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MIOCT: Intraoperative OCT Guidance of Intraocular Surgery

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01588041
Collaborator
National Eye Institute (NEI) (NIH)
269
Enrollment
2
Locations
107.2
Duration (Months)
134.5
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    269 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Intraoperative OCT Guidance of Intraocular Surgery
    Study Start Date :
    Sep 1, 2009
    Actual Primary Completion Date :
    Aug 8, 2018
    Actual Study Completion Date :
    Aug 8, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Vitreoretinal Interface Disease Group

    A minimum of 50 subjects with vitreoretinal interface disease will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits.
    Macular Hole Group

    A minimum of 50 subjects with macular hole with be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits.
    Retinal Detachment Group

    A minimum of 50 subjects with retinal detachment will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits.
    Diabetic Retinopathy Group

    A minimum of 50 subjects with diabetic retinopathy will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits.
    Rare Related Macular Disease Group

    Up to 70 subjects with rare related macular diseases will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits.
    Generation 2 MIOCT Transition Group

    80 of the subjects recruited in years 1 through 5 (40 normal, 40 diseased) will be imaged with both the generation 1 MIOCT and the generation 2 MIOCT systems prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits.
    Endothelial Keratoplasty Group

    150 subjects undergoing Descemet Stripping Endothelial Keratoplasty (DSEK) will be imaged with MIOCT at the conclusion of the surgical procedure and may be imaged during follow-up visits.
    Anterior Lamellar Keratoplasty Group

    150 subjects undergoing Deep Anterior Lamellar Keratoplasty (DALK) will be imaged with MIOCT at the conclusion of the surgical procedure and may be imaged during follow-up visits.

    Outcome Measures

    Primary Outcome Measures

    1. Test and provide feedback on the intraoperative system both in laboratory and then in the operating room. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Eye Center Durham North Carolina United States 27705
    2 Cole Eye Institute at the Cleveland Clinic Lemer College of Medicine Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • Duke University
    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Cynthia A Toth, MD, Duke University Health System, Department of Ophthalmology
    • Principal Investigator: Joseph A Izatt, PhD, Duke University Department of Biomedical Engineering

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT01588041
    Other Study ID Numbers:
    • Pro00016827
    • R01EY023039
    First Posted:
    Apr 30, 2012
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Duke University
    Microscope mounted SDOCT
    Additional relevant MeSH terms:
    Eye Manifestations

    Study Results

    No Results Posted as of Jan 31, 2022