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Идёт набор NCT07580040

Acute Ocular Effects of Cigarette Smoking

— Наблюдательное Smoking ( Cigarette) Cornea Anterior Eye Segment Measurements

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cigarette Smoking Exposure, No Smoking Exposure.
Кому может быть актуально
Состояния в реестре: Smoking ( Cigarette), Cornea, Anterior Eye Segment Measurements. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Acute Effects of Cigarette Smoking on Corneal Tomographic and Biometric Parameters: A Prospective Controlled Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Cigarette Smoking Exposure
    Participants in the smoking group smoked cigarettes during a standardized 10-minute outdoor period between baseline and post-exposure assessments.
  • Другое No Smoking Exposure
    Participants in the control group remained in the same outdoor environment for 10 minutes without smoking between baseline and post-exposure assessments.

Первичные конечные точки

  • Change in Pentacam-measured corneal pachymetry at the pupil center after acute cigarette smoking exposure [Срок оценки: Baseline and immediately after a standardized 10-minute outdoor exposure period]
Вторичные конечные точки (1)
  • Change in Pentacam-measured corneal densitometry in the anterior 0-2 mm zone after acute cigarette smoking exposure [Срок оценки: Baseline and immediately after a standardized 10-minute outdoor exposure period]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul University, Istanbul Faculty of Medicine — Istanbul

Идентификаторы

NCT: NCT07580040 · IstanbulU-2026-3901546

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗