Intraoperative Optical Coherence Tomography - Normals

NCT ID: NCT04790890

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Optical coherence tomography (OCT)

Optical coherence tomography (OCT) is a non-invasive imaging test which uses light waves to take cross-section pictures of the retina.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy adults (\>18 years) with no pre-existing ophthalmic conditions

Exclusion Criteria

* Children or adults unable to consent
* Any volunteers with history of ocular disease/injury
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yuankai Tao

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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LIA,

Reference Type 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.

Reference Type BACKGROUND
PMID: 25798298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26469616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16424539 (View on PubMed)

Other Identifiers

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202230

Identifier Type: -

Identifier Source: org_study_id

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