Corneal Graft Disorder (Disorder), Corticosteroid
Conditions
Brief summary
Following corneal graft, local steroids with a gradually decreasing dose for 12 months are prescribed to reduce the graft rejection risk (maximum incidence of 20% for the first 12 months). The validated KaliJAR® device is a box for single-dose eye drops collection. This innovative tool will make it possible to objectify the compliance of patients with a corneal graft. Unlike the field of glaucoma, no specific compliance data are available for corneal grafts, although it is important because graft rejection is the most important cause of corneal graft failure.
Interventions
DEVICEuse of the KaliJAR box
KaliJAR® : validated device for single-dose eye drops collection. the patient will be asked to discard each single dose of eye drops in the KaliJAR box. The patient returns with the KaliJAR box at each consultation as part of normal practice. The KaliJAR box will be emptied at each consultation by the doctor and then returned to the patient. No further examination or visit.
Sponsors
Kali Care
Centre Hospitalier Universitaire de Saint Etienne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly transplanted corneal patients * Patients able to instill correctly topical corticosteroid treatment * Patients able to come to control visits * Patient affiliated or entitled to a social security system * Patient informed about the study and having signed a consent
Exclusion criteria
* Patients under guardianship * Patients unable to give their consent or to correctly use the collection box
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio between the number of instilled drops / number of prescribed drops | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient behaviour towards corticosteroid treatment | 12 months | Compliance curve for each patient (pattern / compliance pattern). Compliance profiles versus prescribed treatment at fixed interval time |
| Questionnaire on therapeutic compliance | month 1, month 6 and month 12 | Morisky questionnaire : Adherence to treatment is good if the score is greater than or equal to 8. Adherence to treatment is average if the score is 6 or 7. Adherence to treatment is low if the score is less than 6. |
Countries
France
Outcome results
None listed