Fuchs' Endothelial Dystrophy Clinical Trial
Official title:
Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation
The primary objective is to compare the effect of torsional phacoemulsification and longitudinal phacoemulsification on central and peripheral corneal thickness/volume after cataract surgery in patients with Fuchs' endothelial dystrophy.
Fuchs' endothelial dystrophy is a progressive, bilateral disease of the corneal endothelium,
which eventually leads to corneal decompensation. In the early stage, some patients develop
visually significant cataract. During cataract surgery ultrasound (US) power is used to
emulsify the lens, which leads to endothelial cell loss and tissue damage. The reduction of
US power has become the primary surgical goal in cataract surgery, which is especially
important in patients with Fuchs' endothelial dystrophy to limit endothelial cell loss.
In 2006, Alcon Surgical introduced a torsional mode in its phacoemulsification system
(Infiniti Vision System). It includes a handpiece that produces rotary oscillations of the
phacoemulsification tip and is suggested to reduce the amount of US power required to remove
the cataractous nucleus, because it does not produce repulsion and breaks up the cataract by
shearing and not by the conventional jackhammer effect. This reduction in US power, could
lead to less endothelial cell damage than the conventional (longitudinal) mode, which is
reported recently for patients with hard cataract. It is important to investigate patients
with Fuchs' endothelial dystrophy, because patients with a compromised endothelial cell
layer will benefit the most from less endothelial cell damage. Consequently, this lower
level of endothelial damage may postpone the date of keratoplasty.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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