VEGF in Iris Tissue in Primary Congenital Glaucoma

Sponsor

Hassan Lotfy Fahmy (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05484050

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.

Condition or Disease	Intervention/Treatment	Phase
Iris	Other: Immunohistochemistry analysis	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Estimation of Vascular Endothelial Growth Factor (VEGF) in Iris Tissue in Primary Congenital Glaucoma

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: VEGF in iris tissue in primary congenital glaucoma Estimation of VEGF grade in iris tissue in primary congenital glaucoma through Immunohistochemistry	Other: Immunohistochemistry analysis Estimation of VEGF through Immunohistochemistry
Other: VEGF in iris tissue from ocular trauma or congenital cataract Estimation of VEGF grade in iris tissue from ocular trauma or congenital cataract through Immunohistochemistry	Other: Immunohistochemistry analysis Estimation of VEGF through Immunohistochemistry

Arm

Intervention/Treatment

Other: VEGF in iris tissue in primary congenital glaucoma

Estimation of VEGF grade in iris tissue in primary congenital glaucoma through Immunohistochemistry

Other: Immunohistochemistry analysis

Estimation of VEGF through Immunohistochemistry

Other: VEGF in iris tissue from ocular trauma or congenital cataract

Estimation of VEGF grade in iris tissue from ocular trauma or congenital cataract through Immunohistochemistry

Other: Immunohistochemistry analysis

Estimation of VEGF through Immunohistochemistry

Outcome Measures

Primary Outcome Measures

VEGF [6 month]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

primary congenital glaucoma

Exclusion Criteria:

Infants with history of previous surgery.
Secondary glaucoma.
Glaucoma associated with other congenital anomalies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hassan Lotfy	Assiut		Egypt	7111

Sponsors and Collaborators

Hassan Lotfy Fahmy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hassan Lotfy Fahmy, Professor, Assiut University

ClinicalTrials.gov Identifier:

NCT05484050

Other Study ID Numbers:

2323300

First Posted:

Aug 2, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Hydrophthalmos

Study Results

No Results Posted as of Aug 2, 2022