Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule
- Conditions
- Endothelial Cell Loss, Corneal
- Interventions
- Procedure: Rhexis protection shield
- Registration Number
- NCT03855293
- Lead Sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Brief Summary
Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly.
The phacoemulsification technique utilizes a high-intensity ultrasound energy for the fragmentation and emulsification of the lens. One of the main complications during phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the nucleus following turbulent flow of irrigating solution, resulting in corneal damage, inflammation of the endothelium and corneal edema.
In this study we want to evaluate the effect of the anterior capsule, gained by capsular rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Cataract
- Age 21 and older
- Written informed consent prior to surgery
- Moderate to severe nuclear or mixed cataract
- Corneal pathologies
- Pregnancy
- Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Rhexis protection shield rhexis protection shield
- Primary Outcome Measures
Name Time Method endothelium cell loss 1 year Comparison of the lost endothelium cells in both groups
- Secondary Outcome Measures
Name Time Method central corneal thickness 1 year Comparison of corneal thickness between both groups