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NCT03462355 Clinical Trial

Tobacco Smoking Among Crosslinked-keratoconus Patients

Keratoconus Clinical Trial

— TOBACOLINK  

Official title:
Tobacco Smoking Among Crosslinked-keratoconus Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03462355
Other study ID # 2017-02Obs-CHRMT
Secondary ID
Status Completed
Phase N/A
First received March 6, 2018
Last updated March 6, 2018
Start date March 1, 2014
Est. completion date January 30, 2018

Study information
Verified date February 2018
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The aim of this study was to assess a possible link between keratoconus (KC) occurrence and patients' smoking habits.

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).

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date January 30, 2018
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients suffering from Keratoconus and needing Cross-linking therapy

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of smokers Percentage of smokers among Cross-linked Keratoconus patients After 2 years
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