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

Centre Hospitalier Universitaire de Saint Etienne14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Keratoconus Fuchs' Endothelial Dystrophy Congenital Hereditary Stromal Dystrophy of the Cornea

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Keratoconus * Fuch's dystrophy * Hereditary stromal dystrophy * Age 18 years old and more * Signed informed consent * Affiliated to the French Social Security Exclusion Criteria: * Hypersensitivity to Dexamethasone or the excipients (polylactic and glycolic acid) * Active ocular or periocular infection * Advanced glaucoma * History of herpetic or zoster keratitis * Retinal disease for which an intravitreal injection of Ozurdex is planed for the next 3-4 months

Outcomes

Primary Outcomes

intraocular pressure

Time frame: one month post graft

Secondary Outcomes

Score of ocular discomfort

analogic visual scale

Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12

Ocular redness

digital picture

Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12

Rejection episodes

Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, 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, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12

presence of hemorrhage

with tomography

Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes