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The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties

Primary Purpose

Glaucoma Eye

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ex-Press mini shunt insertion
Trabeculectomy
Sponsored by
Democritus University of Thrace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma Eye focused on measuring glaucoma, trabeculectomy, Ex-PRESS glaucoma drainage implant, corneal hysteresis, corneal resistance factor

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18
  • Average Intraocular pressure > 24 mmHg on at least 2 occasions 1 month before surgery
  • Congenital glaucoma

Exclusion Criteria:

  • Previous ocular trauma
  • Previous ocular surgery other than phacoemulsification
  • Previous disease of the ocular surface

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Patients undergoing Ex-Press mini shunt insertion

    Patients undergoing trabeculectomy

    Arm Description

    Patients in this arm had the Ex-Press mini shunt inserted in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer

    Patients in this arm had standard trabeculectomy in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer

    Outcomes

    Primary Outcome Measures

    Change of corneal biomechanical properties
    Two corneal biomechanical properties were measured with the use of the Ocular Response Analyzer (ORA): the Corneal Resistance Factor (CRF) and the Corneal Hysteresis (CH). These two indicators were measured before surgery and at 1, 6 and 12 months after surgery

    Secondary Outcome Measures

    Change of Intraocular Pressure
    The Intraocular Pressure was measured with the Goldmann applanation tonometer before surgery and at 1, 6 and 12 months after surgery

    Full Information

    First Posted
    November 21, 2020
    Last Updated
    November 24, 2020
    Sponsor
    Democritus University of Thrace
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04648943
    Brief Title
    The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties
    Official Title
    The Effect of Antiglaucoma Procedures (Trabeculectomy vs. Ex-PRESS Glaucoma Drainage Implant) on the Corneal Biomechanical Properties
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2013 (Actual)
    Primary Completion Date
    May 31, 2016 (Actual)
    Study Completion Date
    November 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Democritus University of Thrace

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma
    Detailed Description
    The patients in the study were divided into two groups. In group 1 the patients had the Ex-PRESS mini shunt inserted in the operated eye and in group 2 the patients underwent standard trabeculectomy. The corneal biomechanical properties were measured with the Ocular Response Analyzer before surgery and at 1, 6 and 12 months after surgery. The corneal biomechanical properties measured were the Corneal Hysteresis (CH) and the Corneal Resistance Factor (CRF). The change of the CH and CRF was compared in each group before and after surgery (at the aforementioned predetermined time points) and between the two groups. The intraocular pressure was also measured with the Goldmann applanation tonometer at the same time points and the change was compared before and after surgery in each group and between the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma Eye
    Keywords
    glaucoma, trabeculectomy, Ex-PRESS glaucoma drainage implant, corneal hysteresis, corneal resistance factor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients undergoing Ex-Press mini shunt insertion
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm had the Ex-Press mini shunt inserted in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer
    Arm Title
    Patients undergoing trabeculectomy
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm had standard trabeculectomy in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer
    Intervention Type
    Procedure
    Intervention Name(s)
    Ex-Press mini shunt insertion
    Intervention Type
    Procedure
    Intervention Name(s)
    Trabeculectomy
    Primary Outcome Measure Information:
    Title
    Change of corneal biomechanical properties
    Description
    Two corneal biomechanical properties were measured with the use of the Ocular Response Analyzer (ORA): the Corneal Resistance Factor (CRF) and the Corneal Hysteresis (CH). These two indicators were measured before surgery and at 1, 6 and 12 months after surgery
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change of Intraocular Pressure
    Description
    The Intraocular Pressure was measured with the Goldmann applanation tonometer before surgery and at 1, 6 and 12 months after surgery
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 Average Intraocular pressure > 24 mmHg on at least 2 occasions 1 month before surgery Congenital glaucoma Exclusion Criteria: Previous ocular trauma Previous ocular surgery other than phacoemulsification Previous disease of the ocular surface
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Georgios Labiris, MD, PhD
    Organizational Affiliation
    Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties

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