MedTrace Logo

Intraoperative OCT Guidance of Intraocular Surgery II

NCT03713268 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 262

Last updated 2025-10-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Cynthia A Toth, MD · Duke University

Eligibility

Min Age
4 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2026-12-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03713268 on ClinicalTrials.gov