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

NCT04107246 | Completed

• 2 other identifiers: 19CH1452019-A02280-57
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Graft Disorder (Disorder); Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Ratio between the number of instilled drops / number of prescribed drops

  12 months

Secondary Outcomes (2)

• patient behaviour towards corticosteroid treatment

  12 months

• Questionnaire on therapeutic compliance

  month 1, month 6 and month 12

Study Arms (1)

Newly transplanted corneal patients

Device: use of the KaliJAR box

Interventions

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.

Newly transplanted corneal patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly transplanted corneal patients and adult

You may qualify if:

• 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

You may not qualify if:

• Patients under guardianship
• Patients unable to give their consent or to correctly use the collection box

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Kali Care: collaborator

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Study Officials

• Philippe GAIN, MD PhD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: November 20, 2019
• Primary Completion: October 7, 2020
• Study Completion: October 22, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)