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

58 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Peripheral retina robotically aligned OCT system for retinal disease?

Research shows that using OCT (optical coherence tomography) in robotic eye surgeries can help doctors see the retina better, making surgeries more precise and potentially improving outcomes. This suggests that the robotic OCT system could be effective in treating retinal diseases by providing clearer images of the peripheral retina. ^{1 2 3 4 5}

Is the Robotic OCT System for Retinal Disease safe for humans?

The research does not provide specific safety data for humans using the Robotic OCT System for Retinal Disease, but it does mention that robotic devices can help reduce hand tremors and improve precision in eye surgeries, which suggests potential safety benefits. ^{1 2 6 7 8}

How is the robotic OCT system treatment for retinal disease different from other treatments?

The robotic OCT system for retinal disease is unique because it uses a robotic scanner to autonomously and contactlessly image the eyes, allowing for precise alignment and motion reduction without the need for head stabilization. This system enhances the visualization of peripheral retinal structures, which can be challenging with traditional methods, and provides real-time feedback during surgery to improve accuracy. ^{1 2 3 9 10}

What is the purpose of this trial?

Optical coherence tomography (OCT) is a 3D imaging technology that has seen wide adoption within ophthalmology. However, optical access to the retinal periphery remains a challenge for conventional OCT systems. The study team plans to innovate peripheral retinal OCT imaging technology by first developing the first robotic OCT system capable of autonomously assisting the operator during imaging of the human peripheral retina using 3D active tracking and compensation and then by developing of the first OCT system designed for treatment of the retinal periphery.

Research Team

Cynthia A Toth, MD

Principal Investigator

Duke University Eye Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of peripheral OCT imaging using a novel integrated SLO ultra-widefield imaging swept-source OCT device. [2021]

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

NOVEL METHOD FOR VISUALIZING PERIPHERAL RETINAL STRUCTURES WITH MICROSCOPE-INTEGRATED OPTICAL COHERENCE TOMOGRAPHY. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of an Instrument-Integrated OCT-Based Distance Sensor for Robotic Vitreoretinal Surgery. [2022]

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

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

5. Korea (South) pubmed.ncbi.nlm.nih.gov

OCT-guided hyaloid release for vitreomacular traction syndrome. [2021]

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

Artifacts in automatic retinal segmentation using different optical coherence tomography instruments. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Wide field of view swept-source optical coherence tomography for peripheral retinal disease. [2018]

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

OCT-guided Robotic Subretinal Needle Injections: A Deep Learning-Based Registration Approach. [2023]

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

Evaluation of microsurgical tasks with OCT-guided and/or robot-assisted ophthalmic forceps. [2020]

10. England pubmed.ncbi.nlm.nih.gov

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