Clinical Trial: Fuchs' Torsional Phaco Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Maastricht University Medical Center

Current Primary Outcome: Change in central corneal thickness/corneal volume [ Time Frame: 1, 7 days and 1 , 3 and 6 months postoperatively ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in BCVA [ Time Frame: 1, 7 days and 1, 3 and 6 months postoperatively ]

Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: October 27, 2008
Date Started: December 2008
Date Completion:
Last Updated: May 19, 2010
Last Verified: May 2010