Clinical trial NCT01588041: Intraoperative OCT Guidance of Intraocular Surgery
Official title: Intraoperative OCT Guidance of Intraocular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Manifestations
Keywords: Microscope mounted SDOCT
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2012-04-30
Enrollment: 269
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 722 subjects identified and recruited from the clinics of Duke Eye Center and Cole Eye Institute. Of those, there will be 500 retina subjects and 222 anterior segment subjects. Control subjects may include employees and students of both institutions.

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 description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Test and provide feedback on the intraoperative system both in laboratory and then in the operating room.
timeFrame: 8.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Cleveland
country: United States
facility: Cole Eye Institute at the Cleveland Clinic Lemer College of Medicine
state: Ohio
Study officials:
affiliation: Duke University Health System, Department of Ophthalmology
name: Cynthia A Toth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Department of Biomedical Engineering
name: Joseph A Izatt, PhD
role: PRINCIPAL_INVESTIGATOR
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