NCT07580040

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

April 17, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

Cigarette SmokingCorneal TomographyBiometryPentacamAnterior SegmentCorneal Densitometry

Outcome Measures

Primary Outcomes (1)

  • Change in Pentacam-measured corneal pachymetry at the pupil center after acute cigarette smoking exposure

    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 Outcomes (1)

  • Change in Pentacam-measured corneal densitometry in the anterior 0-2 mm zone after acute cigarette smoking exposure

    Baseline and immediately after a standardized 10-minute outdoor exposure period

Study Arms (2)

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.

Other: Cigarette Smoking Exposure

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.

Other: No Smoking Exposure

Interventions

Participants in the smoking group smoked cigarettes during a standardized 10-minute outdoor period between baseline and post-exposure assessments.

Smokers

Participants in the control group remained in the same outdoor environment for 10 minutes without smoking between baseline and post-exposure assessments.

Non-smokers

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cigarette SmokingCorneal Diseases

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseEye Diseases

Study Officials

  • Semih Çakmak

    Istanbul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 17, 2026

First Posted

May 12, 2026

Study Start

February 15, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations