Comparison of Two Techniques in Achieving Corneal Graft

Study Overview
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Brief Summary
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The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front of the eye. When the eye becomes opaque, the eye is not seeing and the only way to restore the visual acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In half the cases the opacification of the cornea is secondary to dysfunction of the endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of regulating the moisture of the corneal thickness and therefore its transparency. While the total corneal transplantation has long been the only intervention for these diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called endothelial transplant or graft lamellar later. This intervention is now experiencing significant success as it reduces very significantly the incidence of complications found after transplantation of total cornea and the visual recovery period. This type of transplant is still difficult to achieve and the best technique is not yet established. Indeed, posterior lamellar transplantation of the cornea may be done manually or using an automated device. Manual techniques allow the preparation of grafts extremely thin but are difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may be less efficient in visual recovery. The aim of this project is to conduct a prospective study in order to compare these two techniques in terms of postoperative visual recovery and the vitality of the graft during the first year. To date, there is no such study. The department of Ophthalmology in the University Hospital of Rouen is one of the most famous French teams in the field of cornea transplants and receives many patients from different French regions. The recruitment of 40 patients needed to study should be done without great difficulty over a period of 18 months.

Official Title
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Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea

Conditions
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Fuch's Endothelial Dystrophy

Intervention / Treatment
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* Procedure: Endothelial descemet membrane graft
* Procedure: Endothelial descemet membrane graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and woman 18 years old or more Patient having been informed about the study and having signed a non-opposition to the participation Exclusion Criteria: Patient presenting an associated eye pathology previously known and able to limit the visual recovery (age-related macular degeneration, diabetic retinopathy, ...) Pregnant women, parturient or breast feeding refusal to participate in the study

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual preparation<br>Manual preparation of the graft | Procedure: Endothelial descemet membrane graft<br>* Standard Endothelial descemet membrane graft<br>|
| Active Comparator: Automatized preparation<br>Automatized preparation of the graft with microkeratoma | Procedure: Endothelial descemet membrane graft<br>* Standard Endothelial descemet membrane graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of visual acuity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occular hypertension | Measurement of occular hypertension | Day 7, Day 15, Month 1, Month 2, Month 6, 1 year | 
| Measurement of visual acuity |  | Month 1, Month 2, Month 6 | 
| Partial or complete graft detachment | % of detachment | Day 7, Day 15, Month 1, Month 2, Month 6, 1 year | 
| Necessity of air injection | Necessity of air injection : yes/no | Day 7, Day 15, Month 1, Month 2, Month 6, 1 year | 
| Defeat of the graft | Defeat of the graft : yes/no | Day 7, Day 15, Month 1, Month 2, Month 6, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fuch's dystrophy, Corneal graft