Plain English Summary
Background and study aims
Keratoconus is an eye condition in which the cornea (the clear dome-shaped “window” of the eye) becomes weaker, thinner and changes shape over time. It is usually diagnosed in teenagers and young adults. What causes the condition is not known, but it is thought possible that its passed down through the family (genetic inheritance) and it’s more common in people with allergic diseases (for example, asthma). Many cases can be managed by wearing contact lenses or glasses, but very advanced cases may only be treatable with a corneal transplant (keratoplasty). We want to investigate both the possible inheritance pattern of the disease and the quality of life for patients for which keratoconus is being managed without surgery.
Who can participate?
Any patient with a keratoconus condition and their relatives.
What does the study involve?
Participants take part in an opthalmologic (eye) examination and a corneal topography (a computer-assisted non-invasive technique that creates a topological map of the cornea). They are also asked to fill in a questionnaire about their quality of life.
What are the possible benefits and risks of participating?
Potential benefits to participation in this study include identifying keratoconus in relatives of the patient, resulting in earlier and more successful treatment. There is no risk to participating.
Where is the study run from?
Hotel-Dieu Hospital, Department of ophthalmology, Paris (France)
When is the study starting and how long is it expected to run for?
January 2015 to June 2015
Who is funding the study?
1. University Sorbonne Paris Cité (France)
2. Assistance Publique-Hopitaux de Paris (France)
Who is the main contact?
Professor Jean-Louis Bourges
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2014-A01964-43
Study information
Scientific title
Genealogy and quality of life in patient with keratoconus: a cross-sectional cohort study
Acronym
KCQoL
Study hypothesis
Corneal imaging and therapeutic strategies are continuously improving. Keratoconus can now be detected earlier now than a decade ago. The evolution can now be tackled whereas the cost effectiveness of treatments should be rationalized as much as possible. Thus, the prevalence and the real quality of life of the keratoconus patients should both be evaluated again.
Ethics approval
Société Francaise d'Ophtalmologie (SFO)
Study design
Cross-sectional cohort study prospective non controlled single-centre
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Keratoconus
Intervention
We plan to submit patients to the VF25 questionnaire for Quality of Life and find out of any relatives also have the disease.
Intervention type
Other
Phase
Drug names
Primary outcome measure
VF25 QoL score
Secondary outcome measures
1. Presence or absence of keratoconus in relatives
2. Age of parents
Overall trial start date
01/01/2015
Overall trial end date
01/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patient with keratoconus based upon criteria from corneal topography and their relatives
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
200
Total final enrolment
101
Participant exclusion criteria
Patients with keratoplasty
Recruitment start date
01/01/2015
Recruitment end date
01/06/2015
Locations
Countries of recruitment
France
Trial participating centre
Hotel-Dieu, Paris
Department of Ophthalmology
1 place du parvis Notre-Dame
Paris
75004
France
Sponsor information
Organisation
Sorbonne Paris Cité
Sponsor details
Faculty of Medicine
Paris Descartes
Assistance Publique-Hopitaux de Paris
Paris
-
France
Sponsor type
University/education
Website
http://www.sorbonne-paris-cite.fr/en
Organisation
Hospital Hotel-Dieu
Sponsor details
Department of Ophthalmology
1
Place du Parvis Notre-Dame
Paris
75004
France
+33142348234
cs-oph.rdv@htd.aphp.fr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Université Sorbonne Paris Cité (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Assistance Publique-Hopitaux de Paris (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Association Ophtalmologie Cochin (AOC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Other
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32296993/ (added 14/08/2020)