Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Children or adults unable to consent

Healthy adults (>18 years) without diagnosis of cornea transplant (keratoplasty)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: