Intraoperative OCT Guidance of Intraocular Surgery II

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT03713268
Status
Recruiting
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Conditions

  • Cataract
  • Diabetic Retinopathy
  • Epiretinal Membrane
  • Healthy
  • Macular Holes
  • Ocular Tumor
  • Preretinal Fibrosis
  • Retinal Detachment
  • Retinal Disease
  • Strabismus

Eligibility Criteria

Sex
ALL
Age
4 Weeks - N/A
Healthy Volunteers
Accepted

Interventions

  • Microscope integrated optical coherence tomography — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2018
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
262 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Eye CenterDurhamNorth Carolina27710
Michelle McCall
[email protected]
919-684-0544
Neeru Sarin
[email protected]
9196685641
Cynthia A Toth, MD (PRINCIPAL_INVESTIGATOR)
Anthony Kuo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Duke University Eye Center· Durham, NC

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