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OpenTrials
Completed

NCT Number: NCT03855293

Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule

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.

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Key information

Conditions

Endothelial Cell Loss, Corneal Corneal Diseases Corneal Endothelial Cell Loss Eye Diseases Eye Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rhexis protection shield

Procedure

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

Primary outcomes

  1. endothelium cell loss

    Time frame: 1 year

    Comparison of the lost endothelium cells in both groups

Secondary outcomes

  1. central corneal thickness

    Time frame: 1 year

    Comparison of corneal thickness between both groups

Sponsors and collaborators

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 26, 2019
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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