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

Inclusion Criteria4

  • Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed.
  • Surgeons as research subjects: Adult (≥18 years old)
  • Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases
  • 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 Criteria3

  • 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.
  • Surgical patients (vitreoretinal surgery): Neonates (\< 4 weeks of age) and patients with any ocular disease that restricts the ability to perform OCT scanning.
  • 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.

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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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