Clinical Trial: Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone: Tolerance and Safety Pilot Study

Brief Summary:

Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and constitute one of the main factors reducing graft survival. They mainly occur during the first 18 months. Prevention usually relies on a topical treatment with dexamethasone or prednisolone for standard risk patients. Eye drops are instilled three times a day during at least 3 months then tapered.

OZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone during several months. It is indicated for intravitreal injection to treat macular edema.

The investigators hypothesized that this implant could be used after subconjunctival injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop instillations.


Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Current Primary Outcome: intraocular pressure [ Time Frame: one month post graft ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Score of ocular discomfort [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
    analogic visual scale
  • Ocular redness [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
    digital picture
  • Rejection episodes [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
  • Graft thickness [ Time Frame: one month post graft ]
  • Patient requiring dexamethasone eyedrops [ Time Frame: one month post graft ]
  • Date of disappearance of the implant [ Time Frame: up to 1 year ]
  • intraocular pressure [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
  • presence of hemorrhage [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12 ]
    with tomography


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Saint Etienne

Dates:
Date Received: July 8, 2016
Date Started: January 2017
Date Completion: May 2018
Last Updated: January 19, 2017
Last Verified: January 2017