iOCT-Cornea: Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05210478
Collaborator
(none)
24
1
60
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Optical coherence tomography (OCT)

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 Design

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea
Anticipated Study Start Date :
Jan 1, 2025
Anticipated Primary Completion Date :
Jan 1, 2028
Anticipated Study Completion Date :
Jan 1, 2030

Outcome Measures

Primary Outcome Measures

  1. Novel Ophthalmic Diagnostics using Optical Coherence Tomography [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Nashville Tennessee United States 37235

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Christine Shieh, Primary Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05210478
Other Study ID Numbers:
  • 201432
First Posted:
Jan 27, 2022
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christine Shieh, Primary Investigator, Vanderbilt University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022