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Punch Trabeculectomy Versus Classic Trabeculectomy

Primary Purpose

Glaucoma, Open-Angle

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
releasable sutures in punch trabeculectomy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of primary open-angle glaucoma
  • Clinical diagnosis of pigmentary glaucoma
  • Clinical diagnosis of Pseudophakic glaucoma

Exclusion Criteria:

  • high risk factors for failed trabeculectomy must be present e.g. previous failed trabeculectomy surgery and active intraocular infection/ inflammation.
  • Clinical diagnosis of aphakic glaucoma was excluded.
  • Clinical diagnosis of glaucoma with previous ocular incisional surgery (except for clear cornea cataract surgery) were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    tight flap technique group (forty patients-group A)

    loose flap technique (securing sutures) group (forty patients-group B).

    Arm Description

    in this arm forty patients did tight flap technique for punch trabeculectomy. At 12 o'clock 10/0 nylon monofilament stitch was used to close the apex of triangular scleral flap tightly and two releasable stitches were used at the sides of triangular scleral flap.

    in this arm forty patients did loose flap technique for punch trabeculectomy. At 12 o'clock 10/0 nylon monofilament stitch was used to secure the edges of the flap at the apex of and two-four releasable stitches were used at the sides of triangular scleral flap in group B.

    Outcomes

    Primary Outcome Measures

    postoperative intraocular pressure (IOP)
    measuring IOP at first day ,first month, three months, six months, nine months,and one year after surgery frequent interval in both groups with applanation method( Goldmann applanation tonometer

    Secondary Outcome Measures

    bleb morphology after surgery
    examination of bleb formed after surgery with Silt Lamp.we comment on the bleb features on each patient in study groups as grade-1 (high elevated bleb), grade-2 (low elevated bleb), grade-3-(encysted bleb), grade-4 (flat bleb).

    Full Information

    First Posted
    November 23, 2020
    Last Updated
    November 26, 2020
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04651231
    Brief Title
    Punch Trabeculectomy Versus Classic Trabeculectomy
    Official Title
    Values of Releasable Sutures in Punch Trabeculectomy Prospective Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 20, 2012 (Actual)
    Primary Completion Date
    June 28, 2014 (Actual)
    Study Completion Date
    October 16, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    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
    Bleb failure is reduced with Punch trabeculectomy procedure. Wide sclerostomy during surgery is wanted but controllable. This can be done with single securing suture, releasable sutures and topical intraoperative mitomycin-c. Average IOP without fluctuation (risk factor) can protect the optic nerve.
    Detailed Description
    This is a prospective randomized study. Patients had uncontrolled glaucoma on maximum tolerated medical therapy including acetazolamide tablets were enrolled in this clinical trial and were randomized to tight flap technique group (group A) and loose flap technique group(group B). Randomization assigned 40 patients to group A and 40 patients to do group B. A total of 80 patients were enrolled in the Study between 2012 and 2014. During trabeculectomy, Trabecular meshwork and scleral lamellae were excised made an opening with the kelly scleral punch 1.0 mm 3-5 bites. At 12 o'clock 10/0 nylon monofilament stitch was used to close the apex of triangular scleral flap tightly and two releasable stitches were used at the sides of triangular scleral flap in group A. Fig-1 At 12 o'clock 10/0 nylon monofilament stitch was used to secure the edges of the flap at the apex of and two-four releasable stitches were used at the sides of triangular scleral flap in group B. The intraocular pressure and bleb morphology were followed for one year after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Open-Angle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Eighty Patients inclusive, randomly distributed for tight flap technique group (forty patients-group A) and for loose flap technique (securing sutures) group (forty patients-group B).
    Masking
    Participant
    Masking Description
    The participants were masked during study time through permuted variable block randomization scheme.
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tight flap technique group (forty patients-group A)
    Arm Type
    Active Comparator
    Arm Description
    in this arm forty patients did tight flap technique for punch trabeculectomy. At 12 o'clock 10/0 nylon monofilament stitch was used to close the apex of triangular scleral flap tightly and two releasable stitches were used at the sides of triangular scleral flap.
    Arm Title
    loose flap technique (securing sutures) group (forty patients-group B).
    Arm Type
    Experimental
    Arm Description
    in this arm forty patients did loose flap technique for punch trabeculectomy. At 12 o'clock 10/0 nylon monofilament stitch was used to secure the edges of the flap at the apex of and two-four releasable stitches were used at the sides of triangular scleral flap in group B.
    Intervention Type
    Procedure
    Intervention Name(s)
    releasable sutures in punch trabeculectomy
    Other Intervention Name(s)
    loose flap technique versus tight flap technique in punch trabeculectomy
    Intervention Description
    punch trabeculectomy,scleral flap suturing
    Primary Outcome Measure Information:
    Title
    postoperative intraocular pressure (IOP)
    Description
    measuring IOP at first day ,first month, three months, six months, nine months,and one year after surgery frequent interval in both groups with applanation method( Goldmann applanation tonometer
    Time Frame
    one-year follow up
    Secondary Outcome Measure Information:
    Title
    bleb morphology after surgery
    Description
    examination of bleb formed after surgery with Silt Lamp.we comment on the bleb features on each patient in study groups as grade-1 (high elevated bleb), grade-2 (low elevated bleb), grade-3-(encysted bleb), grade-4 (flat bleb).
    Time Frame
    one-year follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of primary open-angle glaucoma Clinical diagnosis of pigmentary glaucoma Clinical diagnosis of Pseudophakic glaucoma Exclusion Criteria: high risk factors for failed trabeculectomy must be present e.g. previous failed trabeculectomy surgery and active intraocular infection/ inflammation. Clinical diagnosis of aphakic glaucoma was excluded. Clinical diagnosis of glaucoma with previous ocular incisional surgery (except for clear cornea cataract surgery) were excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Given the data in determining evidence-based medicine and evidence-based public health policies, sharing this type of data is seen as particularly important.

    Learn more about this trial

    Punch Trabeculectomy Versus Classic Trabeculectomy

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