Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule
Primary Purpose
Endothelial Cell Loss, Corneal
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhexis protection shield
Sponsored by
About this trial
This is an interventional treatment trial for Endothelial Cell Loss, Corneal
Eligibility Criteria
Inclusion Criteria:
- Cataract
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Study group
Control group
Arm Description
rhexis protection shield
regular surgery
Outcomes
Primary Outcome Measures
endothelium cell loss
Comparison of the lost endothelium cells in both groups
Secondary Outcome Measures
central corneal thickness
Comparison of corneal thickness between both groups
Full Information
NCT ID
NCT03855293
First Posted
February 24, 2019
Last Updated
February 24, 2019
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT03855293
Brief Title
Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule
Official Title
Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Cell Loss, Corneal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Other
Arm Description
rhexis protection shield
Arm Title
Control group
Arm Type
No Intervention
Arm Description
regular surgery
Intervention Type
Procedure
Intervention Name(s)
Rhexis protection shield
Intervention Description
In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation
Primary Outcome Measure Information:
Title
endothelium cell loss
Description
Comparison of the lost endothelium cells in both groups
Time Frame
1 year
Secondary Outcome Measure Information:
Title
central corneal thickness
Description
Comparison of corneal thickness between both groups
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cataract
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)
12. IPD Sharing Statement
Learn more about this trial
Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule
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