Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Maastricht University Medical Center |
---|---|
Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00781027 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation |
Estimated Enrollment: | 50 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Torsional phacoemulsification
|
Procedure: Phacoemulsification
Comparison of longitudinal phacoemulsification and torsional phacoemulsification
|
2: Active Comparator
Longitudinal phacoemulsification
|
Procedure: Phacoemulsification
Comparison of longitudinal phacoemulsification and torsional phacoemulsification
|
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.
Ages Eligible for Study: | 40 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Muriel Doors, MD | 0031433877686 | muriel.doors@mumc.nl |
Netherlands | |
University Hospital Maastricht | Recruiting |
Maastricht, Netherlands, 6202 AZ |
Study Director: | Rudy MMA Nuijts, MD, PhD | Maastricht University Medical Center |
Responsible Party: | Department of Ophthalmology, University Hospital Maastricht ( Dr. R.M.M.A. Nuijts ) |
Study ID Numbers: | MEC 08-2-081, NL24769.068.08 |
Study First Received: | October 27, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00781027 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Corneal Diseases Corneal Dystrophy Fuchs' Endothelial 1 Genetic Diseases, Inborn Corneal Dystrophy Corneal Dystrophies, Hereditary |
Eye Diseases Cataract Fuchs' Endothelial Dystrophy Eye Diseases, Hereditary |
Corneal Diseases Genetic Diseases, Inborn Corneal Dystrophies, Hereditary |
Eye Diseases Fuchs' Endothelial Dystrophy Eye Diseases, Hereditary |