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Completed

NCT Number: NCT00781027

Fuchs' Torsional Phaco Study

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.

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Key information

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phacoemulsification

Procedure

Comparison of longitudinal phacoemulsification and torsional phacoemulsification

Primary outcomes

  1. Change in central corneal thickness/corneal volume

    Time frame: 1, 7 days and 1 , 3 and 6 months postoperatively

Secondary outcomes

  1. Changes in BCVA

    Time frame: 1, 7 days and 1, 3 and 6 months postoperatively

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
First posted
Oct 28, 2008
Registry last updated
May 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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