4D MIOCT for Eye Diseases

(4D MIOCT Trial)

Overseen By Cynthia A Toth, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Ocular disease restricting OCT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging system called 4D MIOCT (4D Duke Microscope Integrated Optical Coherence Tomography) to improve visualization for eye doctors during surgeries. The goal is to ensure this tool is safe, easy to use, and provides clear images of the eye's structures. The trial is open to adults already scheduled for eye surgery who can agree to participate. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance surgical outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this 4D MIOCT is safe for imaging during ophthalmic surgery?

Research has shown that the 4D Duke Microscope Integrated Optical Coherence Tomography (4D MIOCT) system has undergone safety testing in eye surgeries. Studies have found that this system enhances doctors' vision during operations, reducing mistakes without causing harm. No reports have linked negative effects directly to the use of 4D MIOCT in surgeries. This suggests that 4D MIOCT is safe and well-tolerated for use in eye surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 4D Duke Microscope Integrated Optical Coherence Tomography (MIOCT) because it offers a cutting-edge way to enhance eye surgery. Unlike traditional imaging techniques, which provide two-dimensional views, this 4D method captures real-time, three-dimensional images of the eye during surgery. This allows surgeons to see incredibly detailed images, improving precision and potentially leading to better surgical outcomes. The ability to view the eye's structure in such detail during surgery could revolutionize how eye diseases are treated, making procedures safer and more effective.

What evidence suggests that 4D MIOCT is effective for imaging during ophthalmic surgery?

Studies have shown that the 4D Duke Microscope Integrated Optical Coherence Tomography (4D MIOCT) assists during eye surgeries by providing surgeons with a live, detailed view of the eye. This tool captures real-time, 3D images that help doctors make precise movements and avoid mistakes during surgery. In this trial, participants will undergo imaging with 4D MIOCT during clinically-indicated surgical procedures. Research indicates that using 4D MIOCT during procedures can lower the risk of complications. It has proven useful in surgeries for retinal and corneal diseases by offering a clear picture of the eye's structure. Early findings suggest this technology is safe and effective, making surgeries potentially safer and more successful. ^{1 2 4 6 7}

Who Is on the Research Team?

Cynthia A Toth, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals with various eye conditions such as retinal diseases and corneal disorders. Specific eligibility criteria are not provided, but typically participants would need to be suitable for ophthalmic procedures where the imaging technology will be used.

Inclusion Criteria

I am an adult who agrees to participate in this study.

I am having surgery for an eye condition.

I am 18 years old or older.

Exclusion Criteria

I have an eye condition that prevents OCT scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging during Surgery

Research 4D MIOCT imaging will be performed in the operating room during clinically-indicated surgical procedures.

1 day

1 visit (in-person)

Data Analysis

Data collected from the OCT systems will be analyzed offline for image processing and alternate visualizations.

2-4 weeks

Follow-up

Participants are monitored for any post-surgical outcomes and data comparison with existing clinical studies.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 4D Duke Microscope Integrated Optical Coherence Tomography

Trial Overview The study is testing a new imaging system called 4D MIOCT integrated into a Zeiss Artevo 800 microscope. It aims to evaluate its ease of use, safety, and effectiveness in visualizing structures during eye surgeries.

How Is the Trial Designed?

Group I: Group 1 - Imaging during ophthalmic surgery Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Carl Zeiss Meditec AG

Industry Sponsor

Trials

43

Recruited

7,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07024719

NCT07024719 | 4D Duke Microscope Integrated Optical ... The purpose of this project is to capture research images from microscope integrated Optical Coherence Tomography (MIOCT) integrated into a Zeiss Artevo 800 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6778454/

Four-dimensional microscope-integrated optical coherence ... 4D-MIOCT is useful for continuous monitoring of model subretinal surgery and may help avoid technique-related complications.

3. dukeeyecenter.duke.edu dukeeyecenter.duke.edu/news/intraoperative-4-d-microscope-integrated-oct

Intraoperative 4-D Microscope-Integrated OCT Intraoperative microscope-mounted spectral domain optical coherence tomography for evaluation of retinal anatomy during macular surgery.

4. nature.com nature.com/articles/srep31689

Live volumetric (4D) visualization and guidance of in vivo ... Minimally-invasive microsurgery has resulted in improved outcomes for patients. However, operating through a microscope limits depth ...

5. withpower.com withpower.com/trial/phase-retinal-diseases-6-2025-ea067

4D MIOCT for Eye Diseases ... 4D Duke Microscope Integrated Optical Coherence Tomography will have tolerable side effects & efficacy for patients with Retinal Disease, Corneal Diseases ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31090685/

Four-Dimensional Microscope-Integrated Optical Coherence ... Conclusions:: 4D-MIOCT is useful for continuous monitoring of model subretinal surgery and may help avoid technique-related complications. 4D-MIOCT can ...

7. researchgate.net researchgate.net/publication/333099790_Four-Dimensional_Microscope-Integrated_Optical_Coherence_Tomography_Guidance_in_a_Model_Eye_Subretinal_Surgery

(PDF) Four-Dimensional Microscope-Integrated Optical ... 4D-MIOCT visualization was essential to: monitor the extent of induced retinal detachment, guide the cannula tip and instrument maneuvers in the ...