Clinical trial NCT07024719: 4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Official title: First Use of Duke 4D Microscope Integrated OCT (MIOCT) Integrated Into Zeiss Artevo 800 Ophthalmic Surgical Microscope in the Operating Room
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Corneal Diseases
Retinal Diseases
Ocular Diseases
Keywords: Microscope integrated OCT
intraoperative OCT
optical coherence tomography (OCT)
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Carl Zeiss Meditec AG
First posted: 2025-06-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed description: The purpose of this project is to capture research images from microscope integrated Optical Coherence Tomography (MIOCT) integrated into a Zeiss Artevo 800 surgical microscope with an add-on investigational 3D OCT scanner (hereafter called the 4D MIOCT) in participants undergoing clinically-indicated surgical procedures for a range of ocular diseases. The researchers will evaluate normal and abnormal microanatomy of the eye, image during surgical procedures, and track subretinal injections for therapeutic delivery during surgery (volumes measured/analyzed from the OCT images after surgery).

This study is an observational imaging study with no treatment interventions for research purposes. The population is 5 adult ophthalmic surgical patients scheduled for eye surgery at Duke Eye Center, Durham. Up to 8 patients may be enrolled due to potential for surgery scheduling changes that would not allow research imaging on a surgery day for up to 3 patients. Research activities consist of investigational 4D MIOCT integrated into Zeiss Artevo 800 imaging of the eyes during surgery and collection of clinical data and other imaging from the participant's medical record, clinical visit and surgical procedure.

Additional imaging of the participant's eye performed for clinical care will be extracted from the medical record for comparison to the intraoperative images. In this initial pilot, comparisons will enable design of future studies for accuracy, precision and reproducibility of the research device in eye surgery.

For study participants there is no additional risk to the participant beyond what is normal for their ophthalmic surgery. No medications or surgical interventions/activities will be performed for research purposes.

Images will be captured during the standard care ophthalmic microsurgery.

This research will utilize the data gathered during OCT imaging performed as described above. The data collected from the OCT systems will be analyzed offline to allow for image processing and alternate visualizations of the area under study. The data gathered from 4D MIOCT imaging will be compared to existing clinical studies (performed as part of standard of care) on the participant, should they exist, for the purpose of identifying whether new information is gained by 4D MIOCT. Researchers will review the participant's Medical Record for up to three eye care visits prior to surgery and record information related to ocular health, eye examinations and imaging and prior ophthalmic treatment. No additional clinical studies will be performed for the purpose of this study.

Eligibility 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

Primary outcomes:
measure: 4D MIOCT ease of use
timeFrame: Standard of care visit - day 1
Secondary outcomes:
measure: Surgical workflow
timeFrame: Standard of care visit - day 1
measure: Presence of microanatomy as measured by 4D MIOCT image reading
timeFrame: Standard of care visit - day 1
measure: Presence of abnormal microanatomy as measured by 4D MIOCT
timeFrame: Standard of care visit - day 1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Cynthia A Toth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.