Back to resultsComparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma
Primary Purpose
Congenital Glaucoma
Status
Unknown status
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Deep Sclerectomy
Combined Trab
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
- Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
- Within the age of (0 - 12).
Exclusion Criteria:
- Cases of congenital glaucoma with previous intervention.
- Age above 12 Yrs.
- Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
Sites / Locations
- King Abdul Aziz University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
DS arm
Trab arm
Arm Description
Deep sclerectomy surgery will be conduct in this arm
combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm
Outcomes
Primary Outcome Measures
reduction in IOP
decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg
Secondary Outcome Measures
Full Information
NCT ID
NCT01460017
First Posted
October 25, 2011
Last Updated
October 25, 2011
Sponsor
King Saud University
1. Study Identification
Unique Protocol Identification Number
NCT01460017
Brief Title
Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma
Official Title
Comparison Between The Outcome of Deep Sclerectomy and Traditional Trabeculotomy and Trabeculectomy Surgeries in Congenital Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.
Detailed Description
Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DS arm
Arm Type
Active Comparator
Arm Description
Deep sclerectomy surgery will be conduct in this arm
Arm Title
Trab arm
Arm Type
Active Comparator
Arm Description
combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm
Intervention Type
Procedure
Intervention Name(s)
Deep Sclerectomy
Other Intervention Name(s)
Non penetrating DS
Intervention Description
Non penetrating glaucoma surgery is a new procedure in adults that has less post operative complications with good results, it is to be applied in children.
Intervention Type
Procedure
Intervention Name(s)
Combined Trab
Other Intervention Name(s)
Combined Trabeculectomy Trabeculotomy
Intervention Description
Combined trabeculectomy and trabeculotomy is a standard surgery for congenital glaucoma, however, it has its known complications.
Primary Outcome Measure Information:
Title
reduction in IOP
Description
decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
Within the age of (0 - 12).
Exclusion Criteria:
Cases of congenital glaucoma with previous intervention.
Age above 12 Yrs.
Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saleh A. Al-Obeidan, MD
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdul Aziz University Hospital
City
Riyadh
ZIP/Postal Code
11411
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saleh A. Al-Obeidan, MD
Phone
+96614786100
Ext
1425
Email
alobeidan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Essam A. Osman, FRCS
Phone
+966507449080
Email
essam.osman065@gmail.com
First Name & Middle Initial & Last Name & Degree
Essam A. Osman, FRCS
First Name & Middle Initial & Last Name & Degree
Ahmed M Abdel-Rahim, Ph. D.
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma
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