Overview

This trial is active, not recruiting.

Conditions retinal detachment, epiretinal membrane, macular hole, fuchs endothelial dystrophy
Sponsor The Cleveland Clinic
Collaborator National Eye Institute (NEI)
Start date August 2011
End date August 2014
Trial size 750 participants
Trial identifier NCT02423161, 11-787

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Feasibility of intraoperative OCT
time frame: 3 years

Secondary Outcomes

Measure
Utility of intraoperative OCT
time frame: 3 years
Safety of intraoperative OCT
time frame: 3 years
Time requirements for intraoperative OCT
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The study population includes any patient requiring ophthalmic surgery Exclusion Criteria: - Children under the age of 18 - Cognitive/Mentally impaired or unable to provide consent - Media opacity precluding OCT scanning

Additional Information

Official title Prospective Intraoperative and Perioperative Ophthalmic Imaging With Optical Coherence Tomography: PIONEER Study
Principal investigator Justis P Ehlers, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.