Fuchs' Torsional Phaco Study

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781027
• Other study ID #: MEC 08-2-081
• Secondary ID: NL24769.068.08
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2008
• Last updated: May 19, 2010
• Start date: December 2008

Study information

• Verified date: May 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 95 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy
• Phacoemulsification

Intervention

Procedure:
• Phacoemulsification
Comparison of longitudinal phacoemulsification and torsional phacoemulsification

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in central corneal thickness/corneal volume		1, 7 days and 1 , 3 and 6 months postoperatively	Yes
Secondary	Changes in BCVA		1, 7 days and 1, 3 and 6 months postoperatively	No