Peripheral Retina Robotically Aligned OCT Study

Retinal Disease Clinical Trial

— PR-RAOCT  

Official title:

Assistive Robotically Aligning Optical Coherence Tomography of the Retinal Periphery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451068
• Other study ID #: Pro00115348
• Secondary ID: R21EY033959
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Cynthia A Toth, MD
• Phone: (919) 684-9170
• Email: cynthia.toth[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Duke University Eye Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Eye Institute (NEI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Presence of peripheral retinal break/s - clinical exam	Presence of peripheral retinal break as measured by clinical exam	Single imaging session (day 1)
Secondary	Location of peripheral break	Peripheral break quadrant location (superior, inferior, temporal, nasal) for each exam as seen on OCT.	Single imaging session (day 1)
Secondary	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).	Single session (day 1)