Intraoperative Optical Coherence Tomography - Normals
- Conditions
- Healthy Volunteers
- Registration Number
- NCT04790890
- Lead Sponsor
- Vanderbilt University Medical Center
- 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.
- 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, 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. 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- Healthy adults (>18 years) with no pre-existing ophthalmic conditions
- Children or adults unable to consent
- Any volunteers with history of ocular disease/injury
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanderbilt University
🇺🇸Nashville, Tennessee, United States