Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea

Corneal Transplantation Clinical Trial

— iOCT-Cornea  

Official title:

Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05210478
• Other study ID #: 201432
• Status: Not yet recruiting
• Start date: January 2025
• Est. completion date: January 2030

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Marybeth Carter, BS
• Phone: 615-936-1639
• Email: marybeth.l.carter[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 2030
• Est. primary completion date: January 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Corneal Diseases
• Corneal Transplantation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

LIA

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.