Histopathological Examination of Iris Tissue in Buphthalmos

July 4, 2019 updated by: Hassan Lotfy Fahmy, Assiut University
To revise the etiology of the primary congenital glaucoma in some infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infants under age of 2 years
  • 1ery glaucoma

Exclusion Criteria:

  • infants more than 2 years
  • 2ery glaucoma
  • previous glaucoma surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2323299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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