Robotic Eye Imaging for Corneal Topography

Overseen By Terry H. Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Hemodynamically unstable, Penetrating eye trauma

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

Compensation: Varies

Number of Visits: 1

93 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and test a robotically assisted imaging system for the front of the eye, enhancing eye care in emergency departments. Participants will have their eyes imaged using the Robotically Aligned Eye Imaging System, which could provide quicker and more accurate assessments. The trial compares this new method to the standard eye exams currently used in emergency settings. Adults experiencing eye issues like a foreign body sensation or red eye may be suitable for this trial, provided they do not require immediate emergency care for severe trauma. As an unphased trial, this study offers participants the chance to contribute to innovative advancements in eye care technology.

Will I have to stop taking my current medications?

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

What prior data suggests that this robotic eye imaging system is safe for corneal topography?

Research has shown that robotically aligned eye imaging systems, like the one being tested, are generally safe. These systems use optical coherence tomography (OCT), a method already known for its safety. OCT captures detailed images of the eye without contact.

Studies have found that this robotic imaging system can automatically adjust to the eye's position, preventing discomfort. The system avoids touching the eye, reducing the risk of irritation or infection.

Past research with similar robotic systems has reported no major side effects, suggesting that the treatment is well-tolerated. As the study is in an early phase, its main goal is to evaluate the system's functionality and safety. So far, evidence suggests a safe experience for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the robotic eye imaging system because it offers a cutting-edge approach to capturing detailed images of the cornea, unlike traditional manual imaging techniques. This system aligns automatically, potentially improving accuracy and consistency in emergency eye care settings. By streamlining the imaging process, it helps eye care professionals make quicker and more precise assessments, which can be crucial for timely treatment decisions.

What evidence suggests that the Robotically Aligned Eye Imaging System is effective for corneal topography?

Research has shown that the Robotically Aligned Eye Imaging System enhances eye images by tracking the patient's gaze, resulting in clearer and more precise images. This technology focuses on specific parts of the eye, producing better images and offering a wider view of the retina than traditional methods. In this trial, participants in the experimental arm will have their eyes imaged using this system, which automatically adjusts to movement, making the imaging process smoother and potentially more accurate. Overall, this technology aims to improve eye care by providing a more reliable and efficient method for capturing eye images. ^{1 2 6 7 8}

Who Is on the Research Team?

Anthony Kuo, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who come to the emergency department with eye problems that might involve the front part of the eye, like feeling something in their eye, redness, or pain.

Inclusion Criteria

I am experiencing eye issues like redness, pain, or feeling something in my eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants' eyes will be imaged with a robotically aligned eye imaging system to help eye care through the emergency department

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotically Aligned Eye Imaging System

Trial Overview The study is testing a new robotically controlled imaging system designed to examine the front section of the eye more effectively during emergency visits.

How Is the Trial Designed?

Group I: Experimental: Imaging patients Experimental Treatment 1 Intervention

Participants eyes will be imaged with a Robotically aligned eye imaging system to help eye care through the emergency department

Group II: Standard of care exam Active Control 1 Intervention

ED providers' standard of care exam

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The semiautomated surgical lens extraction using the OCT-integrated robotic system successfully achieved complete lens removal in 25 out of 30 postmortem pig eyes, indicating a high efficacy of the procedure.

Importantly, there were no instances of posterior capsule rupture or corneal leakage, suggesting a safe approach, although some minor complications like iris and corneal damage were noted, necessitating further refinements before full automation can be implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semiautomated optical coherence tomography-guided robotic surgery for porcine lens removal. Chen, CW., Francone, AA., Gerber, MJ., et al.[2021]

A new corneal topography method using optical coherence tomography (OCT) allows for direct measurement of the anterior cornea surface elevation from a single image, enhancing the precision of corneal imaging.

This innovative technique generates a detailed topographic map of the cornea by capturing multiple axial positions simultaneously, which could improve diagnostic capabilities in ophthalmic practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct corneal elevation measurements using multiple delay en face optical coherence tomography. Plesea, L., Podoleanu, AG.[2019]

A new robotic optical coherence tomography (OCT) system allows for comprehensive imaging of kidney microstructures, overcoming the limitations of traditional OCT devices that only assess small areas.

This system demonstrated high accuracy in tracking (0.0762±0.0727 mm) and successfully provided detailed images of kidney vasculature and structures, which could improve evaluations of kidney viability for transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large Area Kidney Imaging for Pre-transplant Evaluation using Real-Time Robotic Optical Coherence Tomography. Ma, X., Moradi, M., Ma, X., et al.[2023]

A new class of microsurgical instruments has been developed that integrates common path optical coherence tomography (CP-OCT) for enhanced precision in surgical procedures, particularly in eye surgery.

Initial tests with a prototype 25 gauge microsurgical pick showed promising capabilities, including safety features to prevent accidental collisions, consistent scanning distances, and targeted penetration of subsurface structures, demonstrating its potential for improved surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fiber optical coherence tomography microsurgical instruments for computer and robot-assisted retinal surgery. Balicki, M., Han, JH., Iordachita, I., et al.[2019]

A new algorithm for detecting and correcting eye motion during OCT-based corneal topography significantly improves measurement accuracy, achieving a 2-4 fold increase in repeatability compared to standard methods.

After applying the motion correction, the repeatability of key corneal measurements was very precise, with values of 0.14 D for mean power and around 0.24 D for astigmatism, demonstrating that this method enhances the reliability of OCT topography across different devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye motion correction algorithm for OCT-based corneal topography. Pavlatos, E., Huang, D., Li, Y.[2021]

A new robot-mounted optical coherence tomography (OCT) scanner has been developed that automates the alignment and orientation process, improving the ease of use for both operators and patients.

The system demonstrated high accuracy and precision in imaging, stabilizing images and allowing for targeted alignment at any gaze orientation within a 28° range, which enhances diagnostic capabilities in ophthalmology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotically aligned optical coherence tomography with 5 degree of freedom eye tracking for subject motion and gaze compensation. Ortiz, P., Draelos, M., Viehland, C., et al.[2022]

Traditional optical coherence tomography (OCT) systems can only image either the anterior segment or the retina of the eye, but not both simultaneously due to design and depth limitations.

New 'whole-eye' OCT systems have been developed that allow for comprehensive imaging of the entire eye, which can enhance applications like cataract surgery planning and myopia analysis by providing a more integrated view of ocular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Whole-Eye Optical Coherence Tomography Imaging. Kuo, AN., McNabb, RP., Izatt, JA.[2020]

A new robot-mounted optical coherence tomography (OCT) scanner allows for contactless imaging of the eyes without the need for operator intervention or head stabilization, making it easier to use in various settings.

The quality of images obtained from this robotic OCT scanner is comparable to traditional large clinical systems, potentially improving access to eye disease diagnosis and monitoring in non-specialist clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contactless optical coherence tomography of the eyes of freestanding individuals with a robotic scanner. Draelos, M., Ortiz, P., Qian, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8713666/

Robotically aligned optical coherence tomography with 5 ... Our results demonstrate that the system stabilized images and that the addition of gaze tracking and aiming allowed for region-of-interest specific alignment at ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06451068

Peripheral Retina Robotically Aligned OCT Study The long-term goal is to develop a system that provides 360° visualization of the peripheral retina replacing the current standard of care for evaluation of the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11828438/

Robotics and optical coherence tomography: current works ... This review paper surveys these recent developments at the intersection of OCT and robotics and organizes them by degree of integration and application.

4. researchgate.net researchgate.net/publication/361946164_Robotically-Aligned_Optical_Coherence_Tomography_with_Gaze_Tracking_for_Live_Image_Montaging_of_the_Retina

Robotically-Aligned Optical Coherence Tomography with ... RAOCT offers not just the maneuverability and workspace of handheld imaging but enhances it by incorporating automated alignment that can respond to motion more ...

5. dukespace.lib.duke.edu dukespace.lib.duke.edu/items/7297be1b-791a-4faf-a519-b92f636ee9b4

Robotically Aligned and Automatically Controlled Systems for ... RAOCT represents a novel technology that aims to provide an automated imaging alternative, reducing the reliance on tabletop or operator-driven OCT systems.

6. opg.optica.org opg.optica.org/boe/fulltext.cfm?uri=boe-16-2-578

Robotics and optical coherence tomography: current works ... Optical coherence tomography (OCT) is an interferometric technique for micron-level imaging in biological and non-biological contexts.

7. motion.cs.illinois.edu motion.cs.illinois.edu/papers/ICRA2019-Draelos-AutomaticOCT.pdf

Automatic Optical Coherence Tomography Imaging of ... We present a robotically-aligned OCT scanner capable of automatic eye imaging without chinrests. The scanner features eye tracking from fixed-base RGB-D cameras ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9882601/

Contactless, autonomous robotic alignment of optical ... We introduce contactless, autonomous robotic alignment of optical coherence tomography (RAOCT) for in vivo imaging of retinal disease.