Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07024719

First Use of Duke 4D Microscope Integrated Optical Coherence Tomography with Zeiss Artevo 800 Surgical Microscope Observational Imaging Study During Ophthalmic Surgery for Ocular Diseases

Led by Duke University · Updated on 2026-01-16

5

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

C

Carl Zeiss Meditec AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope. The study focuses on adults undergoing eye surgery for corneal, retinal, or other ocular diseases. The goal is to assess how easy and safe the 4D MIOCT system is to use during various anterior and posterior segment eye surgeries and to visualize the eye's structures effectively. The 4D MIOCT device is integrated into the Zeiss Artevo 800 surgical microscope and includes an investigational 3D OCT scanner. This imaging system will be used during the participants' clinically-indicated eye surgeries without any additional treatment or surgical intervention for research purposes. The study is observational, capturing images during standard ophthalmic microsurgery and comparing them to other clinical images obtained as part of usual care. Participants will have their eye images recorded during surgery using the 4D MIOCT device. Researchers will also review medical records from up to three previous eye care visits to gather clinical data, including ocular health and prior treatments. The images and data will be analyzed after surgery to evaluate the device's performance and explore whether it provides new information beyond existing clinical imaging. There is no extra risk to participants beyond their scheduled surgery.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Duke University Eye Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

C

Cynthia A Toth, MD

M

Michelle N McCall, MCAPM, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Optical Coherence Tomography for Retinal Surgery: Perioperative Analysis to Real-Time Four-Dimensional Image-Guided Surgery.

Oscar M Carrasco-Zevallos, Brenton Keller, Christian Viehland...

https://pubmed.ncbi.nlm.nih.gov/27409495

Live volumetric (4D) visualization and guidance of in vivo human ophthalmic surgery with intraoperative optical coherence tomography.

O M Carrasco-Zevallos, B Keller, C Viehland...

https://pubmed.ncbi.nlm.nih.gov/27538478

Microscope-Integrated Optical Coherence Tomography Angiography in the Operating Room in Young Children With Retinal Vascular Disease.

Xi Chen, Christian Viehland, Oscar M Carrasco-Zevallos...

https://pubmed.ncbi.nlm.nih.gov/28384676

Visualization of surgical maneuvers using intraoperative real-time volumetric optical coherence tomography.

Jianwei D Li, Christian Viehland, Al-Hafeez Dhalla...

https://pubmed.ncbi.nlm.nih.gov/37497507

Methods for real-time feature-guided image fusion of intrasurgical volumetric optical coherence tomography with digital microscopy.

Robert M Trout, Christian Viehland, Jianwei D Li...

https://pubmed.ncbi.nlm.nih.gov/37497493

Quantitative measurements of intraocular structures and microinjection bleb volumes using intraoperative optical coherence tomography.

Jianwei D Li, William Raynor, Al-Hafeez Dhalla...

https://pubmed.ncbi.nlm.nih.gov/36698674