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Trial record 2 of 6 for:    Recruiting, Not yet recruiting, Available Studies | Buphthalmos

Iris Tissue in Primary Congenital Glaucoma

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ClinicalTrials.gov Identifier: NCT04079725
Recruitment Status : Not yet recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Omar Abdelkarem Hasan, Assiut University

Brief Summary:
To present the histopathological features of the iris tissue in primary congenital glaucoma which may play a role in pathogenesis

Condition or disease Intervention/treatment Phase
Primary Congenital Glaucoma Procedure: Combined trabeculotomy-trabeculectomy with mitomycin c Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Histopathological Examination of Iris Tissue in Primary Congenital Glaucoma
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Experimental : Infants with primary congenital glaucoma Procedure: Combined trabeculotomy-trabeculectomy with mitomycin c
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
Other Name: Histopathological examination of iris tissue




Primary Outcome Measures :
  1. Present histopathological features of iris tissue in infants with primary congenital glaucoma which may play a role in pathogenesis [ Time Frame: 2 years ]
    Histopathological features of iris tissue in infants with primary congenital glaucoma who underwent Combined trabeculotomy-trabeculectomy with mitomycin C



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079725


Contacts
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Contact: Omar Abdelkarem Hasan, M.B.B.Ch. +201000525341 oabdelkarem@gmail.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Omar Abdelkarem Hasan, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04079725     History of Changes
Other Study ID Numbers: primary congenital glaucoma
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydrophthalmos
Glaucoma
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors