UBM Guided Site and Extent of Trabeculotomy in Pediatric Glaucoma (UBM)
Primary Purpose
Glaucoma Pediatric
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
trabeculotomy ( angle glaucoma surgery )
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma Pediatric
Eligibility Criteria
Inclusion Criteria:
- All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma
Exclusion Criteria:
patients refusing the study
Sites / Locations
- Dina Abd Elfattah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pediatric glaucoma patients either primary or secondary
Arm Description
All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma
Outcomes
Primary Outcome Measures
Intraocular pressure
success of glaucoma surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT05530031
First Posted
September 3, 2022
Last Updated
September 3, 2022
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT05530031
Brief Title
UBM Guided Site and Extent of Trabeculotomy in Pediatric Glaucoma
Acronym
UBM
Official Title
UBM Guided Site and Extent of Trabeculotomy in Pediatric Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
Different types of surgery are applied in PCG, including goniotomy, trabeculotomy, glaucoma drainage devices and trabeculectomy. UBM examination of the anterior chamber before surgery can help in the decision to what type of surgery is best for the patient. Aim of the work To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.
Detailed Description
To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma Methods
History taking:
Family history of ocular pathologies or syndromes.
Age at which the mother noticed ocular affection, time and type of intervention.
Onset of IOP elevation, IOP lowering medications used and any previous surgical intervention for glaucoma.
Preoperative examination & assessment
Examination under anaesthesia for state of the conjunctiva, conreal incision scars, corneal diameter, Haab's stria, broad limbus, anterior chamber depth, regularity and content, pupil shape, centration and response to mydriatics, IOL position and status in pseudophakic cases, IOP value, optic nerve cupping.
A scan for axial length and central corneal thickness.
B scan ultrasonography.
UBM : full detailed anterior segment examination will be done including : trabecular iris angle width , presence of abnormal iris insertion , abnormal membranes , Schlemm canal studying and iris thickness. All these parameters will be recorded for all 4 quadrants to select the most appropriate site of trabeculotomy.
Procedure
• trabeculotomy (with Metal Trabeculotome): a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.
Follow up
Postoperative visits planned on the first day, first week, second week, at first month, three months and six months.
Outcome measures included the IOP value at each visit, corneal diameters, cup disc ratio if accessible, the number of glaucoma medications used, the number and kind of complications.
Surgical success was defined as:
Complete sucess when IOP >5mmHg and ≤21mmHg or 30% IOP reduction from baseline and without any further IOP-lowering surgery.
Qualitative success when IOP ≤21mmHg or 30% IOP reduction from baseline but with the use of IOP lowering medications.
Failure is defined as:
IOP more than 21mmHg despite the use of IOP lowering medications.
Hypotony: IOP ≤5mmHg persistent for more than two weeks.
Need for other glaucoma surgery to control IOP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
• trabeculotomy (with Metal Trabeculotome): a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pediatric glaucoma patients either primary or secondary
Arm Type
Experimental
Arm Description
All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma
Intervention Type
Procedure
Intervention Name(s)
trabeculotomy ( angle glaucoma surgery )
Intervention Description
a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
success of glaucoma surgery
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma
Exclusion Criteria:
patients refusing the study
Facility Information:
Facility Name
Dina Abd Elfattah
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35100
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Abd Elfattah, MD
Phone
+201001951177
Ext
+2
Email
dinaabdelfattah@mans.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
results
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UBM Guided Site and Extent of Trabeculotomy in Pediatric Glaucoma
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