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DISCOVER Study: Microscope-integrated Intraoperative OCT Study (DISCOVER)

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ClinicalTrials.gov Identifier: NCT02423213
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Justis Ehlers, The Cleveland Clinic

Study Description
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Brief Summary:

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.


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

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery: DISCOVER Study
Study Start Date : January 2014
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2024

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To assess feasibility of microscope-integrated intraoperative OCT [ Time Frame: 3 years ]
    Feasibility will be assessed as the percentage of cases where OCT images were successfully obtained with a microscope-integrated system


Secondary Outcome Measures :
  1. To assess utility of microscope-integrated intraoperative OCT on surgical decision-making [ Time Frame: 3 years ]
    Utility will be assessed through a surgeon-feedback questionnaire, including the percentage of cases where the OCT information changed the surgical approach to the case according to the surgeon.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population includes any patient requiring ophthalmic surgery who meets the inclusion criteria for feasibility of OCT imaging.
Criteria

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
Contacts and Locations
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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): NCT02423213


Contacts
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Contact: Justis P Ehlers, M.D. 216-636-0183 ehlersj@ccf.org
Contact: Jamie L Reese, R.N. 216-636-0183 reesej3@ccf.org

Locations
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United States, Ohio
Cole Eye Institute, Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jamie P Ehlers, MD    216-636-0183    ehlersj@ccf.org   
Contact: Jamie L Reese, RN    216-636-0183    reesej3@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
National Eye Institute (NEI)
Investigators
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Principal Investigator: Justis P Ehlers, MD The Cleveland Clinic
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Justis Ehlers, Assistant Professor of Ophthalmology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02423213    
Other Study ID Numbers: 14-013
K23EY022947-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Justis Ehlers, The Cleveland Clinic:
OCT
image-guided surgery
ophthalmic surgery
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Perforations
Retinal Diseases
Epiretinal Membrane
Fuchs' Endothelial Dystrophy
 Eye Diseases
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn