Intraoperative OCT Guidance of Intraocular Surger

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Observational

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

Participation Requirements

Sex: All

Minimum Age: 28 days

Healthy Volunteers: t

View:

• 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.

Locations

United States

North Carolina

Duke University Eye Center

RECRUITING

Durham

Contact Information

Primary

Neeru Sarin, MBBS

neeru.sarin@duke.edu

919-668-5341

Backup

Michelle N McCall, MCAPM, BA

michelle.mccall@duke.edu

919-684-0554

Time Frame

Start Date: 2018-09-30

Estimated Completion Date: 2027-05-31

Participants

Target number of participants: 262

Treatments

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).

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.

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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