Fuch's Endothelial Dystrophy Clinical Trial
Official title:
Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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