NCT04790890

Brief Summary

Optical Coherence Tomography (OCT) image data will be evaluated for image quality and used to test post-processing algorithms to improve detection sensitivity for ophthalmic diseases.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
25mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress71%
Mar 2021Jun 2028

First Submitted

Initial submission to the registry

March 3, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

6.8 years

First QC Date

March 3, 2021

Last Update Submit

March 7, 2026

Conditions

Healthy Volunteers

Keywords

Optical Coherence TomographyOphthalmologyRetina

Outcome Measures

Primary Outcomes (1)

  • Novel Ophthalmic Diagnostics using Optical Coherence Tomography

    This study will develop novel OCT technology for improved diagnostic sensitivity in ophthalmology. Specifically, we will develop novel OCT imaging and image-processing methods to improve imaging speed and quality. Successful completion of this project will improve clinical diagnostics of ophthalmic diseases. Pre-clinical validation of system performance and ergonomics is a valuable step is clinical imaging technology development. We will evaluate imaging performance for system iterations on next-generation ophthalmic OCT imaging technologies over current-generation imaging systems on healthy adult volunteers prior to clinical translation. While system resolution, contrast, and speed can be (and will be) evaluated using calibration standards and phantoms, in vivo human imaging in healthy subjects is necessary to establish a baseline for system performance and image quality prior to clinical translation.

    Subjects enrolled in the study may periodically be asked to participate in follow-up imaging during the duration of the study. These follow-up sessions will be optional through study completion, an average of 2 years.

Interventions

Optical coherence tomography (OCT)DEVICE

Optical coherence tomography (OCT) is a non-invasive imaging test which uses light waves to take cross-section pictures of the retina.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subject population includes both males and females. All study subjects will be \>18 years with no pre-existing ophthalmic conditions. All subjects included in the study will be informed of their rights and voluntary nature of the study. The study and informed consent form will be reviewed with subjects by the principal investigator (Dr. Yuankai Kenny Tao). Subjects will have the opportunity to read and review the consent form and ask any questions. Informed consent will be obtained for all subjects.

You may qualify if:

  • Healthy adults (\>18 years) with no pre-existing ophthalmic conditions

You may not qualify if:

  • Children or adults unable to consent
  • Any volunteers with history of ocular disease/injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Related Publications (4)

  • LIA,

    BACKGROUND

  • Fechtig DJ, Grajciar B, Schmoll T, Blatter C, Werkmeister RM, Drexler W, Leitgeb RA. Line-field parallel swept source MHz OCT for structural and functional retinal imaging. Biomed Opt Express. 2015 Feb 4;6(3):716-35. doi: 10.1364/BOE.6.000716. eCollection 2015 Mar 1.

    PMID: 25798298BACKGROUND

  • Spahr H, Hillmann D, Hain C, Pfaffle C, Sudkamp H, Franke G, Huttmann G. Imaging pulse wave propagation in human retinal vessels using full-field swept-source optical coherence tomography. Opt Lett. 2015 Oct 15;40(20):4771-4. doi: 10.1364/OL.40.004771.

    PMID: 26469616BACKGROUND

  • Yanagi Y, Inoue Y, Jang WD, Kadonosono K. A2e mediated phototoxic effects of endoilluminators. Br J Ophthalmol. 2006 Feb;90(2):229-32. doi: 10.1136/bjo.2005.076711.

    PMID: 16424539BACKGROUND

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 10, 2021

Study Start

March 8, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)