Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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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