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PIONEER: Intraoperative and Perioperative OCT Study (PIONEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02423161
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Justis Ehlers, The Cleveland Clinic

Brief Summary:
OCT provides high-resolution information regarding the anatomic structure of the tissues of the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be recognized by a clinician. Utilizing this information during surgery will allow for ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.

Condition or disease
Retinal Detachment Epiretinal Membrane Macular Hole Fuchs Endothelial Dystrophy

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Feasibility of intraoperative OCT [ Time Frame: 3 years ]
    Defined as percentage of cases where OCT was successfully able to be obtained during surgery


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population includes any patient requiring ophthalmic surgery
Criteria

Inclusion Criteria:

  • The study population includes any patient requiring ophthalmic surgery

Exclusion Criteria:

  • Children under the age of 18
  • Cognitive/Mentally impaired or unable to provide consent
  • Media opacity precluding OCT scanning

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Eye Institute (NEI)
Investigators
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Principal Investigator: Justis P Ehlers, MD Cole Eye Institute, Cleveland Clinic, OH 44195
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Justis Ehlers, Assistant Professor of Ophthalmology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02423161    
Other Study ID Numbers: 11-787
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Keywords provided by Justis Ehlers, The Cleveland Clinic:
OCT
image-guided surgery
vitreoretinal surgery
corneal surgery
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Perforations
Epiretinal Membrane
Fuchs' Endothelial Dystrophy
Retinal Diseases
Eye Diseases
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn