Optical Coherence Tomography for Retinal Surgery: Perioperative Analysis to Real-Time Four-Dimensional Image-Guided Surgery.
Oscar M Carrasco-Zevallos, Brenton Keller, Christian Viehland...
https://pubmed.ncbi.nlm.nih.gov/27409495Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07024719
First Use of Duke 4D Microscope Integrated OCT (MIOCT) Integrated Into Zeiss Artevo 800 Ophthalmic Surgical Microscope in the Operating Room
Led by Duke University · Updated on 2026-01-16
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
C
Carl Zeiss Meditec AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eye's structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.
CONDITIONS
Brief Title
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult participants 18 years of age and older
- Patients undergoing surgery for ocular disease
- Adults able and willing to give informed consent to participate in the study
You will not qualify if you...
- Patients with any ocular disease that restricts the ability to perform OCT scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of surgery
Participants undergo clinically-indicated ophthalmic surgery during which research imaging with the 4D MIOCT integrated into a Zeiss Artevo 800 surgical microscope is performed to capture detailed images of the eye.
1 visit (in-person, during surgery)
Monitoring
Duration - Up to 3 months prior to surgery
Researchers collect and analyze clinical data and imaging from the participant's medical record including up to three eye care visits prior to surgery and compare these to the intraoperative images.
No additional visits required for study purposes
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
C
Cynthia A Toth, MD
M
Michelle N McCall, MCAPM, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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Published Research Related To This Trial
Review of intraoperative optical coherence tomography: technology and applications [Invited].
Oscar M Carrasco-Zevallos, Christian Viehland, Brenton Keller...
https://pubmed.ncbi.nlm.nih.gov/28663853Enhanced volumetric visualization for real time 4D intraoperative ophthalmic swept-source OCT.
Christian Viehland, Brenton Keller, Oscar M Carrasco-Zevallos...
https://pubmed.ncbi.nlm.nih.gov/27231623Live volumetric (4D) visualization and guidance of in vivo human ophthalmic surgery with intraoperative optical coherence tomography.
O M Carrasco-Zevallos, B Keller, C Viehland...
https://pubmed.ncbi.nlm.nih.gov/27538478Microscope-Integrated Optical Coherence Tomography Angiography in the Operating Room in Young Children With Retinal Vascular Disease.
Xi Chen, Christian Viehland, Oscar M Carrasco-Zevallos...
https://pubmed.ncbi.nlm.nih.gov/28384676Visualization of surgical maneuvers using intraoperative real-time volumetric optical coherence tomography.
Jianwei D Li, Christian Viehland, Al-Hafeez Dhalla...
https://pubmed.ncbi.nlm.nih.gov/37497507Methods for real-time feature-guided image fusion of intrasurgical volumetric optical coherence tomography with digital microscopy.
Robert M Trout, Christian Viehland, Jianwei D Li...
https://pubmed.ncbi.nlm.nih.gov/37497493Quantitative measurements of intraocular structures and microinjection bleb volumes using intraoperative optical coherence tomography.
Jianwei D Li, William Raynor, Al-Hafeez Dhalla...
https://pubmed.ncbi.nlm.nih.gov/36698674Optical Coherence Tomography and Eye Care.
Cynthia A Toth
https://pubmed.ncbi.nlm.nih.gov/37732605