NCT07261176

Effect of Smoking on Retinal Vessel Morphology and Functionality

Effect of Smoking on Retinal Vessel Morphology and Functionality: A Case-Control, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: Italy