KeratoconusTOBACOLINKNCT03462355
Tobacco Smoking Among Crosslinked-keratoconus Patients
An observational study of Keratoconus, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
Certain studies reported that cigarette by-products may make the cornea more rigid, suggesting that it could lead to "natural" CXL of collagen fibers, hence a protective effect for KC. Others have reported that cigarette smoking causes no significant changes in the corneal biomechanics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Keratoconus
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 30 Jan 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients suffering from Keratoconus and needing Cross-linking therapy
Who may be able to join
- patients suffering from Keratoconus and needing Cross-linking therapy
Who cannot join
- none
About this study
Certain studies reported that cigarette by-products may make the cornea more rigid, suggesting that it could lead to "natural" CXL of collagen fibers, hence a protective effect for KC. Others have reported that cigarette smoking causes no significant changes in the corneal biomechanics. The aim of this study was to assess a possible link between keratoconus (KC) occurrence and patients' smoking habits.
Read the detailed description
a telephone Survey was performed among 80 KC patients who were treated from March 2014 until September 2017 by accelerated crosslinking (A-CXL) within the ophthalmology department. From the 80 people we phoned, 62 answered. Our questions were regarding family history, allergic history, and smoking habits. Family history was considered positive if a first-degree or second-degree relative had been diagnosed with KC. Allergies toward any kind of external factors were marked as positive. Patients' smoking habits were recorded and classified into regular, occasional, ex-smoker and non-smoker. The results were confronted to those of the general population by indirect standardization over age and sex according to the "Baromètre Santé 2010" INPES survey (French Nation Institute for Prevention and Health Education).
- Conditions
- Keratoconus
- Medical subject headings
- Keratoconus
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of smokers
Percentage of smokers among Cross-linked Keratoconus patients
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Mar 2014
- Primary completion30 Sep 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462355
- Sponsor's protocol ID
- 2017-02Obs-CHRMT
- Acronym
- TOBACOLINK
- Status last verified
- Feb 2018
- First submitted
- 6 Mar 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Smoking Among Crosslinked-keratoconus Patients
- ClinicalTrials.gov ID
- NCT03462355
- Acronym / sponsor ID
- TOBACOLINK / 2017-02Obs-CHRMT
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 12 Mar 2018 (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.
Certain studies reported that cigarette by-products may make the cornea more rigid, suggesting that it could lead to "natural" CXL of collagen fibers, hence a protective effect for KC. Others have reported that cigarette smoking causes no significant changes in the corneal biomechanics. The aim of this study was to assess a possible link between keratoconus (KC) occurrence and patients' smoking habits.
Detailed description
a telephone Survey was performed among 80 KC patients who were treated from March 2014 until September 2017 by accelerated crosslinking (A-CXL) within the ophthalmology department. From the 80 people we phoned, 62 answered. Our questions were regarding family history, allergic history, and smoking habits. Family history was considered positive if a first-degree or second-degree relative had been diagnosed with KC. Allergies toward any kind of external factors were marked as positive. Patients' smoking habits were recorded and classified into regular, occasional, ex-smoker and non-smoker. The results were confronted to those of the general population by indirect standardization over age and sex according to the "Baromètre Santé 2010" INPES survey (French Nation Institute for Prevention and Health Education).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients suffering from Keratoconus and needing Cross-linking therapy
Key inclusion criteria (1 listed)
- patients suffering from Keratoconus and needing Cross-linking therapy
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of smokers
Time frame: After 2 years
Percentage of smokers among Cross-linked Keratoconus patients
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 12 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Centre Hospitalier Régional Metz-Thionville.
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 1 inclusion and 1 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of smokers (time frame: After 2 years). 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 12 Mar 2018.