- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011878
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
|
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
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
- Eye Diseases
- Congenital Abnormalities
- Ocular Hypertension
- Eye Abnormalities
- Glaucoma, Open-Angle
- Infant, Newborn, Diseases
- Uveal Diseases
- Glaucoma
- Hydrophthalmos
- Iris Diseases
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Alkylating Agents
- Antibiotics, Antineoplastic
- Mitomycins
- Mitomycin
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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