Recruiting

4D MIOCT

Sponsor:

Duke University

Code:

NCT07024719

Conditions

Corneal Diseases

Retinal Diseases

Ocular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

4D MIOCT integrated into a Zeiss Artevo 800

Study Details

Brief 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

Study ID

NCT07024719

Start date

Jul 24, 2025

Status verified date

Jan, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Cynthia A Toth, MD

919-684-0544cynthia.toth@duke.edu

Michelle N McCall, MCAPM, BA

919-684-0544michelle.mccall@duke.edu

Locations

Duke University Eye Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michelle N McCall, MCAPM, BA

919-684-0544michelle.mccall@duke.edu

Neeru Sarin, MD

919-668-5641neeru.sarin@duke.edu

Principal Investigator:

Cynthia A Toth, MD

More Information

Sponsor

Duke University

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Microscope integrated OCT
  • intraoperative OCT
  • optical coherence tomography (OCT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-16.