PIONEER: Intraoperative and Perioperative OCT Study (PIONEER)
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|ClinicalTrials.gov Identifier: NCT02423161|
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : January 24, 2018
|Condition or disease|
|Retinal Detachment Epiretinal Membrane Macular Hole Fuchs Endothelial Dystrophy|
Over the last decade, optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT has become to function as a light biopsy, allowing clinicians to visualize subtle pathologic changes in the tissue, such as macular edema or subretinal fluid. The use of OCT in the clinic setting has become the standard for monitoring diseases such as macular degeneration and diabetic retinopathy. It has quickly become the most frequent ordered diagnostic test in ophthalmology.
Due to restraints in the size and structure of the imaging equipment, the use of OCT in the operating room has been limited. More recently, modifications to OCT table-top models as well as the development of hand-held OCT probes have allowed for the translation of OCT technology into the operating room. The high resolution anatomic information that is gained from OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retina in diseases such as retinal detachment, macular hole, and optic pit, that were not previously known. Using OCT during lamellar corneal transplant procedures, anterior segment surgeons have been able to image proper placement of the graft that was previously unattainable with a standard surgical microscopic view.
Using information gained from OCT, surgeons may be able to improve surgical decision making and improve clinical outcomes. For this study, subjects undergoing ophthalmic surgery, including vitreoretinal surgery and anterior segment surgery, would have OCT imaging performed in the perioperative period, intraoperative period, or both to document architectural changes in the ocular tissues. This information would be prospectively collected and reviewed for associations with anatomic and functional outcomes.
A microscope-mounted OCT system will be used to assess feasibility and utility of imaging during ophthalmic surgical milestones.
|Study Type :||Observational|
|Actual Enrollment :||750 participants|
|Official Title:||Prospective Intraoperative and Perioperative Ophthalmic Imaging With Optical Coherence Tomography: PIONEER Study|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2017|
- Feasibility of intraoperative OCT [ Time Frame: 3 years ]Defined as percentage of cases where OCT was successfully able to be obtained during surgery
- Utility of intraoperative OCT [ Time Frame: 3 years ]Defined as percentage of cases where the OCT altered surgical decision-making based on surgeon-report on questionnaire
- Safety of intraoperative OCT [ Time Frame: 3 years ]Defined as the percentage of subjects that experience adverse events that were related to the intraoperative OCT and/or in excess of what might be expected relative to the surgery performed
- Time requirements for intraoperative OCT [ Time Frame: 3 years ]Defined as the mean number of minutes required to completed intraoperative imaging during a surgical case
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423161
|United States, Ohio|
|Cole Eye Institute, Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Justis P Ehlers, MD||Cole Eye Institute, Cleveland Clinic, OH 44195|