4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07024719
Status
Recruiting
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Conditions

  • Corneal Diseases
  • Ocular Diseases
  • Retinal Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 4D MIOCT integrated into a Zeiss Artevo 800 — DEVICE
    4D MIOCT integrated into a Zeiss Artevo 800 surgical microscope with an add-on investigational 3D OCT scanner

Study Details

The study team will conduct the first in-human pilot studies using 4D MIOCT for imaging in the operating room. Building on the earlier integration and wet-lab validations, the researchers will assess the system's ease of use, safety, and visualization of intended structures during various anterior and posterior segment ophthalmic procedures.

Key Dates

Start date
Jul 24, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Group 1 - Imaging during ophthalmic surgery
    Research 4D MIOCT imaging will be performed in the operating room during clinically-indicated surgical procedures. Imaging will be of one or both eyes.

Primary Outcome Measure

4D MIOCT ease of use [ Time Frame: Standard of care visit - day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Eye CenterDurhamNorth Carolina27710
Michelle N McCall, MCAPM, BA
[email protected]
919-684-0544
Neeru Sarin, MD
[email protected]
919-668-5641
Cynthia A Toth, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University Eye Center· Durham, NC

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