Back to resultsVEGF in Iris Tissue in Primary Congenital Glaucoma
Primary Purpose
Iris
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Immunohistochemistry analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Iris
Eligibility Criteria
Inclusion Criteria:
- primary congenital glaucoma
Exclusion Criteria:
- Infants with history of previous surgery.
- Secondary glaucoma.
- Glaucoma associated with other congenital anomalies.
Sites / Locations
- Hassan Lotfy
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
VEGF in iris tissue in primary congenital glaucoma
VEGF in iris tissue from ocular trauma or congenital cataract
Arm Description
Estimation of VEGF grade in iris tissue in primary congenital glaucoma through Immunohistochemistry
Estimation of VEGF grade in iris tissue from ocular trauma or congenital cataract through Immunohistochemistry
Outcomes
Primary Outcome Measures
VEGF
Estimation of VEGF grade in iris tissue through Immunohistochemistry, The grades is arranged from 0 to 5, with 0 being the lowest level and 5 being the highest level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05484050
Brief Title
VEGF in Iris Tissue in Primary Congenital Glaucoma
Official Title
Estimation of Vascular Endothelial Growth Factor (VEGF) in Iris Tissue in Primary Congenital Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hassan Lotfy Fahmy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.
Detailed Description
Combined trabeculotomy with mitomycin C will done in infants with primary congenital glaucoma with histopathological examination of the the peripheral iris tissue specimen and vascular endothelial growth factor (VEGF) estimation in iris tissue specimen through Immunohistochemistry.
Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen taking from ocular trauma or congenital cataract used as control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iris
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VEGF in iris tissue in primary congenital glaucoma
Arm Type
Other
Arm Description
Estimation of VEGF grade in iris tissue in primary congenital glaucoma through Immunohistochemistry
Arm Title
VEGF in iris tissue from ocular trauma or congenital cataract
Arm Type
Other
Arm Description
Estimation of VEGF grade in iris tissue from ocular trauma or congenital cataract through Immunohistochemistry
Intervention Type
Other
Intervention Name(s)
Immunohistochemistry analysis
Intervention Description
Estimation of VEGF through Immunohistochemistry
Primary Outcome Measure Information:
Title
VEGF
Description
Estimation of VEGF grade in iris tissue through Immunohistochemistry, The grades is arranged from 0 to 5, with 0 being the lowest level and 5 being the highest level
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary congenital glaucoma
Exclusion Criteria:
Infants with history of previous surgery.
Secondary glaucoma.
Glaucoma associated with other congenital anomalies.
Facility Information:
Facility Name
Hassan Lotfy
City
Assiut
ZIP/Postal Code
7111
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan Lotfy, prof.
Phone
01020833002
Email
hassaniron57@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VEGF in Iris Tissue in Primary Congenital Glaucoma
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