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Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule

Primary Purpose

Endothelial Cell Loss, Corneal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhexis protection shield
Sponsored by
Prim. Prof. Dr. Oliver Findl, MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endothelial Cell Loss, Corneal

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Study group

    Control group

    Arm Description

    rhexis protection shield

    regular surgery

    Outcomes

    Primary Outcome Measures

    endothelium cell loss
    Comparison of the lost endothelium cells in both groups

    Secondary Outcome Measures

    central corneal thickness
    Comparison of corneal thickness between both groups

    Full Information

    First Posted
    February 24, 2019
    Last Updated
    February 24, 2019
    Sponsor
    Prim. Prof. Dr. Oliver Findl, MBA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03855293
    Brief Title
    Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule
    Official Title
    Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2, 2016 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    April 5, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Prim. Prof. Dr. Oliver Findl, MBA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endothelial Cell Loss, Corneal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Other
    Arm Description
    rhexis protection shield
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    regular surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Rhexis protection shield
    Intervention Description
    In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation
    Primary Outcome Measure Information:
    Title
    endothelium cell loss
    Description
    Comparison of the lost endothelium cells in both groups
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    central corneal thickness
    Description
    Comparison of corneal thickness between both groups
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

    Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule

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