Intraoperative OCT Guidance of Intraocular Surgery

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 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.

This study will facilitate future quality improvement processes based on intraoperative data
matched to postoperative outcomes. Intraoperative OCT feedback will revolutionize
communication in surgical research, clinical communication, surgeon training and continuing
education, and will provide measurable data regarding disease patterns and intraoperative
response, novel instrument and adjuvant use.

This study will prospectively examine the surgical utility of MIOCT in retinal and anterior
segment surgery. A total of 722 subjects will be enrolled at 2 sites, Duke Eye Center and
Cole Eye Institute. Of those, there will be 500 retina subjects and 222 anterior segment
subjects. There will be a small number of normal subjects, who are not undergoing eye
surgery, enrolled in this portion of this study for non-surgical study of the MIOCT system
imaging, particularly for Generation 2 (G2) MIOCT. Rate of recruitment: 460 retina subjects
will be enrolled at the rate of approximately 115 per year (~57 per year at both Duke and
Cole) for years 1-4 and approximately 40 subjects will be enrolled in year 5 (adding up to a
total of 500 subjects).

Inclusion criteria

1. subjects undergoing surgery for vitreoretinal interface disease

2. subjects undergoing surgery for macular hole

3. subjects undergoing surgery for retinal detachment

4. subjects undergoing surgery for diabetic retinopathy with macular edema and/or
traction detachments

5. subjects undergoing surgery for epiretinal membranes

6. subjects undergoing surgery for rare related macular diseases like myopic schisis.

7. subjects undergoing endothelial keratoplasty or anterior lamellar keratoplasty

8. subjects with normal ocular pathology enrolled as controls

Exclusion criteria:

1. Any ocular disease that restricts the ability to perform MIOCT scanning.