Fuchs' Torsional Phaco Study
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Fuchs' Endothelial Dystrophy Phacoemulsification |
Procedure: Phacoemulsification |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation |
- Change in central corneal thickness/corneal volume [ Time Frame: 1, 7 days and 1 , 3 and 6 months postoperatively ] [ Designated as safety issue: Yes ]
- Changes in BCVA [ Time Frame: 1, 7 days and 1, 3 and 6 months postoperatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2008 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Netherlands | |
| University Hospital Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| Study Director: | Rudy MMA Nuijts, MD, PhD | Maastricht University Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. R.M.M.A. Nuijts, Department of Ophthalmology, University Hospital Maastricht |
| ClinicalTrials.gov Identifier: | NCT00781027 History of Changes |
| Other Study ID Numbers: | MEC 08-2-081, NL24769.068.08 |
| Study First Received: | October 27, 2008 |
| Last Updated: | May 19, 2010 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Fuchs' Endothelial Dystrophy Corneal Dystrophies, Hereditary Corneal Diseases |
Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 23, 2013