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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2019-08-08

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ozurdex group

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.

Group Type EXPERIMENTAL

Dexamethasone implant OZURDEX

Intervention Type DRUG

Interventions

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Dexamethasone implant OZURDEX

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No