SmokersNCT07261176
Effect of Smoking on Retinal Vessel Morphology and Functionality
A study testing Cigarette Smoking in people with Smokers, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Smokers
- What is being tested?
- Cigarette Smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Myopia greater than -8.0 Diopters (D)
- Hyperopia greater than +5.0 D
- Astigmatism greater than -3.0 D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Smoking on Retinal Vessel Morphology and Functionality: A Case-Control, Clinical Trial
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.
Read more
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
- Being tested
- Cigarette Smoking
- Keywords
- smoke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette SmokingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smokers Group | Experimental | 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. Receives: Behavioral: Cigarette Smoking |
| Non-smokers Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Retinal Artery Equivalent (CRAE)
Changes in central retinal artery equivalent measured using Retinal Vessel Analyzer (RVA). CRAE relates to the diameter of the central retinal artery, expressed in measurement units (MU). Higher values indicate larger arterial diameter.
Measured: Baseline, 3 minutes and 30 minutes post-smoking (smokers); baseline, 8 minutes and 35 minutes (controls)
Arterial Dilation Percentage Post-Flicker Stimulation
Percentage increase in retinal arterial vessel diameter in response to flicker light stimulation measured by Dynamic Vessel Analyzer (DVA). Calculated as percentage increase in vessel diameter relative to baseline after 20 seconds of flicker stimulation, averaged across 3 measurement cycles.
Measured: Baseline, 3 minutes and 30 minutes post-smoking (smokers); baseline, 8 minutes and 35 minutes (controls)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Apr 2021
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case-control design with two parallel groups: smokers receiving intervention (smoking one cigarette) and non-smoking controls undergoing examinations at matched time intervals.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Querques Giuseppe, IRCCS San Raffaele
- Investigators
- Francesco Bandello, MD, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261176
- Sponsor's protocol ID
- SMOKE-DVA
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu X, Yang K, Xiao Y, Ye C, Zheng J, Su B, Zheng Y, Zhang X, Shi K, Li C, Lu F, Qu J, Li M, Cui L. Association of cigarette smoking with retinal capillary plexus: an optical coherence tomography angiography study. Acta Ophthalmol. 2022 Nov;100(7):e1479-e1488. doi: 10.1111/aos.15157. Epub 2022 Apr 9.
PubMed 35396902Garhofer G, Resch H, Sacu S, Weigert G, Schmidl D, Lasta M, Schmetterer L. Effect of regular smoking on flicker induced retinal vasodilatation in healthy subjects. Microvasc Res. 2011 Nov;82(3):351-5. doi: 10.1016/j.mvr.2011.07.001. Epub 2011 Jul 12.
PubMed 21771603Ciesielski M, Rakowicz P, Stopa M. Immediate effects of smoking on optic nerve and macular perfusion measured by optical coherence tomography angiography. Sci Rep. 2019 Jul 15;9(1):10161. doi: 10.1038/s41598-019-46746-z.
PubMed 31308472Siedlecki J, Mohr N, Luft N, Schworm B, Keidel L, Priglinger SG. Effects of Flavanol-Rich Dark Chocolate on Visual Function and Retinal Perfusion Measured With Optical Coherence Tomography Angiography: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Dec 1;137(12):1373-1379. doi: 10.1001/jamaophthalmol.2019.3731.
PubMed 31556937McClintic SM, Jia Y, Huang D, Bailey ST. Optical coherence tomographic angiography of choroidal neovascularization associated with central serous chorioretinopathy. JAMA Ophthalmol. 2015 Oct;133(10):1212-4. doi: 10.1001/jamaophthalmol.2015.2126. No abstract available.
PubMed 26135638Huang Y, Zhang Q, Thorell MR, An L, Durbin MK, Laron M, Sharma U, Gregori G, Rosenfeld PJ, Wang RK. Swept-source OCT angiography of the retinal vasculature using intensity differentiation-based optical microangiography algorithms. Ophthalmic Surg Lasers Imaging Retina. 2014 Sep-Oct;45(5):382-9. doi: 10.3928/23258160-20140909-08.
PubMed 25230403de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015 Apr 15;1:5. doi: 10.1186/s40942-015-0005-8. eCollection 2015.
PubMed 27847598
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking on Retinal Vessel Morphology and Functionality: A Case-Control, Clinical Trial
- ClinicalTrials.gov ID
- NCT07261176
- Acronym / sponsor ID
- SMOKE-DVA
- Conditions
- Smokers
- Keywords
- smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-control design with two parallel groups: smokers receiving intervention (smoking one cigarette) and non-smoking controls undergoing examinations at matched time intervals.
| Arm | Type | Receives |
|---|---|---|
| Smokers Group | Experimental | Behavioral: Cigarette SmokingTwenty 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. |
| Non-smokers Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cigarette SmokingParticipants 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. | Behavioural | Smokers Group |
Primary outcome
Central Retinal Artery Equivalent (CRAE)
Time frame: Baseline, 3 minutes and 30 minutes post-smoking (smokers); baseline, 8 minutes and 35 minutes (controls)
Changes in central retinal artery equivalent measured using Retinal Vessel Analyzer (RVA). CRAE relates to the diameter of the central retinal artery, expressed in measurement units (MU). Higher values indicate larger arterial diameter.
Arterial Dilation Percentage Post-Flicker Stimulation
Time frame: Baseline, 3 minutes and 30 minutes post-smoking (smokers); baseline, 8 minutes and 35 minutes (controls)
Percentage increase in retinal arterial vessel diameter in response to flicker light stimulation measured by Dynamic Vessel Analyzer (DVA). Calculated as percentage increase in vessel diameter relative to baseline after 20 seconds of flicker stimulation, averaged across 3 measurement cycles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 35396902Zhu X, Yang K, Xiao Y, Ye C, Zheng J, Su B, Zheng Y, Zhang X, Shi K, Li C, Lu F, Qu J, Li M, Cui L. Association of cigarette smoking with retinal capillary plexus: an optical coherence tomography angiography study. Acta Ophthalmol. 2022 Nov;100(7):e1479-e1488. doi: 10.1111/aos.15157. Epub 2022 Apr 9.
- Background: PubMed 21771603Garhofer G, Resch H, Sacu S, Weigert G, Schmidl D, Lasta M, Schmetterer L. Effect of regular smoking on flicker induced retinal vasodilatation in healthy subjects. Microvasc Res. 2011 Nov;82(3):351-5. doi: 10.1016/j.mvr.2011.07.001. Epub 2011 Jul 12.
- Background: PubMed 31308472Ciesielski M, Rakowicz P, Stopa M. Immediate effects of smoking on optic nerve and macular perfusion measured by optical coherence tomography angiography. Sci Rep. 2019 Jul 15;9(1):10161. doi: 10.1038/s41598-019-46746-z.
- Background: PubMed 31556937Siedlecki J, Mohr N, Luft N, Schworm B, Keidel L, Priglinger SG. Effects of Flavanol-Rich Dark Chocolate on Visual Function and Retinal Perfusion Measured With Optical Coherence Tomography Angiography: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Dec 1;137(12):1373-1379. doi: 10.1001/jamaophthalmol.2019.3731.
- Background: PubMed 26135638McClintic SM, Jia Y, Huang D, Bailey ST. Optical coherence tomographic angiography of choroidal neovascularization associated with central serous chorioretinopathy. JAMA Ophthalmol. 2015 Oct;133(10):1212-4. doi: 10.1001/jamaophthalmol.2015.2126. No abstract available.
- Background: PubMed 25230403Huang Y, Zhang Q, Thorell MR, An L, Durbin MK, Laron M, Sharma U, Gregori G, Rosenfeld PJ, Wang RK. Swept-source OCT angiography of the retinal vasculature using intensity differentiation-based optical microangiography algorithms. Ophthalmic Surg Lasers Imaging Retina. 2014 Sep-Oct;45(5):382-9. doi: 10.3928/23258160-20140909-08.
- Background: PubMed 27847598de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015 Apr 15;1:5. doi: 10.1186/s40942-015-0005-8. eCollection 2015.
- IRCCS Ospedale San Raffaele Official WebsiteLink provided by the sponsor.
- Vita-Salute San Raffaele UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Bandello, MD principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarette Smoking in people with Smokers, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Retinal Artery Equivalent (CRAE) (time frame: Baseline, 3 minutes and 30 minutes post-smoking (smokers); baseline, 8 minutes and 35 minutes (controls)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07261176, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.