Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule
NCT ID: NCT03855293
Last Updated: 2019-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2016-03-02
2018-04-05
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study group
rhexis protection shield
Rhexis protection shield
In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation
Control group
regular surgery
No interventions assigned to this group
Interventions
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Rhexis protection shield
In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation
Eligibility Criteria
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Inclusion Criteria
* Age 21 and older
* Written informed consent prior to surgery
* Moderate to severe nuclear or mixed cataract
Exclusion Criteria
* Pregnancy
* Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)
21 Years
ALL
No
Sponsors
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Prim. Prof. Dr. Oliver Findl, MBA
OTHER
Responsible Party
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Prim. Prof. Dr. Oliver Findl, MBA
Prim. Prof. Dr.
Other Identifiers
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Rhexis Protection Shield
Identifier Type: -
Identifier Source: org_study_id
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