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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001168-12 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ozurdex group | Experimental | Subconjunctival injection of the absorbable implant of Dexamethasone immediately at the end of penetrating keratoplasty. The injection is made at the 12 O'Clock position is a bubble created by subconjunctival injection of balanced salt solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone implant OZURDEX | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure | one month post graft |
| Measure | Description | Time Frame |
|---|---|---|
| Score of ocular discomfort | analogic visual scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Caroline TRONE, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint Etienne | Saint-Etienne | 42055 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34426402 | Derived | Trone MC, Poinard S, Crouzet E, Garcin T, Mentek M, Forest F, Matray M, Thuret G, Gain P. Dropless penetrating keratoplasty using a subconjunctival dexamethasone implant: safety pilot study. Br J Ophthalmol. 2023 Feb;107(2):181-186. doi: 10.1136/bjophthalmol-2021-319376. Epub 2021 Aug 23. |
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digital picture
| 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 | 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 |
| Patient requiring dexamethasone eyedrops | one month post graft |
| 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 | with tomography | 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 |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D005642 | Fuchs' Endothelial Dystrophy |
| C566452 | Corneal Dystrophy, Congenital Stromal |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D003317 | Corneal Dystrophies, Hereditary |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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