- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02423213
DISCOVER Study: Microscope-integrated Intraoperative OCT Study (DISCOVER)
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Justis P Ehlers, M.D.
- Phone Number: 216-636-0183
- Email: ehlersj@ccf.org
Study Contact Backup
- Name: Jamie L Reese, R.N.
- Phone Number: 216-636-0183
- Email: reesej3@ccf.org
Study Locations
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-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cole Eye Institute, Cleveland Clinic
-
Contact:
- Jamie P Ehlers, MD
- Phone Number: 216-636-0183
- Email: ehlersj@ccf.org
-
Contact:
- Jamie L Reese, RN
- Phone Number: 216-636-0183
- Email: reesej3@ccf.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Justis P Ehlers, MD, The Cleveland Clinic
Publications and helpful links
General Publications
- Ehlers JP, Srivastava SK, Feiler D, Noonan AI, Rollins AM, Tao YK. Integrative advances for OCT-guided ophthalmic surgery and intraoperative OCT: microscope integration, surgical instrumentation, and heads-up display surgeon feedback. PLoS One. 2014 Aug 20;9(8):e105224. doi: 10.1371/journal.pone.0105224. eCollection 2014.
- Ehlers JP, Kaiser PK, Srivastava SK. Intraoperative optical coherence tomography using the RESCAN 700: preliminary results from the DISCOVER study. Br J Ophthalmol. 2014 Oct;98(10):1329-32. doi: 10.1136/bjophthalmol-2014-305294. Epub 2014 Apr 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-013
- K23EY022947-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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