Peripheral Retina Robotically Aligned OCT Study

NCT06451068 | Withdrawn FDA Device

• 2 other identifiers: Pro00115348R21EY033959
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinal Disease

Keywords

Optical Coherence Tomography (OCT)

Outcome Measures

Primary Outcomes (2)

• Presence of peripheral retinal break/s - Optical Coherence Tomography (OCT)

  Presence of peripheral retinal break as measured by OCT reading

  Single imaging session (day 1)

• Presence of peripheral retinal break/s - clinical exam

  Presence of peripheral retinal break as measured by clinical exam

  Single imaging session (day 1)

Secondary Outcomes (2)

• Location of peripheral break

  Single imaging session (day 1)

• Comfort evaluation

  Single session (day 1)

Study Arms (4)

Group 1 - Healthy adult volunteers

EXPERIMENTAL

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

Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system; Other: Likert Scales

Group 2 - Adult participants with "flashers and floaters"

EXPERIMENTAL

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

Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system; Other: Likert Scales

Group 3 - Adult participants with flashers and floaters with no diagnosed peripheral retinal breaks

EXPERIMENTAL

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)

Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system; Other: Likert Scales

Group 4 - Adult participants with flashers and floaters with diagnosed peripheral retinal breaks

EXPERIMENTAL

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)

Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system; Other: Likert Scales

Interventions

Peripheral retina robotically aligned optical coherence tomography (OCT) system DEVICE

To visualize the full 360° of the retinal periphery (from equator to the more anterior ora serrata), investigators developed and redesigned a conical mirror contact lens and our non-contact robotically aligning platform to deliver OCT to the peripheral retina. The peripheral retina robotically aligned OCT (PR-RAOCT) system is built around a 6-axis cooperative robot (UR5e, Universal Robots), using our previously developed RAOCT control software.

Also known as: PR-RAOCT

Group 1 - Healthy adult volunteers; Group 2 - Adult participants with "flashers and floaters"; Group 3 - Adult participants with flashers and floaters with no diagnosed peripheral retinal breaks; Group 4 - Adult participants with flashers and floaters with diagnosed peripheral retinal breaks

Likert Scales OTHER

Survey evaluating relative comfort with each type of peripheral exam (scleral depression vs. PR-RAOCT). Participants will rate 3 items on a 1 (non) to 5 (maximum) Likert scale: overall discomfort, physical pain, and photophobia for each exam.

Group 1 - Healthy adult volunteers; Group 2 - Adult participants with "flashers and floaters"; Group 3 - Adult participants with flashers and floaters with no diagnosed peripheral retinal breaks; Group 4 - Adult participants with flashers and floaters with diagnosed peripheral retinal breaks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able and willing to consent to study participation
• Subject is more than 18 years of age
• Healthy adult volunteers without known ocular issues other than refractive error

You may not qualify if:

• Subject is unwilling or unable to provide consent
• Subject is less than 18 years of age
• Students or employees under direct supervision of the investigators
• Subjects with eye trauma, infection of the anterior ocular tissues or corneal conditions like keratoconus, Peter's anomaly, corneal edema, dense cataracts obscuring the retina and dense capsule opacities in pseudophakes
• The investigators will not exclude subjects based on eyes being phakic, pseudo-phakic, or aphakic.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Eye Institute (NEI): collaborator

MeSH Terms

Conditions

Retinal Diseases

Interventions

Tomography, Optical Coherence; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Cynthia A Toth, MD

  Duke University Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to a group based on ocular history/diagnosis. Each participant will receive the same intervention.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 10, 2024
• Study Start: January 1, 2026
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)