Effect of Smoking on Retinal Vessel Morphology and Functionality

San Donato Group (GSD)

Status: Completed

Conditions: Smokers

Treatments: Behavioral: Cigarette Smoking

Study type: Interventional

Funder types: Other

Identifiers

NCT07261176

SMOKE-DVA

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Smokers Group

Experimental group

Description:

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.

Treatment:

Behavioral: Cigarette Smoking

Non-smokers Control Group

No Intervention group

Description:

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.