4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
NCT ID: NCT07024719
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2025-07-24
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing surgery for ocular disease
* Adults able and willing to give informed consent to participate in the study
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Carl Zeiss Meditec AG
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Cynthia A Toth, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Eye Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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. Erratum In: Biomed Opt Express. 2023 Sep 06;14(10):5047. doi: 10.1364/BOE.504316.
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.
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.
Other Identifiers
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Pro00117756
Identifier Type: -
Identifier Source: org_study_id
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