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OpenTrials
Completed

NCT Number: NCT04107246

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

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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Key information

Conditions

Corneal Graft Disorder (Disorder) Corticosteroid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Ratio between the number of instilled drops / number of prescribed drops

    Time frame: 12 months

Secondary outcomes

  1. patient behaviour towards corticosteroid treatment

    Time frame: 12 months

    Compliance curve for each patient (pattern / compliance pattern). Compliance profiles versus prescribed treatment at fixed interval time

  2. Questionnaire on therapeutic compliance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Kali Care

Registry information

Acronym: KALICORT

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 27, 2019
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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