RecruitingNCT03713268

Intraoperative OCT Guidance of Intraocular Surgery II

Intraoperative OCT Guidance of Intraocular Surger


Sponsor

Duke University

Enrollment

262 participants

Start Date

Sep 30, 2018

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 4 Weeks

Plain Language Summary

Simplified for easier understanding

This study is evaluating how intraoperative optical coherence tomography (OCT) — a type of real-time high-resolution imaging — can improve the precision and outcomes of eye surgery. OCT uses light waves to take cross-sectional pictures of the eye's structures with extraordinary detail. Surgeons currently operate looking through a microscope, but OCT can provide a layer of visualization that helps guide delicate maneuvers in both the front and back of the eye. Four groups participate: healthy volunteers (to establish normal imaging parameters), surgeons as research subjects, patients undergoing vitreoretinal surgery (back of the eye), and patients undergoing anterior segment procedures like glaucoma, corneal, or strabismus surgery. The study spans all ages from infants (4 weeks and older) to adults. You may be eligible if: - You are 4 weeks of age or older - You are a healthy volunteer, a surgeon, or a patient scheduled for eye surgery (vitreoretinal, glaucoma, corneal surface, or strabismus surgery) You may NOT be eligible if: - You are a healthy volunteer with an eye disease preventing OCT scanning - You are a neonate (under 4 weeks) - You are a pediatric patient needing corneal or cataract surgery (that sub-study is adults only) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMicroscope 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.


Locations(1)

Duke University Eye Center

Durham, North Carolina, United States

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NCT03713268


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