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Histopathological Examination of Iris Tissue in Buphthalmos

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04011878
Recruitment Status : Completed
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Information provided by (Responsible Party):
Hassan Lotfy Fahmy, Assiut University

Brief Summary:
To revise the etiology of the primary congenital glaucoma in some infants.

Condition or disease Intervention/treatment Phase
Iris Disease Procedure: Combined trabeculotomy trabeculectomy with mitomycin C Not Applicable

Detailed Description:
Combined trabeculotomy trabeculectomy with mitomycin C was done in 11 eyes. Histopathological examination of the peripheral iris tissue specimen was done in all cases.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Histopathological Examination of Iris Tissue in Buphthalmos
Actual Study Start Date : January 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: isolated trabeculodysgensis
etiology of primary congenital glaucoma
Procedure: Combined trabeculotomy trabeculectomy with mitomycin C
Combined trabeculotomy trabeculectomy with mitomycin C with histopathological examination of the peripheral iris tissue specimen of all cases

Primary Outcome Measures :
  1. fibrovascular membrane over iris surface [ Time Frame: 6 month ]
    angle closure by a fibrovascular tissue proliferation over the trabecular meshwork in the anterior chamber angle.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • infants under age of 2 years
  • 1ery glaucoma

Exclusion Criteria:

  • infants more than 2 years
  • 2ery glaucoma
  • previous glaucoma surgery
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Responsible Party: Hassan Lotfy Fahmy, Prof., Assiut University Identifier: NCT04011878    
Other Study ID Numbers: 2323299
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Iris Diseases
Eye Abnormalities
Eye Diseases
Glaucoma, Open-Angle
Ocular Hypertension
Congenital Abnormalities
Infant, Newborn, Diseases
Uveal Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors