4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
NCT07024719 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-01-16
Summary
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.
Conditions
- Corneal Diseases
- Retinal Diseases
- Ocular Diseases
Interventions
- DEVICE
-
4D MIOCT integrated into a Zeiss Artevo 800
4D MIOCT integrated into a Zeiss Artevo 800 surgical microscope with an add-on investigational 3D OCT scanner
Sponsors & Collaborators
-
Carl Zeiss Meditec AG
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Cynthia A Toth, MD · Duke University
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-24
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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