Fuchs' Torsional Phaco Study

Phase 4

Completed

• Conditions: Fuchs' Endothelial Dystrophy; Phacoemulsification
• Interventions: Procedure: Phacoemulsification

• Registration Number: NCT00781027
• Lead Sponsor: Maastricht University Medical Center

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 Description

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.

Study Timeline

• Study First Submitted: 2008-10-27
• Study First Submitted QC: 2008-10-27
• Study First Posted: 2008-10-28
• Study Start: 2008-12
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Last Update Submitted: 2010-05-19
• Last Update Posted: 2010-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients diagnosed with Fuchs' endothelial dystrophy (all stages) and planning to undergo cataract surgery due to visually significant cataract
• Patients should be 40 years of age or older

Exclusion Criteria

• Patients with Fuchs' dystrophy with a history of previous corneal or intraocular surgery
• Patients with a planned combined surgical procedure
• Patients who have other vision-affecting disorders than Fuchs' endothelial dystrophy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Phacoemulsification	Torsional phacoemulsification
2	Phacoemulsification	Longitudinal phacoemulsification

Primary Outcome Measures

Name	Time	Method
Change in central corneal thickness/corneal volume	1, 7 days and 1 , 3 and 6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Changes in BCVA	1, 7 days and 1, 3 and 6 months postoperatively

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands