Peripheral Retina Robotically Aligned OCT Study (PR-RAOCT)

April 7, 2026 updated by: Duke University

Assistive Robotically Aligning Optical Coherence Tomography of the Retinal Periphery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Purpose and Objectives:

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 retinal periphery for breaks: indirect ophthalmoscopy with scleral depression, a procedure requiring the examiner to mechanically indent the eye at multiple locations and use an indirect ophthalmoscope and condensing lens to attempt to visualize the retina peripherally and over360°. The rationale for this project is that in addition to being extremely uncomfortable for the patient, this technique requires considerable skill with specialized training.

Furthermore, the exam does not create a direct record of the findings - the examiner must illustrate a guide map from memory for subsequent laser photocoagulation (LP) therapy utilizing this same manual technique. These objectives will be achieved by pursuing two specific aims: 1) Adapt a custom conical mirror contact lens and robotically aligning platform to optically access the peripheral retina with OCT and laser photocoagulation therapy; and 2) Validate peripheral retina robotically aligning OCT against scleral depressed exam in eyes with and without peripheral retinal breaks requiring treatment.

To validate our imaging technique, the investigators will conduct a powered study in eyes with and without known peripheral retina breaks comparing total number of detected peripheral retinal breaks per eye by Peripheral Retina Robotically Aligned OCT (PR-RAOCT) versus clinical exam. As a secondary outcome, the investigators will evaluate subject comfort level following each method. The investigators will recruit patients presenting at the Duke Eye Center with complaints of "flashers and floaters" and have undergone indirect ophthalmoscopy with scleral depression as part of their standard of care.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 - Healthy adult volunteers
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
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.
Other Names:
  • PR-RAOCT
Other: Likert Scales
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.
Experimental: Group 2 - Adult participants with "flashers and floaters"
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
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.
Other Names:
  • PR-RAOCT
Other: Likert Scales
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.
Experimental: Group 3 - Adult participants with flashers and floaters with no diagnosed peripheral retinal breaks
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
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.
Other Names:
  • PR-RAOCT
Other: Likert Scales
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.
Experimental: Group 4 - Adult participants with flashers and floaters with diagnosed peripheral retinal breaks
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
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.
Other Names:
  • PR-RAOCT
Other: Likert Scales
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of peripheral retinal break/s - clinical exam
Time Frame: Single imaging session (day 1)
Presence of peripheral retinal break as measured by clinical exam
Single imaging session (day 1)
Presence of peripheral retinal break/s - Optical Coherence Tomography (OCT)
Time Frame: Single imaging session (day 1)
Presence of peripheral retinal break as measured by OCT reading
Single imaging session (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Location of peripheral break
Time Frame: Single imaging session (day 1)
Peripheral break quadrant location (superior, inferior, temporal, nasal) for each exam as seen on OCT.
Single imaging session (day 1)
Comfort evaluation
Time Frame: Single session (day 1)
Participants will complete a survey evaluating relative comfort with each type of peripheral exam. Participants will rate three items on a 1(none) to 5(maximum) Likert scale. Lower Likert scores equate to a negative response (less comfortable) and a higher Likert score equates to a more positive response (more comfortable).
Single session (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Eye Institute (NEI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Cynthia A Toth, MD, Duke University Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115348
  • R21EY033959 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Disease

Clinical Trials on Peripheral retina robotically aligned optical coherence tomography (OCT) system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe