Back to resultsEvaluation of Primary Congenital Glaucoma at Asyut University Hospital
Primary Purpose
Primary Congenital Glaucoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined trabeculotomy-trabeculectomy with mitomycin C
Sponsored by
About this trial
This is an interventional health services research trial for Primary Congenital Glaucoma
Eligibility Criteria
Inclusion Criteria:
Typical symptoms of epiphora , photophobia and blepharospasm Corneal diameter > 13 mm Increased ocular tension > 25 mmHg UGA using schiotz tonometer
Exclusion Criteria:
Infants with history of previous surgery Secondary glaucoma Glaucoma associated with other congenital anomalies
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infants with primary congenital glaucoma
Arm Description
Outcomes
Primary Outcome Measures
IOP follow up
postoperative measurment of Intra ocular pressure by shoitz tonometer
Secondary Outcome Measures
Full Information
NCT ID
NCT05205122
First Posted
January 11, 2022
Last Updated
January 11, 2022
Sponsor
Omar Abdelkarem Hasan
1. Study Identification
Unique Protocol Identification Number
NCT05205122
Brief Title
Evaluation of Primary Congenital Glaucoma at Asyut University Hospital
Official Title
Evaluation of Primary Congenital Glaucoma Management at Asyut University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omar Abdelkarem Hasan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of the management of primary congenital glaucoma regarding the results of surgical intervention at Asyut University Hospital
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Congenital Glaucoma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infants with primary congenital glaucoma
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Combined trabeculotomy-trabeculectomy with mitomycin C
Intervention Description
Combined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases
Primary Outcome Measure Information:
Title
IOP follow up
Description
postoperative measurment of Intra ocular pressure by shoitz tonometer
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Typical symptoms of epiphora , photophobia and blepharospasm Corneal diameter > 13 mm Increased ocular tension > 25 mmHg UGA using schiotz tonometer
Exclusion Criteria:
Infants with history of previous surgery Secondary glaucoma Glaucoma associated with other congenital anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Abdelkarem Hasan, M.B.B.Ch.
Phone
00201000525341
Email
oabdelkarem@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Primary Congenital Glaucoma at Asyut University Hospital
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