4D microscope-integrated OCT imaging using the Zeiss Artevo 800 during eye surgery
Official title: First Use of Duke 4D Microscope Integrated OCT (MIOCT) Integrated Into Zeiss Artevo 800 Ophthalmic Surgical Microscope in the Operating Room
Run by Duke University · NCT07024719 · Data updated 2026-11-12
This pilot will try a 4D microscope-integrated OCT system on adults having eye surgery to see if it safely captures useful images of eye microanatomy during operations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | July 24, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07024719 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who are scheduled for clinically indicated anterior or posterior segment eye surgery at Duke and who can give informed consent are ideal candidates.
✕Probably not a fit
Patients with ocular conditions that prevent OCT scanning (for example dense media opacities that block imaging) or patients not undergoing surgery will likely not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-human pilot uses a 3D/4D OCT scanner integrated into a Zeiss Artevo 800 surgical microscope to collect intraoperative images during a range of anterior and posterior segment procedures. Up to 8 adult patients (target 5) undergoing clinically indicated eye surgery at Duke will have investigational imaging performed during their scheduled operations with no research treatments given. The team will compare intraoperative 4D MIOCT images to standard clinical imaging and medical record data, document ease of use and any safety issues, and measure volumes such as tracked subretinal injections from the OCT data. Findings will inform design of larger studies on accuracy, precision, and reproducibility of the system for surgical guidance and research imaging.
Why it matters
Potential benefit: If successful, the system could give surgeons real-time 3D/4D views of tiny eye structures during surgery, potentially improving visualization and guidance for delicate procedures.
How similar studies have gone: Other intraoperative and microscope-integrated OCT systems have demonstrated useful surgical imaging in prior work, but this is the first in-human pilot of this particular 4D integration and is therefore novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with any ocular disease that restricts the ability to perform OCT scanning
Where it's running
-
Duke University Eye Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Cynthia A Toth, MD — Duke University
- Study coordinator: Cynthia A Toth, MD
- Email: cynthia.toth@duke.edu
- Phone: 919-684-0544
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.