- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07580040
Acute Ocular Effects of Cigarette Smoking
May 5, 2026 updated by: 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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Semih Çakmak
- Phone Number: 902124142000
- Email: semihcakmak@istanbul.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34093
- Recruiting
- Istanbul University, Istanbul Faculty of Medicine
-
Contact:
- Semih Çakmak
- Phone Number: 905375555141
- Email: semihcakmak@istanbul.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy adult smokers and non-smokers aged 18 to 60 years are planned to be included in this single-center study.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pentacam-measured corneal pachymetry at the pupil center after acute cigarette smoking exposure
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pentacam-measured corneal densitometry in the anterior 0-2 mm zone after acute cigarette smoking exposure
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Semih Çakmak, Istanbul University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2026
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
April 17, 2026
First Submitted That Met QC Criteria
May 5, 2026
First Posted (Actual)
May 12, 2026
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 5, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulU-2026-3901546
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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