Effect of Smoking on Retinal Vessel Morphology and Functionality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-12-01

Brief Summary

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The study aims at evaluating the effect of smoking activity on anatomy and functionality of retinal blood vessels using optical coherence tomography angiography (OCT-A) and dynamic vessel analysis (DVA).

This is a low-risk, single-center, case-control, interventional clinical trial. Forty healthy subjects were enrolled: 20 healthy volunteers with regular daily tobacco activity (approximately 10 cigarettes per day for 5-10 years) and 20 healthy volunteers with no tobacco activity as controls.

Each subject underwent comprehensive ophthalmologic examination including OCT-A, DVA, and retinal vessel analysis (RVA) at baseline. Examinations were repeated for the smoking group at 3 and 30 minutes after smoking activity, and for controls at 8 and 35 minutes after baseline to assess examination variability.

The primary outcomes assessed changes in retinal perfusion and retinal vascular response after cigarette smoking compared to controls.

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Detailed Description

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Conditions

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Smokers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Case-control design with two parallel groups: smokers receiving intervention (smoking one cigarette) and non-smoking controls undergoing examinations at matched time intervals.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Smokers Group

Twenty healthy volunteers with regular daily tobacco activity (approximately 10 cigarettes per day, smoking duration 5-10 years, using cigarettes with 0.8 grams nicotine content). Participants underwent OCT-A, DVA, and RVA examinations at baseline, 3 minutes, and 30 minutes after smoking one cigarette.

Group Type EXPERIMENTAL

Cigarette Smoking

Intervention Type BEHAVIORAL

Participants smoked one cigarette containing 0.8 grams of nicotine under standardized conditions. Participants were required to abstain from tobacco activity for 24 hours prior to baseline examination and to avoid vasoconstrictor substances (coffee, alcohol) before examinations.

Non-smokers Control Group

Twenty healthy volunteers with no tobacco activity as normal life habit. Control participants underwent the same OCT-A, DVA, and RVA examinations at baseline, 8 minutes, and 35 minutes (corresponding timepoints without smoking) to assess examination variability and learning effects.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cigarette Smoking

Participants smoked one cigarette containing 0.8 grams of nicotine under standardized conditions. Participants were required to abstain from tobacco activity for 24 hours prior to baseline examination and to avoid vasoconstrictor substances (coffee, alcohol) before examinations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults of both sexes (age 20 to 30 years old)
* Healthy volunteers who can understand and sign informed consent
* For Smokers Group: Regular daily tobacco activity (approximately 10 cigarettes per day, smoking duration 5-10 years, using cigarettes with 0.8 grams nicotine content)
* For Control Group: No tobacco activity as normal life habit
* Willing to abstain from tobacco activity for 24 hours prior to baseline examination
* Willing to avoid vasoconstrictor substances (coffee, alcohol) prior to examinations

Exclusion Criteria

* Inability to follow planned procedures
* Opacity of dioptric media (lens, cornea, or vitreous) that prevents execution of examinations
* Known allergies that do not allow pupillary dilation
* Ocular pathologies
* Systemic hypertension
* Diabetes mellitus
* Myopia greater than -8.0 Diopters (D)
* Hyperopia greater than +5.0 D
* Astigmatism greater than -3.0 D

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes