Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule

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

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.

Study Overview

• Status: Completed
• Conditions: Endothelial Cell Loss, Corneal
• Intervention / Treatment: Procedure: Rhexis protection shield

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study group; rhexis protection shield	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
No Intervention: Control group; regular surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endothelium cell loss	Comparison of the lost endothelium cells in both groups	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
central corneal thickness	Comparison of corneal thickness between both groups	1 year

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 5, 2018

Study Registration Dates

• First Submitted: February 24, 2019
• First Submitted That Met QC Criteria: February 24, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Postoperative Complications; Lens Diseases; Corneal Diseases; Eye Manifestations; Cataract; Corneal Endothelial Cell Loss
• Other Study ID Numbers: Rhexis Protection Shield

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No