NCT05530460

Brief Summary

The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2024

Completed
Last Updated

February 17, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

September 1, 2022

Last Update Submit

February 13, 2026

Conditions

Optical Coherence Tomography of Retina

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device

    measured by: ability to see clearly defined and recognizable structures of the retina with the low-cost OCT device.

    during study procedures (30 minutes)

Secondary Outcomes (1)

  • Contrast-to-Noise Ratio (CNR)

    during study procedures (30 minutes)

Study Arms (1)

OCT Imaging Performance Testing (1A)

EXPERIMENTAL

Compare performance characteristics of custom OCT device with commercial OCT device.

Device: retinal imaging with low-cost OCT deviceDevice: retinal imaging with commercial OCT device

Interventions

retinal imaging with low-cost OCT deviceDEVICE

Retinal imaging with low-cost OCT device

OCT Imaging Performance Testing (1A)
retinal imaging with commercial OCT deviceDEVICE

retinal imaging with commercial OCT device

OCT Imaging Performance Testing (1A)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to provide informed consent

You may not qualify if:

  • potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20/40
  • eyes that have had intraocular surgery, other than cataract surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

  • Adam Wax, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 7, 2022

Study Start

March 22, 2024

Primary Completion

May 17, 2024

Study Completion

May 17, 2024

Last Updated

February 17, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)