Genealogy and quality of life in patient with keratoconus

ISRCTN	ISRCTN84373661
DOI	https://doi.org/10.1186/ISRCTN84373661
Secondary identifying numbers	2014-A01964-43

Submission date: 24/12/2014
Registration date: 11/02/2015
Last edited: 14/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Jean-Louis Bourges
Scientific

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

Study information

Study design	Cross-sectional cohort study prospective non controlled single-centre
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Quality of life
Scientific title	Genealogy and quality of life in patient with keratoconus: a cross-sectional cohort study
Study acronym	KCQoL
Study objectives	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(s)	Société Francaise d'Ophtalmologie (SFO)
Health condition(s) or problem(s) studied	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
Primary outcome measure	VF25 QoL score
Secondary outcome measures	1. Presence or absence of keratoconus in relatives 2. Age of parents
Overall study start date	01/01/2015
Completion date	01/06/2015

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	200
Total final enrolment	101
Key inclusion criteria	Patient with keratoconus based upon criteria from corneal topography and their relatives
Key exclusion criteria	Patients with keratoplasty
Date of first enrolment	01/01/2015
Date of final enrolment	01/06/2015

Locations

Countries of recruitment

France

Study participating centre

Hotel-Dieu, Paris

Department of Ophthalmology
1 place du parvis Notre-Dame
Paris
75004
France

Sponsor information

Sorbonne Paris Cité
University/education

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

Website	http://www.sorbonne-paris-cite.fr/en
"ROR"	https://ror.org/001z21q04

Hospital Hotel-Dieu
Hospital/treatment centre

Department of Ophthalmology
1, Place du Parvis Notre-Dame
Paris
75004
France

Phone	+33142348234
Email	cs-oph.rdv@htd.aphp.fr
Website	http://www.aphp.fr/hopital/hotel-dieu/

Funders

Funder type

University/education

Université Sorbonne Paris Cité (France)

No information available

Assistance Publique-Hopitaux de Paris (France)

No information available

Association Ophtalmologie Cochin (AOC)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2020	14/08/2020	Yes	No

Editorial Notes

14/08/2020: Publication reference and total final enrolment number added.