Robotic OCT System for Retinal Disease

(PR-RAOCT Trial)

Overseen By Michelle McCall, MCAPM, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Eye trauma, corneal conditions, dense cataracts, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to develop a new robotic imaging system, the Peripheral Retina Robotically Aligned OCT System, to improve the viewing and treatment of the peripheral retina, the outer edge of the eye's back layer. This advanced technology helps doctors see more clearly, especially in areas difficult to reach with current tools. The trial includes healthy volunteers and individuals experiencing "flashers and floaters" (visual disturbances like seeing spots or lines) with or without peripheral retinal breaks (small tears or holes in the retina). Participants who have experienced these visual disturbances and can consent might be a good fit. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance 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. It seems to focus on eye health, so it might not require changes to other medications, but it's best to check with the study team.

What prior data suggests that the peripheral retina robotically aligned OCT system is safe?

Research has shown that the robotically aligned OCT system is a useful tool for capturing images of the eyes. Studies have demonstrated its success in imaging various eye conditions. However, specific safety information for humans using this robotic OCT system is not yet available.

The study is in the "Not Applicable" phase, indicating that the technology remains in the early stages of research. While this does not directly confirm its safety, early trials often aim to understand the technology's function and potential effects. Consequently, detailed information on tolerance or possible side effects may not yet be available. Prospective participants should discuss any safety concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the robotic OCT system for retinal disease because it offers a cutting-edge method to evaluate the peripheral retina with precision. Unlike traditional eye exams that rely on manual techniques, this system uses robotic alignment to capture detailed images of the retina's outer edges, which are often hard to assess. This could lead to earlier and more accurate detection of issues like retinal breaks, potentially improving patient outcomes by catching problems that might be missed with standard imaging techniques.

What evidence suggests that this robotic OCT system is effective for retinal disease?

Research has shown that using OCT (optical coherence tomography) in eye surgeries enhances the clarity of the retina, making surgeries more precise and safer. This trial will evaluate a new robotic OCT system designed to improve the view of the retina's outer edges, which are typically hard to see with regular OCT. Participants will be divided into groups, including healthy volunteers and those with "flashers and floaters," to assess the system's effectiveness. Early findings suggest that this system can provide a complete 360° view of the retina's outer areas, potentially replacing current methods used for eye exams. This new approach could lead to better diagnosis and treatment of eye diseases. With this technology, doctors might catch problems earlier and treat them more effectively. ^{1 2 4 6 7}

Who Is on the Research Team?

Cynthia A Toth, MD

Principal Investigator

Duke University Eye Center

Are You a Good Fit for This Trial?

This trial is for individuals with retinal disease. Participants should be able to undergo OCT imaging and interact with the new robotic system designed for detailed retina scans. Specific inclusion and exclusion criteria are not listed, but typically these would detail health conditions or factors that qualify or disqualify a person from participating.

Inclusion Criteria

Subject is able and willing to consent to study participation

I am older than 18 years.

I am healthy with no eye problems except for needing glasses or contacts.

Exclusion Criteria

Subject is unwilling or unable to provide consent

I am under 18 years old.

Students or employees under direct supervision of the investigators

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Session

Participants undergo a single imaging session using Peripheral Retina Robotically Aligned OCT and clinical exam to detect peripheral retinal breaks

1 day

1 visit (in-person)

Comfort Evaluation

Participants complete a survey evaluating relative comfort with each type of peripheral exam

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects or additional findings post-imaging session

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral retina robotically aligned OCT system

Trial Overview The study is testing a new robotically aligned OCT system specifically aimed at capturing detailed images of the peripheral retina, which has been hard to access with conventional methods. The effectiveness will likely be measured using Likert Scales to assess satisfaction or image quality.

How Is the Trial Designed?

Group I: Group 4 - Adult participants with flashers and floaters with diagnosed peripheral retinal breaks Experimental Treatment 2 Interventions

Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" and a clinical examination showing one or more breaks in the peripheral retinal (n=22)

Group II: Group 3 - Adult participants with flashers and floaters with no diagnosed peripheral retinal breaks Experimental Treatment 2 Interventions

Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" and a clinical examination showing no breaks in the peripheral retina (n=22)

Group III: Group 2 - Adult participants with "flashers and floaters" Experimental Treatment 2 Interventions

Adult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" undergoing clinical examination (n=7)

Group IV: Group 1 - Healthy adult volunteers Experimental Treatment 2 Interventions

Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=7)

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

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 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. 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 ...

2. withpower.com withpower.com/trial/phase-retinal-diseases-8-2024-02cae

Robotic OCT System for Retinal Disease (PR-RAOCT Trial) Research shows that using OCT (optical coherence tomography) in robotic eye surgeries can help doctors see the retina better, making surgeries more precise and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12108957/

Recent Optical Coherence Tomography (OCT) Innovations for ... In glaucoma, OCT measures retinal nerve fiber layer thickness, aiding in the early detection of optic nerve damage [12]. Despite its importance ...

4. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2770042

Robotically Aligned OCT Imaging with Clinically Relevant ... Methods : We developed a custom robotically mounted retinal OCT system with a swept source (λ0=1043nm±72nm; 100 kHz) providing 30° FOV on the retina. To ...

5. researchgate.net researchgate.net/publication/361738878_Widefield_Optical_Coherence_Tomography_in_Pediatric_Retina_A_Case_Series_of_Intraoperative_Applications_Using_a_Prototype_Handheld_Device

Widefield Optical Coherence Tomography in Pediatric Retina The development of wider field OCT systems thus has the potential to improve the diagnosis and management of myriad diseases in both adult and pediatric retina.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10038849/

Robotic, optical coherence tomography retinal imaging for ... Key findings of this study are: 1) robotically acquired OCT was an effective tool for imaging a broad range of posterior eye abnormalities in ED ...

7. reporter.nih.gov reporter.nih.gov/search/5xY25bCmdEmh4k-5RObWXA/project-details/10811072

Project Details - NIH RePORTER Our research group has pioneered the invention of a robotically-aligned OCT (RAOCT) system capable of imaging both the anterior and posterior eye with active ...