Congenital Hereditary Stromal Dystrophy of the Cornea, Fuchs' Endothelial Dystrophy, Keratoconus
Conditions
Keywords
absorbable implant, subconjunctival, immune rejection, safety profile, dexamethasone
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.
Interventions
DRUGDexamethasone implant OZURDEX
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intraocular pressure | one month post graft |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular redness | 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 | digital picture |
| Rejection episodes | 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 | one month post graft | — |
| Score of ocular discomfort | 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 | analogic visual scale |
| Date of disappearance of the implant | up to 1 year | — |
| intraocular pressure | 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 | 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 | with tomography |
| Patient requiring dexamethasone eyedrops | one month post graft | — |
Countries
France
Outcome results
None listed