Back to resultsVisco-Circumferential-Suture-Trabeculotomy Versus Trabeculotomy
Primary Purpose
Primary Congenital Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
trabeculotomy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Congenital Glaucoma
Eligibility Criteria
Inclusion Criteria:
- infants below the age of 2 years with PCG
Exclusion Criteria:
- patients older than 2 years on presentation
- eyes with previous surgery
- eyes with secondary glaucoma
- eyes diagnosed as anterior segment dysgenesis syndrome
Sites / Locations
- Ophthalmic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visco-Circumferential-Suture-Trabeculotomy
viscotrabeculotomy
Arm Description
Visco-Circumferential-Suture-Trabeculotomy
Viscotrabeculotomy
Outcomes
Primary Outcome Measures
IOP
intraocular pressure measuring
Secondary Outcome Measures
complications
visual devastating complications
Full Information
NCT ID
NCT04683289
First Posted
December 19, 2020
Last Updated
December 24, 2020
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT04683289
Brief Title
Visco-Circumferential-Suture-Trabeculotomy Versus Trabeculotomy
Official Title
Surgical Outcomes of Visco-Circumferential-Suture-Trabeculotomy in Primary Congenital Glaucoma: A 3-year Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
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
comparing outcomes of Visco-Circumferential-Suture-Trabeculotomy in primary congenital glaucoma to trabeculotomy
Detailed Description
prospective randomized interventional study conducted on infants below the age of 2 years with PCG attending the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University were recruited to compare the long-term surgical outcomes of this proposed technique (VCST) and rigid probe VT in patients with PCG.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visco-Circumferential-Suture-Trabeculotomy
Arm Type
Experimental
Arm Description
Visco-Circumferential-Suture-Trabeculotomy
Arm Title
viscotrabeculotomy
Arm Type
Active Comparator
Arm Description
Viscotrabeculotomy
Intervention Type
Procedure
Intervention Name(s)
trabeculotomy
Intervention Description
performing partial unroofing of the SC and viscoelastic injection into the 2 ostia of the canal. This was followed by connecting the scalemm canal to the anterior chamber
Primary Outcome Measure Information:
Title
IOP
Description
intraocular pressure measuring
Time Frame
36 months
Secondary Outcome Measure Information:
Title
complications
Description
visual devastating complications
Time Frame
36 months months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infants below the age of 2 years with PCG
Exclusion Criteria:
patients older than 2 years on presentation
eyes with previous surgery
eyes with secondary glaucoma
eyes diagnosed as anterior segment dysgenesis syndrome
Facility Information:
Facility Name
Ophthalmic Center
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Visco-Circumferential-Suture-Trabeculotomy Versus Trabeculotomy
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