search
Back to results

Surgery for Primary Congenital Glaucoma in Neonates

Primary Purpose

Primary Congenital Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
viscotrabeculotomy (VT)
visco-circumferential-suture-trabeculotomy (VCST) .
combined VT-Trabeculectomy with MMC (VT-Trab).
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Congenital Glaucoma

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary Congenital Glaucoma in Neonates

Exclusion Criteria:

secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    viscotrabeculotomy (VT)).

    visco-circumferential-suture-trabeculotomy (VCST)

    Combined VT-Trabeculectomy with MMC (VT-Trab).

    Arm Description

    Outcomes

    Primary Outcome Measures

    success rate in lowering intraocular pressure (IOP)
    Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without AGD or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.

    Secondary Outcome Measures

    horizontal corneal diameter
    The change in "white to white" corneal diameters in mm measured by caliber.
    axial length
    The change in axial length in mm measured by ultrasonography.
    cup-disc ratio
    The change in cup -disc ratio as measured by optical coherence tomography.
    refractive error
    The change in refractive error as measured by autorefractometer..

    Full Information

    First Posted
    January 9, 2021
    Last Updated
    January 12, 2021
    Sponsor
    Mansoura University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04709497
    Brief Title
    Surgery for Primary Congenital Glaucoma in Neonates
    Official Title
    Surgery for Primary Congenital Glaucoma in Neonates:Randomized Controlled Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age.
    Detailed Description
    This is a prospective, randomised controlled trial. We plan to recruit 60 infants with primary congenital glaucoma and younger than 1 month of age at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt. Eyes will be randomly assigned to undergo one of 3 surgical interventions: viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab). The primary outcome of this study is compare the success rate in lowering IOP between the 3 surgical options in infants with Primary Congenital Glaucoma (PCG) below 1 month of age. The secondary clinical outcomes will include Intraocular pressure (IOP), horizontal corneal diameter, axial length, cup-disc ratio, refractive error and postoperative complications in these 3 surgical procedures. Data will be analysed. Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without antiglaucoma drugs (AGD) or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Congenital Glaucoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    viscotrabeculotomy (VT)).
    Arm Type
    Active Comparator
    Arm Title
    visco-circumferential-suture-trabeculotomy (VCST)
    Arm Type
    Active Comparator
    Arm Title
    Combined VT-Trabeculectomy with MMC (VT-Trab).
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    viscotrabeculotomy (VT)
    Intervention Description
    viscotrabeculotomy (VT)
    Intervention Type
    Procedure
    Intervention Name(s)
    visco-circumferential-suture-trabeculotomy (VCST) .
    Intervention Description
    visco-circumferential-suture-trabeculotomy (VCST)
    Intervention Type
    Procedure
    Intervention Name(s)
    combined VT-Trabeculectomy with MMC (VT-Trab).
    Intervention Description
    combined VT-Trabeculectomy with MMC (VT-Trab).
    Primary Outcome Measure Information:
    Title
    success rate in lowering intraocular pressure (IOP)
    Description
    Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without AGD or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    horizontal corneal diameter
    Description
    The change in "white to white" corneal diameters in mm measured by caliber.
    Time Frame
    3 years
    Title
    axial length
    Description
    The change in axial length in mm measured by ultrasonography.
    Time Frame
    3 years
    Title
    cup-disc ratio
    Description
    The change in cup -disc ratio as measured by optical coherence tomography.
    Time Frame
    3 years
    Title
    refractive error
    Description
    The change in refractive error as measured by autorefractometer..
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    30 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary Congenital Glaucoma in Neonates Exclusion Criteria: secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr M Mohammed, MD
    Phone
    1004314242
    Ext
    +20
    Email
    dramrabdelkader@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    providing data as supplemental digital content

    Learn more about this trial

    Surgery for Primary Congenital Glaucoma in Neonates

    We'll reach out to this number within 24 hrs