MIOCT: Intraoperative OCT Guidance of Intraocular Surgery II

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03713268
Collaborator
National Eye Institute (NEI) (NIH)
262
Enrollment
1
Location
68
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Microscope integrated optical coherence tomography

Study Design

Study Type:
Observational
Anticipated Enrollment :
262 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intraoperative OCT Guidance of Intraocular Surger
Actual Study Start Date :
Sep 30, 2018
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

ArmIntervention/Treatment
Healthy (ocular health) participants

Adult subjects with normal, ocular health will be enrolled to evaluate and obtain multiple images from the microscope integrated optical coherence tomography system for reproducibility testing in humans, provide feedback to engineers, and verify that the system functions to produce high quality images of the desired areas of the eye after ex vivo development before surgical use. Each healthy subject will be imaged by the MIOCT system. There will be no surgery or intervention on these healthy volunteer subjects. We anticipate that a portion of the volunteer subjects would have repeat imaging (e.g. for reproducibility testing).

Device: Microscope integrated optical coherence tomography
This is translational study in which subjects will either be imaged with a microscope integrated optical coherence tomography (MIOCT) system or they will use MIOCT during surgical procedures. OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, cornea, optic nerve head and retinal blood vessels. The MIOCT has been integrated into the surgical microscope used in retinal and anterior segment surgeries so it does not touch the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the patient is not disturbed by the light.
Other Names:
  • MIOCT
  • Surgeons as research subjects

    Duke Eye Center surgical trainees (residents and fellows), attending surgeons, and surgeons from other medical institutions will be enrolled as subjects as we will test their performance with and without microscope integrated optical coherence tomography and with and without advances in 4D MIOCT in model surgeries in the research wet lab to better understand the utility of specific aspects and of this next generation MIOCT as a whole for specific anterior segment and retinal surgical tasks.

    Device: Microscope integrated optical coherence tomography
    This is translational study in which subjects will either be imaged with a microscope integrated optical coherence tomography (MIOCT) system or they will use MIOCT during surgical procedures. OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, cornea, optic nerve head and retinal blood vessels. The MIOCT has been integrated into the surgical microscope used in retinal and anterior segment surgeries so it does not touch the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the patient is not disturbed by the light.
    Other Names:
  • MIOCT
  • Surgical patients

    Adult and minor (> 4 months of age) surgical patients will be enrolled to evaluate and obtain multiple images from the microscope integrated optical coherence tomography system during clinically indicated vitreoretinal and anterior segment surgical procedures.

    Device: Microscope integrated optical coherence tomography
    This is translational study in which subjects will either be imaged with a microscope integrated optical coherence tomography (MIOCT) system or they will use MIOCT during surgical procedures. OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, cornea, optic nerve head and retinal blood vessels. The MIOCT has been integrated into the surgical microscope used in retinal and anterior segment surgeries so it does not touch the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the patient is not disturbed by the light.
    Other Names:
  • MIOCT
  • Outcome Measures

    Primary Outcome Measures

    1. Retinal and/or corneal microscope integrated optical coherence tomography image capture [Year 1]

      Ability to capture images

    2. Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture [Year 1]

      Quality of MIOCT images scored based on standard microanatomy and ability to detect presence or absence of ocular pathologies based on review by a masked grader.

    3. Retinal vascular flow on optical coherence tomography angiography (OCTA) versus fluorescein angiography [Year 1]

      Cross correlation of ability to capture vessels and vessel pathology between OCTA and fluorescein angiographic images.

    4. Assessment of change in pattern of ocular vascular flow before and after standard clinical surgical steps. [Year 1]

      Presence or absence of change in ocular morphology in pattern of vascular flow compared to prior to surgical steps

    5. Assessment of change in ocular morphology before and after standard surgical steps [Year 1]

      Presence or absence of change in ocular morphology before and after standard surgical steps

    6. Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output [Year 1]

      Volume estimates from surgeons analyzed relative to the postoperative calculated volume from the intraoperative MIOCT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed.

    2. Surgeons as research subjects: Adult (≥18 years old)

    3. Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases

    4. Surgical patients (anterior segment surgery-glaucoma, ocular surface or strabismus requiring extraocular muscle surgery): Include both adults and children. Patient undergoing primary, elective minimally invasive glaucoma surgery, ocular surface surgery, or strabismus surgery.

    Exclusion Criteria:
    1. Healthy controls: Any ocular disease that restricts the ability to perform OCT scanning. Conflict of interest with investigators/study personnel, e.g. a student in the lab of an investigator.

    2. Surgeons as research subjects: no specific exclusion criteria.

    3. Surgical patients (vitreoretinal surgery): Neonates (< 4 weeks of age) and patients with any ocular disease that restricts the ability to perform OCT scanning.

    4. Surgical patients (anterior segment surgery-corneal and cataract diseases): Pediatric patients: The cornea and cataract surgery studies will be restricted to adults (≥ 18 years). Children do not have cataract surgery typically by residents and therefore would not fit our study design. Similarly pediatric corneal transplants are very rare.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Duke University Eye CenterDurhamNorth CarolinaUnited States27710

    Sponsors and Collaborators

    • Duke University
    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Cynthia A Toth, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT03713268
    Other Study ID Numbers:
    • Pro00100437
    • U01EY028079
    First Posted:
    Oct 19, 2018
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Duke University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 8, 2021