Peripheral Retina Robotically Aligned OCT Study (PR-RAOCT)

Duke University

Status: Not yet enrolling

Conditions: Retinal Disease

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06451068

Pro00115348

R21EY033959 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 4 patient groups

Group 1 - Healthy adult volunteers

Experimental group

Description:

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

Treatment:

Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system

Other: Likert Scales

Group 2 - Adult participants with "flashers and floaters"

Experimental group

Description:

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

Treatment:

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 group

Description:

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)

Treatment:

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 group

Description:

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)

Treatment:

Device: Peripheral retina robotically aligned optical coherence tomography (OCT) system

Other: Likert Scales