A Phase 4 interventional study of Phacoemulsification in Fuchs' Endothelial Dystrophy and Phacoemulsification, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2010-05-20.
Sponsored by Maastricht University Medical Center · Phase 4, Interventional, and Treatment
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.
90 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 28 are open to participants now.
This study's planned enrollment of 50 is close to the median of 54 across 63 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Torsional phacoemulsification
Procedure: Phacoemulsification
Longitudinal phacoemulsification
Procedure: Phacoemulsification
Comparison of longitudinal phacoemulsification and torsional phacoemulsification
Change in central corneal thickness/corneal volume
Time frame: 1, 7 days and 1 , 3 and 6 months postoperatively
Changes in BCVA
Time frame: 1, 7 days and 1, 3 and 6 months postoperatively
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center