Fuchs' Torsional Phaco Study
Primary Purpose
Fuchs' Endothelial Dystrophy, Phacoemulsification
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Fuchs' Endothelial Dystrophy
Eligibility 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
Sites / Locations
- University Hospital Maastricht
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Torsional phacoemulsification
Longitudinal phacoemulsification
Outcomes
Primary Outcome Measures
Change in central corneal thickness/corneal volume
Secondary Outcome Measures
Changes in BCVA
Full Information
NCT ID
NCT00781027
First Posted
October 27, 2008
Last Updated
May 19, 2010
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00781027
Brief Title
Fuchs' Torsional Phaco Study
Official Title
Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy, Phacoemulsification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Torsional phacoemulsification
Arm Title
2
Arm Type
Active Comparator
Arm Description
Longitudinal phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification
Intervention Description
Comparison of longitudinal phacoemulsification and torsional phacoemulsification
Primary Outcome Measure Information:
Title
Change in central corneal thickness/corneal volume
Time Frame
1, 7 days and 1 , 3 and 6 months postoperatively
Secondary Outcome Measure Information:
Title
Changes in BCVA
Time Frame
1, 7 days and 1, 3 and 6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudy MMA Nuijts, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
24030086
Citation
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.
Results Reference
derived
Learn more about this trial
Fuchs' Torsional Phaco Study
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