NCT06841575

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

February 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

February 19, 2025

Last Update Submit

March 23, 2026

Conditions

GlaucomaOptic Nerve DiseasesEye DiseasesRetinal Disease

Keywords

Optical Coherence Tomography (OCT)

Outcome Measures

Primary Outcomes (3)

  • Number of participants with abnormal retinal microanatomy

    Measured by optical coherence tomography (OCT) reading.

    Up to 4 single imaging sessions at clinical visits over 2 years

  • Severity of abnormal retinal microanatomy

    Measured by optical coherence tomography (OCT) reading.

    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

    Measured by optical coherence tomography (OCT) analysis.

    Up to 4 single imaging sessions at clinical visits over 2 years

Study Arms (3)

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=20)

Device: Auto-aligned OCT

Group 2: Adult patients in ophthalmology clinics

EXPERIMENTAL

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

Device: Auto-aligned OCT

Group 3: Pediatric patients in ophthalmology clinics

EXPERIMENTAL

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

Device: Auto-aligned OCT

Interventions

Auto-aligned OCTDEVICE

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

Group 1: Healthy adult volunteersGroup 2: Adult patients in ophthalmology clinicsGroup 3: Pediatric patients in ophthalmology clinics

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Eye DiseasesRetinal DiseasesGlaucomaOptic Nerve Diseases

Condition Hierarchy (Ancestors)

Ocular HypertensionCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Xi Chen, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Chen, MD, PhD

CONTACT

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

Michelle N McCall, MCAPM, BA

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 24, 2025

Study Start

March 23, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)