Clinical Trial: Intraoperative OCT Guidance of Intraocular Surgery

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Intraoperative OCT Guidance of Intraocular Surgery

Brief Summary: The purpose of this study is to investigate the use of optical coherence tomography imaging integrated with an operating microscope (MIOCT) in ophthalmic surgeries.

Detailed Summary:

Optical Coherence Tomography (OCT) is used to capture reproducible ocular morphology and cross-sectional tissue measurements in-vivo in a rapid, non-invasive, non-contact manner. It has displaced ophthalmoscopy and stereo photography for clinical assessment and documentation of retinal microanatomy including thickness, cystoid structures, subretinal fluid and retinal traction.(1) Spectral Domain Optical Coherence Tomography (SDOCT) has the speed and resolution required for real-time noninvasive three-dimensional imaging of critical pathology.

While modern ophthalmic surgery has benefited from rapid advances in instrumentation and techniques (2-6), the basic principles of the stereo zoom operating microscope have not changed (except for increased automation) since the 1930's. (7-9) The ability to better resolve tissue microanatomy through real-time micro-imaging would have a dramatic impact on ophthalmic surgeon's capabilities, foster the development of new surgical techniques, and potentially improve surgical outcomes.

Complementary to microscope integrated OCT (MIOCT) testing, we use a commercial hand-held SDOCT instrument (Bioptigen, Inc.) during pauses in both anterior segment and retinal surgery to document surgical process.

While both the handheld instrument and Duke's Generation 1 (G1) MIOCT prototype have demonstrated that high-quality OCT imaging is possible during surgery, in both cases control of the OCT scan location and display of the real-time image data are managed on the OCT system console, located up to several feet from the surgeon. Thus, the potential dramatic impact of this technology on ophthalmic surgery is constrained by its limited integration with the surgical environment. The primary technical goal of this project is to address this issue through no
Sponsor: Duke University

Current Primary Outcome: Test and provide feedback on the intraoperative system both in laboratory and then in the operating room. [ Time Frame: 8.5 years ]

The primary outcome of this project is to integrate optical coherence tomography (OCT) with the surgical environment through novel advances in OCT technology, automated tracking of surgical instruments and tools, and fusion of OCT controls, images and measurements into a seamless interface for the surgeon.


Original Primary Outcome: Test and provide feedback on the intraoperative system both in laboratory and then in the operating room. [ Time Frame: 2 years ]

Surgeon use of an intraoperative surgical microscope SDOCT (SM) system requires 3 functional components to be tested first in the laboratory and then in human subjects: 1) SDOCT image capture from the SM system, 2) SDOCT image capture integrated with surgical maneuvers, 3) SDOCT imaging provided to the surgical assistant for heads-up real time use. Three vitreoretinal surgeons will perform independent testing of the novel feedback systems and provide input and feedback to the engineering design team as the intraoperative microscope-mounted system is developed.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Duke University

Dates:
Date Received: April 26, 2012
Date Started: September 2009
Date Completion: January 2018
Last Updated: August 2, 2016
Last Verified: August 2016