Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule

Endothelial Cell Loss, Corneal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855293
• Other study ID #: Rhexis Protection Shield
• Status: Completed
• Phase: N/A
• Start date: March 2, 2016
• Est. completion date: April 5, 2018

Study information

• Verified date: February 2019
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 5, 2018
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Cell Loss
• Endothelial Cell Loss, Corneal

Intervention

Procedure:
• Rhexis protection shield
In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelium cell loss	Comparison of the lost endothelium cells in both groups	1 year
Secondary	central corneal thickness	Comparison of corneal thickness between both groups	1 year