Ophthalmol. 2007 Aug;125(8):1027-35. | ||||||||||||||||
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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 | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||||||||||
| Estimated Completion Date | October 2010 | ||||||||||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | 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. - 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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| Gender | Both | ||||||||||||||||
| Ages | 18 Years to 90 Years | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00343473 | ||||||||||||||||
| Responsible Party | Gail Engleka COA, UPMC Eye center | ||||||||||||||||
| Study ID Numbers ICMJE | 0309020, Ro1 EY 11289-15 | ||||||||||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||||||||||||||
| Verification Date | October 2008 | ||||||||||||||||
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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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