4D microscope-integrated OCT imaging using the Zeiss Artevo 800 during eye surgery
First Use of Duke 4D Microscope Integrated OCT (MIOCT) Integrated Into Zeiss Artevo 800 Ophthalmic Surgical Microscope in the Operating Room
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07024719 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.