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Iris Tissue in Primary Congenital Glaucoma

Primary Purpose

Primary Congenital Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined trabeculotomy-trabeculectomy with mitomycin c
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Congenital Glaucoma

Eligibility Criteria

7 Days - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Typical symptoms of epiphora , photophobia and blepharospasm
  2. corneal diameter > 13 mm
  3. Increased ocular tension > 25 mmHg UGA using schiotz tonometer

Exclusion Criteria:

  1. Infants with history of previous surgery
  2. Secondary glaucoma
  3. Glaucoma associated with other congenital anomalies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental : Infants with primary congenital glaucoma

    Arm Description

    Outcomes

    Primary Outcome Measures

    Present histopathological features of iris tissue in infants with primary congenital glaucoma which may play a role in pathogenesis
    Histopathological features of iris tissue in infants with primary congenital glaucoma who underwent Combined trabeculotomy-trabeculectomy with mitomycin C

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2019
    Last Updated
    October 20, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04079725
    Brief Title
    Iris Tissue in Primary Congenital Glaucoma
    Official Title
    Histopathological Examination of Iris Tissue in Primary Congenital Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    To present the histopathological features of the iris tissue in primary congenital glaucoma which may play a role in pathogenesis
    Detailed Description
    Primary congenital glaucoma etiology still remains obscure . originally barkan , and later Worst , proposed that a membrane covered the anterior chamber angle and blocked aqueous outflow , but the presence of that membrane has not been established histopathologically to date . Now most authors believe that the site of obstruction is the trabecular meshwork rather than an overlying membrane . Maldevelopment of the anterior segment is present in all forms of congenital glaucoma . this maldevelopment may involve the trabecular meshwork alone or the trabecular meshwork in combination with the iris or cornea or both. In approcimately 50% of patients , isolated trabeculodysgensis is the only developmental ocular anomaly found .This is the classic defect found in primary congenital glaucoma .These eyes have no developmental anomalies of iris or cornea present except abnormal insertion of the iris into the angle

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental : Infants with primary congenital glaucoma
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Combined trabeculotomy-trabeculectomy with mitomycin c
    Other Intervention Name(s)
    Histopathological examination of iris tissue
    Intervention Description
    Combined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases then histopathological examination of iris tissue to detect the nature of the disease
    Primary Outcome Measure Information:
    Title
    Present histopathological features of iris tissue in infants with primary congenital glaucoma which may play a role in pathogenesis
    Description
    Histopathological features of iris tissue in infants with primary congenital glaucoma who underwent Combined trabeculotomy-trabeculectomy with mitomycin C
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Days
    Maximum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Typical symptoms of epiphora , photophobia and blepharospasm corneal diameter > 13 mm Increased ocular tension > 25 mmHg UGA using schiotz tonometer Exclusion Criteria: Infants with history of previous surgery Secondary glaucoma Glaucoma associated with other congenital anomalies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Omar Abdelkarem Hasan, M.B.B.Ch.
    Phone
    +201000525341
    Email
    oabdelkarem@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9627644
    Citation
    Mandal AK, Naduvilath TJ, Jayagandan A. Surgical results of combined trabeculotomy-trabeculectomy for developmental glaucoma. Ophthalmology. 1998 Jun;105(6):974-82. doi: 10.1016/S0161-6420(98)96022-5.
    Results Reference
    background
    PubMed Identifier
    19744731
    Citation
    Suri F, Yazdani S, Narooie-Nejhad M, Zargar SJ, Paylakhi SH, Zeinali S, Pakravan M, Elahi E. Variable expressivity and high penetrance of CYP1B1 mutations associated with primary congenital glaucoma. Ophthalmology. 2009 Nov;116(11):2101-9. doi: 10.1016/j.ophtha.2009.04.045. Epub 2009 Sep 10.
    Results Reference
    background
    PubMed Identifier
    16527674
    Citation
    Biglan AW. Glaucoma in children: are we making progress? J AAPOS. 2006 Feb;10(1):7-21. doi: 10.1016/j.jaapos.2005.10.001.
    Results Reference
    background
    PubMed Identifier
    20006816
    Citation
    Black AC, Jones S, Yanovitch TL, Enyedi LB, Stinnett SS, Freedman SF. Latanoprost in pediatric glaucoma--pediatric exposure over a decade. J AAPOS. 2009 Dec;13(6):558-62. doi: 10.1016/j.jaapos.2009.10.003.
    Results Reference
    background
    PubMed Identifier
    16406536
    Citation
    Kargi SH, Koc F, Biglan AW, Davis JS. Visual acuity in children with glaucoma. Ophthalmology. 2006 Feb;113(2):229-38. doi: 10.1016/j.ophtha.2005.10.029. Epub 2006 Jan 10.
    Results Reference
    background
    PubMed Identifier
    14522762
    Citation
    Mandal AK, Gothwal VK, Bagga H, Nutheti R, Mansoori T. Outcome of surgery on infants younger than 1 month with congenital glaucoma. Ophthalmology. 2003 Oct;110(10):1909-15. doi: 10.1016/S0161-6420(03)00671-7.
    Results Reference
    background
    Citation
    Ocular Pathology Atlas. American Academy of Ophthalmology Web site. https://www.aao.org/resident-course/pathology-atlas. Published 2016. Accessed January 4, 2017
    Results Reference
    background
    Citation
    American Academy of Ophthalmology. Congenital glaucoma, cloudy corneas. https://www.aao.org/image/congenital-glaucoma-cloudy-corneas-2 Accessed July 01, 2019
    Results Reference
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    Iris Tissue in Primary Congenital Glaucoma

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