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
Led by Duke University · Updated on 2026-01-16
5
Participants Needed
1
Research Sites
62 weeks
Total Duration
D
Duke University
Lead Sponsor
C
Carl Zeiss Meditec AG
Collaborating Sponsor
Researchers are evaluating a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope. The study focuses on adults undergoing eye surgery for corneal, retinal, or other ocular diseases. The goal is to assess how easy and safe the 4D MIOCT system is to use during various anterior and posterior segment eye surgeries and to visualize the eye's structures effectively. The 4D MIOCT device is integrated into the Zeiss Artevo 800 surgical microscope and includes an investigational 3D OCT scanner. This imaging system will be used during the participants' clinically-indicated eye surgeries without any additional treatment or surgical intervention for research purposes. The study is observational, capturing images during standard ophthalmic microsurgery and comparing them to other clinical images obtained as part of usual care. Participants will have their eye images recorded during surgery using the 4D MIOCT device. Researchers will also review medical records from up to three previous eye care visits to gather clinical data, including ocular health and prior treatments. The images and data will be analyzed after surgery to evaluate the device's performance and explore whether it provides new information beyond existing clinical imaging. There is no extra risk to participants beyond their scheduled surgery.
CONDITIONS
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
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Total: 1 location
1
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
C
Cynthia A Toth, MD
M
Michelle N McCall, MCAPM, BA
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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Oscar M Carrasco-Zevallos, Brenton Keller, Christian Viehland...
https://pubmed.ncbi.nlm.nih.gov/27409495Oscar M Carrasco-Zevallos, Christian Viehland, Brenton Keller...
https://pubmed.ncbi.nlm.nih.gov/28663853Christian Viehland, Brenton Keller, Oscar M Carrasco-Zevallos...
https://pubmed.ncbi.nlm.nih.gov/27231623O M Carrasco-Zevallos, B Keller, C Viehland...
https://pubmed.ncbi.nlm.nih.gov/27538478Xi Chen, Christian Viehland, Oscar M Carrasco-Zevallos...
https://pubmed.ncbi.nlm.nih.gov/28384676Jianwei D Li, Christian Viehland, Al-Hafeez Dhalla...
https://pubmed.ncbi.nlm.nih.gov/37497507Robert M Trout, Christian Viehland, Jianwei D Li...
https://pubmed.ncbi.nlm.nih.gov/37497493Jianwei D Li, William Raynor, Al-Hafeez Dhalla...
https://pubmed.ncbi.nlm.nih.gov/36698674Cynthia A Toth
https://pubmed.ncbi.nlm.nih.gov/37732605