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| ID | Type | Description | Link |
|---|---|---|---|
| U01EY028079 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal and/or corneal microscope integrated optical coherence tomography image capture | Ability to capture images | Year 1 |
| Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture | 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. | Year 1 |
| Retinal vascular flow on optical coherence tomography angiography (OCTA) versus fluorescein angiography | Cross correlation of ability to capture vessels and vessel pathology between OCTA and fluorescein angiographic images. | Year 1 |
| Assessment of change in pattern of ocular vascular flow before and after standard clinical surgical steps. | Presence or absence of change in ocular morphology in pattern of vascular flow compared to prior to surgical steps | Year 1 |
| Assessment of change in ocular morphology before and after standard surgical steps | Presence or absence of change in ocular morphology before and after standard surgical steps | Year 1 |
| Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output | Volume estimates from surgeons analyzed relative to the postoperative calculated volume from the intraoperative MIOCT | Year 1 |
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Inclusion Criteria:
Exclusion Criteria:
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262 subjects enrolled in 3 groups as follows:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neeru Sarin, MBBS | Contact | 919-668-5341 | neeru.sarin@duke.edu | |
| Michelle N McCall, MCAPM, BA | Contact | 919-684-0554 | michelle.mccall@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cynthia A Toth, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Eye Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| D019773 | Epiretinal Membrane |
| D003930 | Diabetic Retinopathy |
| D012163 | Retinal Detachment |
| D012164 | Retinal Diseases |
| D002386 | Cataract |
| D005134 | Eye Neoplasms |
| D013285 | Strabismus |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| D048909 |
| Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D007905 | Lens Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |