NCT03713268

Intraoperative OCT Guidance of Intraocular Surgery II

Intraoperative OCT Guidance of Intraocular Surger

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 262 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Macular Holes
• Epiretinal Membrane
• Diabetic Retinopathy
• Retinal Detachment
• Retinal Disease
• Preretinal Fibrosis
• Cataract
• Ocular Tumor
• Strabismus
• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-30
• Primary completion: 2026-12-31
• Completion: 2027-05-31
• First posted: 2018-10-19
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study