NCT03855293|Completed
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Sponsor study identifier
interventional
70
0 countries
N/A
Study Start
March 2, 2016
Actual (reported)Primary Completion
April 1, 2017
Actual (reported)Study Completion
April 5, 2018
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 5, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2016
Actual (reported)April 1, 2017
Actual (reported)April 5, 2018
Actual (reported)February 24, 2019
Actual (reported)February 26, 2019
Actual (reported)endothelium cell loss
Comparison of the lost endothelium cells in both groups
1 year
central corneal thickness
1 year
rhexis protection shield
regular surgery
In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation
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70 participants (actual enrollment reported by the registry).
First Submitted
February 24, 2019
First Posted
February 26, 2019
Study Start
March 2, 2016
Actual (reported)Endothelial Changes in Pseudoexfoliation Syndrome
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Primary Completion
April 1, 2017
Actual (reported)Study Completion
April 5, 2018
Actual (reported)Last Updated
February 26, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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