Intraoperative OCT Guidance of Intraocular Surgery (MIOCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01588041
First received: April 26, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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
Eye Manifestations

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative OCT Guidance of Intraocular Surgery

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Test and provide feedback on the intraoperative system both in laboratory and then in the operating room. [ Time Frame: 8.5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 802
Study Start Date: September 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588041

Contacts
Contact: Cynthia A Toth, MD 919-684-5631 cynthia.toth@duke.edu
Contact: Michelle N McCall, MCAPM, BA 919-684-0544 michelle.mccall@duke.edu

Locations
United States, North Carolina
Duke University Eye Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Cynthia A Toth, MD    919-684-5631    cynthia.toth@duke.edu   
Contact: Michelle McCall, MCAPM, BA    919-684-0544    michelle.mccall@duke.edu   
Principal Investigator: Cynthia A Toth, MD         
Sub-Investigator: Paul S Hahn, MD, PhD         
Sub-Investigator: Anthony Kuo, MD         
United States, Ohio
Cole Eye Institute at the Cleveland Clinic Lemer College of Medicine Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Sunil Srivastava, MD    216-636-2286    srivass2@ccf.org   
Contact: Ehlers Justis, MD    (216) 636-2286    ehlersj1@yahoo.com   
Principal Investigator: Sunil K Srivastava, MD         
Sub-Investigator: Justis P Ehlers, MD         
Sub-Investigator: William J Dupps, Jr., MD, PhD         
Sponsors and Collaborators
Duke University
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
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01588041     History of Changes
Other Study ID Numbers: Pro00016827, 1R01EY023039-01
Study First Received: April 26, 2012
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Microscope mounted SDOCT

Additional relevant MeSH terms:
Eye Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014