PIONEER: Intraoperative and Perioperative OCT Study



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/26/2018
Start Date:August 2011
End Date:August 2017

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Prospective Intraoperative and Perioperative Ophthalmic Imaging With Optical Coherence Tomography: PIONEER Study

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.

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.

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
We found this trial at
1
site
Cleveland, Ohio 44195
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Cleveland, OH
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