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Intraoperative OCT Guidance of Intraocular Surgery II (MIOCT)

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ClinicalTrials.gov Identifier: NCT03713268
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Duke University

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 disease Intervention/treatment
Macular Holes Epiretinal Membrane Diabetic Retinopathy Retinal Detachment Retinal Disease Preretinal Fibrosis Cataract Ocular Tumor Strabismus Healthy Device: Microscope integrated optical coherence tomography

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

Group/Cohort Intervention/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 Name: 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 Name: 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 Name: MIOCT




Primary Outcome Measures :
  1. Retinal and/or corneal microscope integrated optical coherence tomography image capture [ Time Frame: Year 1 ]
    Ability to capture images

  2. Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Year 1 ]
    Volume estimates from surgeons analyzed relative to the postoperative calculated volume from the intraoperative MIOCT



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

262 subjects enrolled in 3 groups as follows:

  1. Healthy Controls: 50 subjects
  2. Surgeons as research subjects performing randomized testing in wet lab: 22 subjects
  3. Surgical patients as research subjects for application to ocular vitreoretinal and anterior segment surgery: 190 subjects
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713268


Contacts
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Contact: Neeru Sarin, MBBS 919-668-5341 neeru.sarin@duke.edu
Contact: Michelle N McCall, MCAPM, BA 919-684-0554 michelle.mccall@duke.edu

Locations
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United States, North Carolina
Duke University Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Michelle McCall    919-684-0544    mccal023@mc.duke.edu   
Contact: Neeru Sarin    9196685641    neeru.sarin@duke.edu   
Principal Investigator: Cynthia A Toth, MD         
Principal Investigator: Anthony Kuo, MD         
Sponsors and Collaborators
Duke University
National Eye Institute (NEI)
Investigators
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Principal Investigator: Cynthia A Toth, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03713268     History of Changes
Other Study ID Numbers: Pro00100437
U01EY028079 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
Microscope Integrated optical coherence tomography
MIOCT
OCT Angiography
OCTA
Additional relevant MeSH terms:
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Strabismus
Cataract
Retinal Diseases
Diabetic Retinopathy
Retinal Detachment
Retinal Perforations
Epiretinal Membrane
Lens Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases