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Study Data from Duke University Update Knowledge of Pre-Trial Research

March 3, 2014



By a News Reporter-Staff News Editor at Clinical Trials Week -- Fresh data on Clinical Trials and Studies are presented in a new report. According to news reporting originating from Durham, North Carolina, by NewsRx correspondents, research stated, "The authors have recently developed a high-resolution microscope-integrated spectral domain optical coherence tomography (MIOCT) device designed to enable OCT acquisition simultaneous with surgical maneuvers. The purpose of this report is to describe translation of this device from preclinical testing into human intraoperative imaging."

Our news editors obtained a quote from the research from Duke University, "Before human imaging, surgical conditions were fully simulated for extensive preclinical MIOCT evaluation in a custom model eye system. Microscope-integrated spectral domain OCT images were then acquired in normal human volunteers and during vitreoretinal surgery in patients who consented to participate in a prospective institutional review board-approved study. Microscope-integrated spectral domain OCT images were obtained before and at pauses in surgical maneuvers and were compared based on predetermined diagnostic criteria to images obtained with a high-resolution spectral domain research handheld OCT system (HHOCT; Bioptigen, Inc) at the same time point. Cohorts of five consecutive patients were imaged. Successful end points were predefined, including >= 80% correlation in identification of pathology between MIOCT and HHOCT in >= 80% of the patients. Microscope-integrated spectral domain OCT was favorably evaluated by study surgeons and scrub nurses, all of whom responded that they would consider participating in human intraoperative imaging trials. The preclinical evaluation identified significant improvements that were made before MIOCT use during human surgery. The MIOCT transition into clinical human research was smooth. Microscope-integrated spectral domain OCT imaging in normal human volunteers demonstrated high resolution comparable to tabletop scanners. In the operating room, after an initial learning curve, surgeons successfully acquired human macular MIOCT images before and after surgical maneuvers. Microscope-integrated spectral domain OCT imaging confirmed preoperative diagnoses, such as full-thickness macular hole and vitreomacular traction, and demonstrated post-surgical changes in retinal morphology. Two cohorts of five patients were imaged. In the second cohort, the predefined end points were exceeded with >= 80% correlation between microscope-mounted OCT and HHOCT imaging in 100% of the patients. This report describes high-resolution MIOCT imaging using the prototype device in human eyes during vitreoretinal surgery, with successful achievement of predefined end points for imaging."

According to the news editors, the research concluded: "Further refinements and investigations will be directed toward fully integrating MIOCT with vitreoretinal and other ocular surgery to image surgical maneuvers in real time."

For more information on this research see: Preclinical Evaluation And Intraoperative Human Retinal Imaging With A High-resolution Microscope-integrated Spectral Domain Optical Coherence Tomography Device. Retina-The Journal of Retinal and Vitreous Diseases, 2013;33(7):1328-1337. Retina-The Journal of Retinal and Vitreous Diseases can be contacted at: Lippincott Williams & Wilkins, 530 Walnut St, Philadelphia, PA 19106-3621, USA (see also Clinical Trials and Studies).

The news editors report that additional information may be obtained by contacting P. Hahn, Duke University, Dept. of Biomed Engn, Durham, NC 27710, United States. Additional authors for this research include J. Migacz, R. O'Connell, S. Day, A. Lee, P. Lin, R. Vann, A. Kuo, S. Fekrat, P. Mruthyunjaya, E.A. Postel, J.A. Izatt and C.A. Toth.

Keywords for this news article include: Durham, Surgery, United States, North Carolina, Medical Devices, Imaging Technology, Pre-Trial Research, North and Central America, Clinical Trials and Studies, Optical Coherence Tomography,

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Source: Clinical Trials Week


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