Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops

Completed

• Conditions: Corticosteroid; Corneal Graft Disorder (Disorder)
• Interventions: Device: use of the KaliJAR box

• Registration Number: NCT04107246
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Study Start: 2019-11-20
• Primary Completion: 2020-10-07
• Study Completion: 2021-10-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newly transplanted corneal patients	use of the KaliJAR box	-

Primary Outcome Measures

Name	Time	Method
Ratio between the number of instilled drops / number of prescribed drops	12 months

Secondary Outcome Measures

Name	Time	Method
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.
patient behaviour towards corticosteroid treatment	12 months	Compliance curve for each patient (pattern / compliance pattern). Compliance profiles versus prescribed treatment at fixed interval time

Trial Locations

Locations (1)

CHU de Saint Etienne; 🇫🇷 Saint Etienne, France