Actively Recruiting

Age: 4Weeks +
All Genders
Healthy Volunteers
ID03713268

Intraoperative OCT Guidance of Intraocular Surgery to Evaluate Live Imaging During Eye Procedures

Led by Duke University · Updated on 2025-10-06

262

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to develop and evaluate a new technology called microscope integrated optical coherence tomography (MIOCT) that provides live, three-dimensional imaging during eye surgeries. The goal is to improve how surgeries are performed and their outcomes by offering better visualization, which could enable new types of eye and microsurgeries currently limited by existing imaging methods. The study involves several groups: healthy adults with normal eye health who will have images taken to test and improve the MIOCT system, eye surgeons who will use the device during practice surgeries to assess its usefulness, and adult and minor patients undergoing actual eye surgeries where MIOCT imaging will be used during the procedures. The device uses a near-infrared light beam integrated into the surgical microscope and does not touch the eye. Participants will be involved through imaging sessions or during their surgeries, depending on their group. Researchers will collect multiple detailed images of the retina, cornea, and blood vessels, and compare these images before and after surgical steps. They will assess image quality, vascular flow, eye structure changes, and fluid volume related to retinal detachment. The study includes follow-up to monitor these outcomes, with participation lasting according to the imaging or surgical schedule.

CONDITIONS

Brief Title

Intraoperative OCT Guidance of Intraocular Surgery II

Who Can Participate

Age: 4Weeks +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults with normal eyes, including mild refractive error and non-significant cataract
  • Adult surgeons and surgical trainees aged 18 years or older
  • Patients undergoing vitreoretinal surgery or examination under anesthesia for vitreoretinal diseases
  • Adults and children older than 4 months undergoing elective minimally invasive glaucoma surgery, ocular surface surgery, or strabismus surgery
Not Eligible

You will not qualify if you...

  • Healthy controls with any eye disease limiting OCT scanning or conflicts of interest with investigators
  • Neonates younger than 4 weeks and patients with eye diseases restricting OCT scanning in vitreoretinal surgery group
  • Pediatric patients under 18 years for corneal and cataract surgery studies
  • No specific exclusions for surgeon research subjects

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Varies based on participant group and procedure

Participants undergo imaging with the microscope integrated optical coherence tomography (MIOCT) system to capture detailed images of the eye's microanatomy.

1 to multiple imaging sessions depending on cohort

Implementation

Duration - During the surgical procedure

During clinically indicated vitreoretinal and anterior segment surgical procedures, the microscope integrated optical coherence tomography system is used to obtain real-time images to guide surgery and evaluate ocular morphology and vascular flow.

Imaging performed intraoperatively during surgery

Trial Site Locations

Total: 1 location

1

Duke University Eye Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

N

Neeru Sarin, MBBS

M

Michelle N McCall, MCAPM, BA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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