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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02280-57 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Kali Care | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly transplanted corneal patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use of the KaliJAR box | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio between the number of instilled drops / number of prescribed drops | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| patient behaviour towards corticosteroid treatment | Compliance curve for each patient (pattern / compliance pattern). Compliance profiles versus prescribed treatment at fixed interval time | 12 months |
| Questionnaire on therapeutic compliance |
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Inclusion Criteria:
Exclusion Criteria:
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Newly transplanted corneal patients and adult
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| Name | Affiliation | Role |
|---|---|---|
| Philippe GAIN, MD PhD | CHU de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint Etienne | Saint-Etienne | 42055 | France |
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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.
| month 1, month 6 and month 12 |