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

NCT07024719 | Recruiting FDA Device

• 1 other identifier: Pro00117756
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 4D MIOCT ease of use

  Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)

  Standard of care visit - day 1

Secondary Outcomes (3)

• Surgical workflow

  Standard of care visit - day 1

• Presence of microanatomy as measured by 4D MIOCT image reading

  Standard of care visit - day 1

• Presence of abnormal microanatomy as measured by 4D MIOCT

  Standard of care visit - day 1

Study Arms (1)

Group 1 - Imaging during ophthalmic surgery

EXPERIMENTAL

Research 4D MIOCT imaging will be performed in the operating room during clinically-indicated surgical procedures. Imaging will be of one or both eyes.

Device: 4D MIOCT integrated into a Zeiss Artevo 800

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

Group 1 - Imaging during ophthalmic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with any ocular disease that restricts the ability to perform OCT scanning

Sponsors & Collaborators

• Duke University: lead
• Carl Zeiss Meditec AG: collaborator

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (9)

• Carrasco-Zevallos OM, Keller B, Viehland C, Shen L, Seider MI, Izatt JA, Toth CA. Optical Coherence Tomography for Retinal Surgery: Perioperative Analysis to Real-Time Four-Dimensional Image-Guided Surgery. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT37-50. doi: 10.1167/iovs.16-19277.

  PMID: 27409495 BACKGROUND

• Carrasco-Zevallos OM, Viehland C, Keller B, Draelos M, Kuo AN, Toth CA, Izatt JA. Review of intraoperative optical coherence tomography: technology and applications [Invited]. Biomed Opt Express. 2017 Feb 21;8(3):1607-1637. doi: 10.1364/BOE.8.001607. eCollection 2017 Mar 1.

  PMID: 28663853 BACKGROUND

• Viehland C, Keller B, Carrasco-Zevallos OM, Nankivil D, Shen L, Mangalesh S, Viet du T, Kuo AN, Toth CA, Izatt JA. Enhanced volumetric visualization for real time 4D intraoperative ophthalmic swept-source OCT. Biomed Opt Express. 2016 Apr 12;7(5):1815-29. doi: 10.1364/BOE.7.001815. eCollection 2016 May 1.

  PMID: 27231623 BACKGROUND

• Carrasco-Zevallos OM, Keller B, Viehland C, Shen L, Waterman G, Todorich B, Shieh C, Hahn P, Farsiu S, Kuo AN, Toth CA, Izatt JA. Live volumetric (4D) visualization and guidance of in vivo human ophthalmic surgery with intraoperative optical coherence tomography. Sci Rep. 2016 Aug 19;6:31689. doi: 10.1038/srep31689.

  PMID: 27538478 BACKGROUND

• Chen X, Viehland C, Carrasco-Zevallos OM, Keller B, Vajzovic L, Izatt JA, Toth CA. Microscope-Integrated Optical Coherence Tomography Angiography in the Operating Room in Young Children With Retinal Vascular Disease. JAMA Ophthalmol. 2017 May 1;135(5):483-486. doi: 10.1001/jamaophthalmol.2017.0422.

  PMID: 28384676 BACKGROUND

• Li JD, Viehland C, Dhalla AH, Trout R, Raynor W, Kuo AN, Toth CA, Vajzovic LM, Izatt JA. Visualization of surgical maneuvers using intraoperative real-time volumetric optical coherence tomography. Biomed Opt Express. 2023 Jun 29;14(7):3798-3811. doi: 10.1364/BOE.488967. eCollection 2023 Jul 1.

  PMID: 37497507 BACKGROUND

• Trout RM, Viehland C, Li JD, Raynor W, Dhalla AH, Vajzovic L, Kuo AN, Toth CA, Izatt JA. Methods for real-time feature-guided image fusion of intrasurgical volumetric optical coherence tomography with digital microscopy. Biomed Opt Express. 2023 Jun 13;14(7):3308-3326. doi: 10.1364/BOE.488975. eCollection 2023 Jul 1.

  PMID: 37497493 BACKGROUND

• Li JD, Raynor W, Dhalla AH, Viehland C, Trout R, Toth CA, Vajzovic LM, Izatt JA. Quantitative measurements of intraocular structures and microinjection bleb volumes using intraoperative optical coherence tomography. Biomed Opt Express. 2022 Dec 19;14(1):352-366. doi: 10.1364/BOE.483278. eCollection 2023 Jan 1.

  PMID: 36698674 BACKGROUND

• Toth CA. Optical Coherence Tomography and Eye Care. N Engl J Med. 2023 Oct 19;389(16):1526-1529. doi: 10.1056/NEJMcibr2307733. Epub 2023 Sep 21. No abstract available.

  PMID: 37732605 BACKGROUND

MeSH Terms

Conditions

Corneal Diseases; Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Cynthia A Toth, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia A Toth, MD

CONTACT

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

Michelle N McCall, MCAPM, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 17, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)