An observational study in Macular Holes, Epiretinal Membrane and Diabetic Retinopathy, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 4 Weeks and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Duke University · Observational
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 262 is above the median of 50 across 43 observational studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
262 subjects enrolled in 3 groups as follows:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
Also known as: MIOCT
Retinal and/or corneal microscope integrated optical coherence tomography image capture
Ability to capture images
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Year 1
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2018 (actual). Primary completion is estimated for Dec 2026, 99 months after the start.
Of 16 observational studies under Retinal Perforations, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 144. This study's planned 99 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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