Acute Ocular Effects of Cigarette Smoking
2026年5月5日 更新者：Semih Çakmak、Istanbul University
Acute Effects of Cigarette Smoking on Corneal Tomographic and Biometric Parameters: A Prospective Controlled Study
This prospective study aims to evaluate the short-term effects of smoking on corneal tomographic and biometric measurements in healthy adults.
After baseline examinations and measurements are taken in both smoking and non-smoking participants, the same measurements will be repeated after 10 minutes of external exposure, and within-group and between-group changes will be compared.
The aim of the study is to determine whether acute smoking exposure leads to measurable immediate changes in corneal tomographic and biometric parameters.
研究概览
详细说明
This study is a single-center, prospective, and controlled study designed to evaluate the short-term effects of smoking on corneal tomographic and biometric measurements in healthy adults.
The study aimed to include 46 smokers and 46 non-smokers.
To avoid inter-eye correlation, only the right eye of each participant was evaluated.
All participants initially underwent a full ophthalmological examination and measurements were taken using a Pentacam device.
Afterward, all participants waited in standard outdoor conditions for 10 minutes.
During this time, participants in the smoking group smoked, while participants in the control group did not smoke.
The same measurements were repeated at the end of the period.
The study aimed to compare within-group and between-group differences in changes.
研究类型
观察性的
注册 (估计的)
90
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：Semih Çakmak
- 电话号码：902124142000
- 邮箱：semihcakmak@istanbul.edu.tr
学习地点
-
-
-
Istanbul、土耳其（türkiye）、34093
- 招聘中
- Istanbul University, Istanbul Faculty of Medicine
-
接触：
- Semih Çakmak
- 电话号码：905375555141
- 邮箱：semihcakmak@istanbul.edu.tr
-
-
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
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Healthy adult smokers and non-smokers aged 18 to 60 years are planned to be included in this single-center study.
描述
Inclusion Criteria:
- Healthy adults aged 18 to 60 years
- Current smokers in the smoking group
- Never-smokers in the control group
- Willing and able to undergo ophthalmic examination and Pentacam AXL measurements
Exclusion Criteria:
- History of ocular surgery or ocular trauma
- Presence of corneal disease, retinal disease, or ocular surface disorder
- Clinically significant dry eye disease
- Contact lens use within the last 2 weeks
- Use of medications that may affect the ocular surface or pupillary dynamics, including anticholinergics or sympathomimetics
- Systemic diseases such as diabetes mellitus or hypertension
- Former smoking history in the control group
- Use of electronic cigarettes or other tobacco products
- Inability to cooperate adequately for accurate measurement
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 |
|---|---|
|
Smokers
Healthy adult participants with active cigarette smoking exposure who underwent baseline ophthalmic examination and Pentacam measurements, followed by repeat measurements after a standardized 10-minute outdoor period during which they smoked.
|
Participants in the smoking group smoked cigarettes during a standardized 10-minute outdoor period between baseline and post-exposure assessments.
|
|
Non-smokers
Healthy adult participants without cigarette smoking exposure who underwent baseline ophthalmic examination and Pentacam measurements, followed by repeat measurements after a standardized 10-minute outdoor period under the same environmental conditions without smoking.
|
Participants in the control group remained in the same outdoor environment for 10 minutes without smoking between baseline and post-exposure assessments.
|
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 |
|---|---|---|
|
Change in Pentacam-measured corneal pachymetry at the pupil center after acute cigarette smoking exposure
大体时间：Baseline and immediately after a standardized 10-minute outdoor exposure period
|
Change (post-exposure minus baseline) in corneal pachymetry at the pupil center, measured in micrometers (µm) using Pentacam.
The magnitude of change will be compared between smokers and non-smokers.
|
Baseline and immediately after a standardized 10-minute outdoor exposure period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Pentacam-measured corneal densitometry in the anterior 0-2 mm zone after acute cigarette smoking exposure
大体时间：Baseline and immediately after a standardized 10-minute outdoor exposure period
|
Change (post-exposure minus baseline) in corneal densitometry in the anterior 0-2 mm zone, measured in grayscale units (GSU) using Pentacam.
The magnitude of change will be compared between smokers and non-smokers.
|
Baseline and immediately after a standardized 10-minute outdoor exposure period
|
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
- 首席研究员：Semih Çakmak、Istanbul University
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 (实际的)
2026年2月15日
初级完成 (估计的)
2026年5月1日
研究完成 (估计的)
2026年5月1日
研究注册日期
首次提交
2026年4月17日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- IstanbulU-2026-3901546
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared because the study was not designed with a data-sharing plan and the dataset contains participant-level information.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.