Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment5 (estimated)
SponsorDuke University
Academic / other
Locations1 site (Durham, North Carolina)
StatusRecruiting
StartedJuly 24, 2025
Main results expectedOctober 2027
Study endsOctober 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07024719 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.