DISCOVER Study: Microscope-integrated Intraoperative OCT Study



Status:Recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/24/2018
Start Date:January 2014
End Date:January 2021
Contact:Justis P Ehlers, M.D.
Email:ehlersj@ccf.org
Phone:216-636-0183

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Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery: DISCOVER Study

Optical coherence tomography (OCT )provides high resolution information regarding the
anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view.
Much of this information is not able to be visualized by a clinician. Utilizing this
information during surgery will allow for the ophthalmic surgeons to better understand how
surgical procedures impact the anatomic structure of the eye.

In this study an OCT device that has been built into the microscope (rather than mounted on
the side or held in the surgeon's hand) and will be utilized to take images at various
milestones during surgery to assess feasibility and potential utility of this technology.
Since it is built into the microscope, there are potential significant advantages over a
separate system including increased efficiency, improved working distance, and the ability to
visualize tissue-instrument interactions.

Optical coherence tomography (OCT) has become a critical component to the evaluation of
ophthalmic disease. Similar to the ultrasound, OCT uses light to reconstruct an image of the
tissue of interest. In effect, OCT functions almost like a light biopsy, allowing clinicians
to visualize subtle changes in the tissue, such as macular edema or subretinal fluid. OCT in
the clinic setting has become the gold standard for monitoring diseases such as macular
degeneration and diabetic retinopathy;and it has become one of the most frequently ordered
diagnostic test in ophthalmology.

Due to the 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-tops 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 the OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during
vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retinal
diseases such as retinal detachment, macular hole and optic pit, that were not previously
known. Our research team has been examining intraoperative OCT in the operating room using
both a handheld and microscope-mounted portable spectral domain OCT probe with excellent
success and an outstanding safety record.

In this study an OCT device that has been built into the microscope (rather than mounted on
the side or held in the surgeon's hand) and will be utilized to take images at various
milestones during surgery to assess feasibility and potential utility of this technology.
Since it is built into the microscope, there are potential significant advantages over a
separate system including increased efficiency, improved working distance, and the ability to
visualize tissue-instrument interactions.

Inclusion Criteria:

- The study population includes any patient requiring ophthalmic surgery

Exclusion Criteria:

- Under the age of 18 years.

- Cognitive/Mentally impaired or unable to provide consent
We found this trial at
1
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Cleveland, Ohio 44195
Phone: 216-636-0183
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