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Effect of Smoking on Retinal Vessel Morphology and Functionality

NCT07261176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-03

No results posted yet for this study

Summary

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.

Conditions

  • Smokers

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Francesco Bandello, MD · Ospedale San Raffaele

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07261176 on ClinicalTrials.gov