Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea (iOCT-Cornea)

March 5, 2024 updated by: Christine Shieh, Vanderbilt University Medical Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Optical coherence tomography (OCT) is an established technology for ophthalmic diagnosis which can perform noncontact, noninvasive, real time, cross-sectional imaging of the retina and anterior eye. OCT has displaced ophthalmoscopy and stereo-photography as the gold-standard for clinical assessment and documentation of retinal microanatomy including thickness, cystoid structures, subretinal fluid and retinal traction. Despite these benefits, new technologies can still benefit patients including increasing the resolution, imaging speed, and contrast of OCT technologies. Since 2013, Dr. Tao's group has worked to develop and translate new ophthalmic imaging technologies.

The goal of this proposal is to develop novel OCT technology for improved diagnostic sensitivity in ophthalmology. Specifically, the investigators 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. The aim of this project is to performance 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.

Study Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Novel Ophthalmic Diagnostics using Optical Coherence Tomography
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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