NCT03462355

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
Last Updated

March 12, 2018

Status Verified

February 1, 2018

Enrollment Period

3.6 years

First QC Date

March 6, 2018

Last Update Submit

March 6, 2018

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Percentage of smokers

    Percentage of smokers among Cross-linked Keratoconus patients

    After 2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients suffering from Keratoconus and needing Cross-linking therapy

You may qualify if:

  • patients suffering from Keratoconus and needing Cross-linking therapy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 12, 2018

Study Start

March 1, 2014

Primary Completion

September 30, 2017

Study Completion

January 30, 2018

Last Updated

March 12, 2018

Record last verified: 2018-02