Fuchs' Torsional Phaco Study

May 19, 2010 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • University Hospital Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Torsional phacoemulsification
Procedure: Phacoemulsification
Comparison of longitudinal phacoemulsification and torsional phacoemulsification
Active Comparator: 2
Longitudinal phacoemulsification
Procedure: Phacoemulsification
Comparison of longitudinal phacoemulsification and torsional phacoemulsification

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in BCVA
Time Frame: 1, 7 days and 1, 3 and 6 months postoperatively
1, 7 days and 1, 3 and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Study Director: Rudy MMA Nuijts, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (Estimate)

October 28, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2010

Last Update Submitted That Met QC Criteria

May 19, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 08-2-081
  • NL24769.068.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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