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| Sponsor: | National Eye Institute (NEI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00069199 |
Purpose
This study, conducted at the NIH Clinical Center and the University of Wisconsin University, will compare measurements obtained using older and newer models of a machine called an optical coherence tomography (OCT) scanner. This instrument uses a beam of light to measure the thickness of the retina, the light-sensitive inner lining of the back of the eye. OCT measurements will be done in multicenter clinical trials of new treatments for disorders that cause vision loss, such as macular edema. Because some centers in these studies will use the older OCT model and some the newer one, it is necessary to determine whether the two models give comparable results.
People 18 years of age and older in the following categories may be eligible for this study:
Participants will have the following tests and procedures:
Patients who are being treated for macular edema will repeat the same tests at their 3-month visits.
| Condition |
|---|
|
Retinal Disease Healthy |
| Study Type: | Observational |
| Official Title: | Optical Coherence Tomography Comparative Study |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | August 2005 |
The use of the Optical Coherence Tomography (OCT) has increased markedly over the recent years for clinical research. It is a promising new method for imaging the retina, measuring its thickness, and displaying some features of this structure. It is useful in assessing several eye diseases, including macular edema from various causes and abnormalities of the vitreoretinal interface. There is a broad clinical consensus that OCT is superior to stereoscopic color fundus photography, fluorescein angiography, and clinical biomicroscopic examination in measuring retinal thickness and is capable of documenting fairly small changes in thickness. OCT is becoming an important part of clinical trials of new treatments for macular edema. A number of models of the OCT device are commercially available, models 1, 2, and 3. A number of models of OCT have been used in clinical centers involved in such clinical research. Comparisons of these models 2 and 3 as well as the reproducibility of these measurements have not been conducted. The main research questions to be answered in this protocol are the following, in patients with normal retina, diabetic macular edema, macular edema from other causes, or other vitreoretinal abnormalities:
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
1. Any condition such as corneal opacifiation that precludes adequate slit lamp examination and photography of the fundus.
Contacts and Locations
More Information
| Study ID Numbers: | 030294, 03-EI-0294 |
| Study First Received: | September 17, 2003 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00069199 History of Changes |
| Health Authority: | United States: Federal Government |
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Reproducibility Macular Edema OCT2 |
OCT3 Macular Edema Retina |
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Eye Diseases Retinal Diseases |