NCT05210478

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

63
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
37mo left

Started Jan 2027

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

January 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
4.9 years until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

January 13, 2022

Last Update Submit

March 12, 2026

Conditions

Corneal Transplantation

Keywords

Optical Coherence TomographyOphthalmologyCornea

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
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 diagnosis of cornea transplant (keratoplasty). 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 (Christine Shieh, MD. 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:

  • Adults (\>18 years) with diagnosis of cornea transplant (keratoplasty)

You may not qualify if:

  • Children or adults unable to consent
  • Healthy adults (\>18 years) without diagnosis of cornea transplant (keratoplasty)

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

Conditions

Corneal Diseases

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Central Study Contacts

Marybeth Carter, BS

CONTACT

615-936-1639marybeth.l.carter@vumc.org

Crystal Nicholson, BS

CONTACT

615-936-0971crystal.nicholson@vumc.org

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

January 13, 2022

First Posted

January 27, 2022

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)