DISCOVER Study: Microscope-integrated Intraoperative OCT Study

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02423213
Collaborator
National Eye Institute (NEI) (NIH)
3,000
1
120
25

Study Details

Study Description

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.

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

Study Type:
Observational
Anticipated Enrollment :
3000 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 :
Jan 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. To assess feasibility of microscope-integrated intraoperative OCT [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Cole Eye Institute, Cleveland Clinic Cleveland Ohio United States 44195

Sponsors and Collaborators

  • The Cleveland Clinic
  • National Eye Institute (NEI)

Investigators

  • Principal Investigator: Justis P Ehlers, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Justis Ehlers, Assistant Professor of Ophthalmology, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02423213
Other Study ID Numbers:
  • 14-013
  • K23EY022947-01A1
First Posted:
Apr 22, 2015
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Justis Ehlers, Assistant Professor of Ophthalmology, The Cleveland Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022