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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Dexamethasone implant OZURDEX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ozurdex group<br>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. | Drug: Dexamethasone implant OZURDEX<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  | one month post graft | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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absorbable implant, subconjunctival, immune rejection, safety profile, dexamethasone