PIONEER: Intraoperative and Perioperative OCT Study

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02423161

Collaborator

National Eye Institute (NEI) (NIH)

750

Enrollment

Location

Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment Epiretinal Membrane Macular Hole Fuchs Endothelial Dystrophy

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

750 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2017

Outcome Measures

Primary Outcome Measures

Feasibility of intraoperative OCT [3 years]
Defined as percentage of cases where OCT was successfully able to be obtained during surgery

Secondary Outcome Measures

Utility of intraoperative OCT [3 years]
Defined as percentage of cases where the OCT altered surgical decision-making based on surgeon-report on questionnaire
Safety of intraoperative OCT [3 years]
Defined as the percentage of subjects that experience adverse events that were related to the intraoperative OCT and/or in excess of what might be expected relative to the surgery performed
Time requirements for intraoperative OCT [3 years]
Defined as the mean number of minutes required to completed intraoperative imaging during a surgical case