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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

October 27, 2008
October 28, 2008
May 20, 2010
December 2008
May 2010   (Final data collection date for primary outcome measure)
Change in central corneal thickness/corneal volume [ Time Frame: 1, 7 days and 1 , 3 and 6 months postoperatively ]
Same as current
Complete list of historical versions of study NCT00781027 on ClinicalTrials.gov Archive Site
Changes in BCVA [ Time Frame: 1, 7 days and 1, 3 and 6 months postoperatively ]
Same as current
Not Provided
Not Provided
 
Fuchs' Torsional Phaco Study
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fuchs' Endothelial Dystrophy
  • Phacoemulsification
Procedure: Phacoemulsification
Comparison of longitudinal phacoemulsification and torsional phacoemulsification
  • Active Comparator: 1
    Torsional phacoemulsification
    Intervention: Procedure: Phacoemulsification
  • Active Comparator: 2
    Longitudinal phacoemulsification
    Intervention: Procedure: Phacoemulsification
Doors M, Berendschot TT, Touwslager W, Webers CA, Nuijts RM. Phacopower modulation and the risk for postoperative corneal decompensation: a randomized clinical trial. JAMA Ophthalmol. 2013 Nov;131(11):1443-50. doi: 10.1001/jamaophthalmol.2013.5009.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
Not Provided
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 95 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00781027
MEC 08-2-081
NL24769.068.08
No
Not Provided
Not Provided
Dr. R.M.M.A. Nuijts, Department of Ophthalmology, University Hospital Maastricht
Maastricht University Medical Center
Not Provided
Study Director: Rudy MMA Nuijts, MD, PhD Maastricht University Medical Center
Maastricht University Medical Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP