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临床试验/NCT04790890
NCT04790890Enrolling By Invitation不适用

Intraoperative Optical Coherence Tomography - Normals

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
1
主要终点
Novel Ophthalmic Diagnostics using Optical Coherence Tomography

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Children or adults unable to consent
  • Any volunteers with history of ocular disease/injury

结局指标

主要结局

Novel Ophthalmic Diagnostics using Optical Coherence Tomography

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuankai Tao

Primary Investigator

Vanderbilt University Medical Center

研究点 (1)

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