Eye ManifestationsNCT04776863
Effect of Smokeless Tobacco on Anterior Segment
An observational study of Eye Manifestations and Tobacco; Use, Harmful, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Observational, comparative, cross-sectional study Read more about this study
- Who is it for?
- Ages 26 to 49 years
- Conditions the study is for
- Eye Manifestations, Tobacco; Use, Harmful, Tobacco Chewing Toxicity
- What is being tested?
- optical biometry measurement
- Type of treatment
- Medical device
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Nov 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 26 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: All the study subjects underwent a full ophthalmological examination.The anterior segment parameter measurements were taken with optical biometry. Each subject was questioned in respect of how many years and how many times a day they used ST. Before taking the optical biometry measurements, the subjects were questioned as to whether they had used ST, drunk anything containing caffeine or smoked cigarettes in the previous 12 hours, and those who had were excluded from the study. Each subject was given 1mg ST and the optical biometry measurements were repeated after 5, 30 and 60 mins. A single measurement was performed with optical biometry in the control group. To avoid diurnal variations, the measurements were taken in the morning between 09.00 and 12.00 hours.
Who may be able to join
- A subject who use ST
- A subject who was not using ST
Who cannot join
- Refractive disorder
- Systemic chronic disease (diabetes, hypertension, neurological, etc.)
- Ocular trauma
- Ocular surgery
- Glaucoma
- Optic disc abnormalities
- Congenital anomaly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abdullah Beyoğlu
Kahramanmaraş, None Selected, 46040
About this study
Official title: Evaluation of the Effect of Smokeless Tobacco on Anterior Segment Parameters
Observational, comparative, cross-sectional study
Read the detailed description
To evaluate the acute and chronic effects of smokeless tobacco (ST) on the anterior segment parameters using optical biometry. Observational, comparative, cross-sectional study Place and Duration of Study: Department of Ophthalmology, Kahramanmaras Sutcu Imam University.
The study included 53 right eyes of 53 subjects (study group), who used ST and 54 right eyes of 54 healthy subjects without ST (control group). Following a full ophthalmological examination, baseline measurements were taken with optical biometry and these measurements were repeated at 5, 30 and 60 mins after using ST.
- Being tested
- optical biometry measurement
- Keywords
- Optical biometry, pupillar diameter, smokeless tobacco
- Medical subject headings
- Eye Manifestations, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical biometry measurementDevice
The measurements of the individuals using smokeless tobacco and those who do not were taken by optical biometry.
| Study group | Role | What they receive |
|---|---|---|
| Smokeless tobacco | Individuals using smokeless tobacco Receives: Device: optical biometry measurement | |
| No smokeless tobacco | Individuals who do not use smokeless tobacco Receives: Device: optical biometry measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Corneal Thickness (CCT)
Change in Central Corneal Thickness (CCT
Measured: Baseline to 60 minutes after intervention
Axial Length (AL)
Change in Axial Length (AL)
Measured: Baseline to 60 minutes after intervention
Anterior chamber deep (ACD)
Change in Anterior chamber deep (ACD)
Measured: Baseline to 60 minutes after intervention
Lens thickness (LT)
Change in Lens thickness (LT)
Measured: Baseline to 60 minutes after intervention
Pupillary diameter (PD)
Change in Pupillary diameter (PD)
Measured: Baseline to 60 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Mar 2020
- Primary completion31 Jul 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye ManifestationsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Beyoğlu, Kahramanmaras Sutcu Imam University
- Investigators
- Abdullah Beyoğlu, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776863
- Sponsor's protocol ID
- decision no: 285 dated:24-2018
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Smokeless Tobacco on Anterior Segment Parameters
- ClinicalTrials.gov ID
- NCT04776863
- Acronym / sponsor ID
- decision no: 285 dated:24-2018
- Keywords
- Optical biometry, pupillar diameter, smokeless tobacco
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 2 Mar 2021 (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.
Observational, comparative, cross-sectional study
Detailed description
To evaluate the acute and chronic effects of smokeless tobacco (ST) on the anterior segment parameters using optical biometry. Observational, comparative, cross-sectional study Place and Duration of Study: Department of Ophthalmology, Kahramanmaras Sutcu Imam University.
The study included 53 right eyes of 53 subjects (study group), who used ST and 54 right eyes of 54 healthy subjects without ST (control group). Following a full ophthalmological examination, baseline measurements were taken with optical biometry and these measurements were repeated at 5, 30 and 60 mins after using ST.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokeless tobacco | – | Device: optical biometry measurementIndividuals using smokeless tobacco |
| No smokeless tobacco | – | Device: optical biometry measurementIndividuals who do not use smokeless tobacco |
Who may qualify
- Ages
- 26 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All the study subjects underwent a full ophthalmological examination.The anterior segment parameter measurements were taken with optical biometry. Each subject was questioned in respect of how many years and how many times a day they used ST. Before taking the optical biometry measurements, the subjects were questioned as to whether they had used ST, drunk anything containing caffeine or smoked cigarettes in the previous 12 hours, and those who had were excluded from the study. Each subject was given 1mg ST and the optical biometry measurements were repeated after 5, 30 and 60 mins. A single measurement was performed with optical biometry in the control group. To avoid diurnal variations, the measurements were taken in the morning between 09.00 and 12.00 hours.
Key inclusion criteria (2 listed)
- A subject who use ST
- A subject who was not using ST
Key exclusion criteria (7 listed)
- Refractive disorder
- Systemic chronic disease (diabetes, hypertension, neurological, etc.)
- Ocular trauma
- Ocular surgery
- Glaucoma
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 |
|---|---|---|
| optical biometry measurementThe measurements of the individuals using smokeless tobacco and those who do not were taken by optical biometry. | Device | No smokeless tobacco, Smokeless tobacco |
Primary outcome
Central Corneal Thickness (CCT)
Time frame: Baseline to 60 minutes after intervention
Change in Central Corneal Thickness (CCT
Axial Length (AL)
Time frame: Baseline to 60 minutes after intervention
Change in Axial Length (AL)
Anterior chamber deep (ACD)
Time frame: Baseline to 60 minutes after intervention
Change in Anterior chamber deep (ACD)
Lens thickness (LT)
Time frame: Baseline to 60 minutes after intervention
Change in Lens thickness (LT)
Pupillary diameter (PD)
Time frame: Baseline to 60 minutes after intervention
Change in Pupillary diameter (PD)
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 2 Mar 2021.
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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.
Abdullah Beyoğlu study chair
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Manifestations and Tobacco; Use, Harmful, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 2 Mar 2021. 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 Turkey (Türkiye). 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 Corneal Thickness (CCT) (time frame: Baseline to 60 minutes after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.