Genealogy and quality of life in patient with keratoconus
| ISRCTN | ISRCTN84373661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84373661 |
| Protocol serial number | 2014-A01964-43 |
| Sponsors | Sorbonne Paris Cité, Hospital Hotel-Dieu |
| Funders | Université Sorbonne Paris Cité (France), Assistance Publique-Hopitaux de Paris (France), Association Ophtalmologie Cochin (AOC) |
- 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
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
Scientific
Hotel-Dieu Hospital
Department of Ophthalmology
1, Place du Parvis Notre-Dame
Paris
75004
France
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cross-sectional cohort study prospective non controlled single-centre |
| Secondary study design | Cross sectional study |
| 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(s) |
VF25 QoL score |
| Key secondary outcome measure(s) |
1. Presence or absence of keratoconus in relatives |
| Completion date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 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
1 place du parvis Notre-Dame
Paris
75004
France
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| 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.
