Condition category
Eye Diseases
Date applied
24/12/2014
Date assigned
11/02/2015
Last edited
04/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Professor Jean-Louis Bourges

ORCID ID

Contact details

Hotel-Dieu Hospital
Department of Ophthalmology
1
Place du Parvis Notre-Dame
Paris
75004
France

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 measures

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

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

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

Université Sorbonne Paris Cité

Sponsor details

Faculty of Medicine
Paris Descartes
Assistance Publique-Hopitaux de Paris
Paris
-
France

Sponsor type

Hospital/treatment centre

Website

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

http://www.aphp.fr/hopital/hotel-dieu/

Funders

Funder type

Hospital/treatment centre

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes