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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop and test a robotically assisted imaging system for the front of the eye with a goal of helping eye care through the emergency department.

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 data supports the effectiveness of the treatment Robotic Eye Imaging System for corneal topography?

Research shows that the Robotic Eye Imaging System, which uses optical coherence tomography (OCT), can capture high-quality images of the eye without needing a trained operator or head stabilization. This system can automatically align with the eye and correct for motion, improving the accuracy and repeatability of corneal measurements, making it effective for diagnosing and monitoring eye conditions. ^{1 2 3 4 5}

Is the Robotic Eye Imaging System safe for human use?

The research on robotic eye imaging systems, including robot-mounted OCT scanners, shows that they can safely perform contactless imaging of the eyes without needing head stabilization, similar to traditional clinical systems. These systems have been tested on human subjects and are designed to improve imaging accuracy and stability, suggesting they are generally safe for human use. ^{1 2 3 6 7}

How is the Robotic Eye Imaging System treatment different from other treatments for corneal topography?

The Robotic Eye Imaging System is unique because it uses a robot-mounted optical coherence tomography (OCT) scanner that automatically aligns with the eye, allowing for contactless imaging without the need for head stabilization. This system compensates for eye motion and gaze, providing more accurate and repeatable corneal topography measurements compared to traditional methods. ^{1 2 3 5 8}

Research Team

Anthony Kuo, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Contactless optical coherence tomography of the eyes of freestanding individuals with a robotic scanner. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Robotically aligned optical coherence tomography with 5 degree of freedom eye tracking for subject motion and gaze compensation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Eye motion correction algorithm for OCT-based corneal topography. [2021]

4. China pubmed.ncbi.nlm.nih.gov

Advances in Whole-Eye Optical Coherence Tomography Imaging. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Large Area Kidney Imaging for Pre-transplant Evaluation using Real-Time Robotic Optical Coherence Tomography. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Single fiber optical coherence tomography microsurgical instruments for computer and robot-assisted retinal surgery. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Semiautomated optical coherence tomography-guided robotic surgery for porcine lens removal. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Direct corneal elevation measurements using multiple delay en face optical coherence tomography. [2019]