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Fuchs' Torsional Phaco Study

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ClinicalTrials.gov Identifier: NCT00781027
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : May 20, 2010
Sponsor:
Information provided by:
Maastricht University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fuchs' Endothelial Dystrophy Phacoemulsification Procedure: Phacoemulsification Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation
Study Start Date : December 2008
Actual Primary Completion Date : May 2010

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Arms and Interventions
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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


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

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

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781027


Locations
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Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Study Director: Rudy MMA Nuijts, MD, PhD Maastricht University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. R.M.M.A. Nuijts, Department of Ophthalmology, University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT00781027    
Other Study ID Numbers: MEC 08-2-081
NL24769.068.08
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: May 20, 2010
Last Verified: May 2010
Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
 Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn