Skip to main content
Clinical Trials/NCT03855293
NCT03855293
Completed
Not Applicable

Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study

Prim. Prof. Dr. Oliver Findl, MBA0 sites70 target enrollmentMarch 2, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endothelial Cell Loss, Corneal
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Enrollment
70
Primary Endpoint
endothelium cell loss
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2016
End Date
April 5, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible Party
Sponsor Investigator
Principal Investigator

Prim. Prof. Dr. Oliver Findl, MBA

Prim. Prof. Dr.

Vienna Institute for Research in Ocular Surgery

Eligibility Criteria

Inclusion Criteria

  • Age 21 and older
  • Written informed consent prior to surgery
  • Moderate to severe nuclear or mixed cataract

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

endothelium cell loss

Time Frame: 1 year

Comparison of the lost endothelium cells in both groups

Secondary Outcomes

  • central corneal thickness(1 year)

Similar Trials