Recruiting

Handheld OCT

Sponsor:

Duke University

Code:

NCT06841575

Conditions

Eye Diseases

Retinal Disease

Glaucoma

Optic Nerve Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Auto-aligned OCT

Study Details

Brief summary:

The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.

Conditions

Eye Diseases

Retinal Disease

Glaucoma

Optic Nerve Diseases

Study ID

NCT06841575

Start date

Mar 23, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Group 1: Healthy adult volunteers
  • 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
  • Group 2: Adult patients in ophthalmology clinics
  • Health care provider, knowledgeable of protocol, agrees that study personnel could contact the subject
  • Subject is able and willing to consent to study participation
  • Subject is more than 18 years of age and is a patient in the Duke Eye Center ophthalmology clinics
  • Group 3: Pediatric participants in ophthalmology clinics
  • Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian
  • Parent/legal guardian is able and willing to consent to study participation
  • Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center

Exclusion Criteria:

  • Group 1: Healthy adult volunteers
  • Students or employees under direct supervision of the investigators
  • Subjects with prior problems with pupil dilation
  • Pregnant woman if receiving dilating drops
  • Group 2: Adult patients in ophthalmology clinics
  • Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
  • Group 3: Pediatric participants in ophthalmology clinics
  • Parent/legal guardian unwilling or unable to provide consent
  • Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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=20)

experimental: Group 2: Adult patients in ophthalmology clinics

Adult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20)

experimental: Group 3: Pediatric patients in ophthalmology clinics

Minor participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=10)

Interventions

Auto-aligned OCT

Swept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time

Primary outcome measure

  • Number of participants with abnormal retinal microanatomy [ Time Frame: Up to 4 single imaging sessions at clinical visits over 2 years ]
  • Severity of abnormal retinal microanatomy [ Time Frame: Up to 4 single imaging sessions at clinical visits over 2 years ]
  • Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysis [ Time Frame: Up to 4 single imaging sessions at clinical visits over 2 years ]

Central Contacts and Locations

Central contacts

Xi Chen, MD, PhD

(919) 684-8434xi2.chen@duke.edu

Michelle N McCall, MCAPM, BA

(919) 684-0544michelle.mccall@duke.edu

Locations

Duke University Eye Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michelle N McCall, MCAPM, BA

919-684-0544michelle.mccall@duke.edu

Neeru Sarin, MD

(919) 668-5641neeru.sarin@duke.edu

More Information

Sponsor

Duke University

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • Optical Coherence Tomography (OCT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.