UNITY DX Cornea Study
2026年8月12日 更新者：Alcon Research
UNITY DX Cornea Precision and Agreement Study
The purpose of this study is to validate the clinical measurement performance of an investigational biometer.
Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of corneal and epithelial thickness maps will be evaluated.
研究概览
详细说明
The study population will consist of male and female adult subjects with normal corneas (approximately 30 subjects), keratoconus (approximately 20 subjects), prior corneal laser vision correction (approximately 20 subjects), current and habitual contact lens wear (approximately 20 subjects), and dry eye (approximately 20 subjects).
In this single visit study, measurements will be taken by 3 different operators using their own set of devices (configuration), UNITY DX and ANTERION.
Each subject's participation is expected to last approximately 3 hours with a planned duration of exposure generally not longer than 10 minutes per device.
Only one eye (designated as the study eye) will be enrolled per subject.
研究类型
观察性的
注册 (估计的)
110
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Alcon Call Center
- 电话号码：1-888-451-3937
- 邮箱：alcon.medinfo@alcon.com
学习地点
-
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Utah
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Salt Lake City、Utah、美国、84107
- The Eye Institute of Utah
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Cohorts will be selected from approximately one investigative site located in the United States.
描述
Key Inclusion Criteria:
- Able to understand and sign an Institutional Review Board approved informed consent form.
- Willing and able to attend all scheduled study visits as required per protocol.
- Identified by the investigator as having normal corneas or abnormal corneas per protocol-specified criteria.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Unable to fixate due to nystagmus or other eye movement abnormality, such as significant strabismus.
- Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
- Active ocular infection or inflammation.
- Other protocol-specified exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Normal Corneas
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with normal corneas.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
|
Keratoconus
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with keratoconus.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
|
Prior Corneal Laser Vision Correction
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with prior corneal laser vision correction.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
|
Current and Habitual Contact Lens Wear
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with current and habitual contact lens wear.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
|
Dry Eye
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with dry eye.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean corneal thickness
大体时间：Day 1
|
Corneal thickness will be measured by the device and reported in microns.
This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
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Day 1
|
|
Mean epithelial thickness
大体时间：Day 1
|
Epithelial thickness will be measured by the device and reported in microns.
This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
|
Day 1
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Clinical Trial Lead, Surgical、Alcon Research, LLC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年8月12日
首先提交符合 QC 标准的
2026年8月12日
首次发布 (实际的)
2026年8月17日
研究记录更新
最后更新发布 (实际的)
2026年8月17日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.