Retinal DiseasePR-RAOCTNCT06451068
Peripheral Retina Robotically Aligned OCT Study
A study testing Peripheral retina robotically aligned optical coherence tomography (OCT) system and Likert Scales in people with Retinal Disease, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Peripheral retina robotically aligned optical coherence tomography (OCT) system and Likert Scales
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Retinal Disease
- Being tested
- Peripheral retina robotically aligned optical coherence tomography (OCT) system, Likert Scales
- Keywords
- Optical Coherence Tomography (OCT)
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral retina robotically aligned optical coherence tomography (OCT) systemDevice
Also called PR-RAOCT
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.
Likert ScalesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system; Other: Likert Scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of peripheral retinal break/s - Optical Coherence Tomography (OCT)
Presence of peripheral retinal break as measured by OCT reading
Measured: Single imaging session (day 1)
Presence of peripheral retinal break/s - clinical exam
Presence of peripheral retinal break as measured by clinical exam
Measured: Single imaging session (day 1)
Secondary outcomes (2)
Location of peripheral break
Peripheral break quadrant location (superior, inferior, temporal, nasal) for each exam as seen on OCT.
Measured: Single imaging session (day 1)
Comfort evaluation
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).
Measured: Single session (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study startJan 2026 (estimated)
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Why it stopped: This study involved building an assistive robotically aligning optical coherence tomography system. The device is not ready for human use so enrollment was never opened. The study is closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to a group based on ocular history/diagnosis. Each participant will receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Cynthia A Toth, MD, Principal investigator, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451068
- Sponsor's protocol ID
- Pro00115348
- Other IDs
- R21EY033959
- Acronym
- PR-RAOCT
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Robotically Aligning Optical Coherence Tomography of the Retinal Periphery
- ClinicalTrials.gov ID
- NCT06451068
- Acronym / sponsor ID
- PR-RAOCT / Pro00115348
- Conditions
- Retinal Disease
- Keywords
- Optical Coherence Tomography (OCT)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study involved building an assistive robotically aligning optical coherence tomography system. The device is not ready for human use so enrollment was never opened. The study is closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Study start
- Jan 2026 (estimated)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be assigned to a group based on ocular history/diagnosis. Each participant will receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Healthy adult volunteers | Experimental | Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system, Other: Likert ScalesHealthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=7) |
| Group 2 - Adult participants with "flashers and floaters" | Experimental | Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system, Other: Likert ScalesAdult participants recruited from the patient population of Duke Eye Center with complaints of "flashers and floaters" undergoing clinical examination (n=7) |
| Group 3 - Adult participants with flashers and floaters with no diagnosed peripheral retinal breaks | Experimental | Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system, Other: Likert ScalesAdult 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 4 - Adult participants with flashers and floaters with diagnosed peripheral retinal breaks | Experimental | Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system, Other: Likert ScalesAdult 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral retina robotically aligned optical coherence tomography (OCT) systemAlso: PR-RAOCTTo 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. | Device | 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 ScalesSurvey 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. | Other | 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 |
Primary outcome
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
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
2 secondary outcomes
Location of peripheral break
Time frame: Single imaging session (day 1)
Comfort evaluation
Time frame: Single session (day 1)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Screening for Research Participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia A Toth, MD principal investigator
Duke University Eye Center
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral retina robotically aligned optical coherence tomography (OCT) system and Likert Scales in people with Retinal Disease, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of peripheral retinal break/s - Optical Coherence Tomography (OCT) (time frame: Single imaging session (day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.