PIONEER: Intraoperative and Perioperative OCT Study (PIONEER)

January 23, 2018 updated by: Justis Ehlers, The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cole Eye Institute, Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population includes any patient requiring ophthalmic surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of intraoperative OCT
Time Frame: 3 years
Defined as percentage of cases where OCT was successfully able to be obtained during surgery
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of intraoperative OCT
Time Frame: 3 years
Defined as percentage of cases where the OCT altered surgical decision-making based on surgeon-report on questionnaire
3 years
Safety of intraoperative OCT
Time Frame: 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
3 years
Time requirements for intraoperative OCT
Time Frame: 3 years
Defined as the mean number of minutes required to completed intraoperative imaging during a surgical case
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Justis P Ehlers, MD, Cole Eye Institute, Cleveland Clinic, OH 44195

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-787

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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