Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients
Primary Purpose
Open Angle Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
second Trabeculectomy
Ahmed Implant
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Glaucoma, Drainage implant, Ahmed valve, Second trabeculectomy
Eligibility Criteria
Inclusion Criteria:
- Patients with open angle glaucoma and uncontrolled IOP despite the use of maximum tolerated glaucoma medication.
- Patients over 18 years old.
- Patients who can understand and sign the inform consent form.
Exclusion Criteria:
- Other forms of glaucoma other than open angle glaucoma; previous psiquiatric condition ;
- Patients who can understand and sign the inform consent form;
- visual acuity worse than hand motion;
- previous retina surgery with buckle implant
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
second trabeculectomy
Ahmed silicone drainage device implantation
Outcomes
Primary Outcome Measures
intra ocular pressure
Secondary Outcome Measures
number of hypotensive medications
Full Information
NCT ID
NCT00665756
First Posted
April 23, 2008
Last Updated
April 23, 2008
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00665756
Brief Title
Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients
Official Title
Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
July 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the management of open angle glaucoma, frequently more then one procedure is necessary to control the intra ocular pressure. There is still no consensus whether this second intervention should be a second trabeculectomy or a shunt device. In the present study we compare a second trabeculectomy versus Ahmed silicone shunt device in open angle glaucoma patients with previous trabeculectomy without proper IOP control.
Detailed Description
In the management of open angle glaucoma, frequently more then one procedure is necessary to control the intra ocular pressure. There is still no consensus whether this second intervention should be a second trabeculectomy or a shunt device. In the present study we compare a second trabeculectomy versus Ahmed silicone shunt device in open angle glaucoma patients with previous trabeculectomy without proper IOP control.
40 Patients with clinically uncontrolled open angle glaucoma with previous trabeculectomy surgery were selected from the glaucoma sector of Federal university of Sao Paulo. Patients were randomized to one of two groups:
Silicone Ahmed Implant
Second trabeculectomy
Surgery description:
Ahmed silicone tube implant: A fornix-based conjunctival flap was created between two adjacent recti muscles. Before placement of the tube implant body to the sclera, tube was irrigated with saline solution to open the valve mechanism. The implant's polypropylene body was sutured to sclera with 6.0 silk suture. The tube then trimmed and the anterior chamber was entered from 1mm posterior to corneoscleral limbus with 23-gauge needle. A human donor scleral flap was placed over the tube and sutured to the sclera with 10.0 nylon suture. The conjunctiva was sutured to the limbus.
Second Trabeculectomy: A fornix-based conjunctival flap was created in the opposite superior quadrant of the previous trabeculectomy. Mitomycin-C was used under the conjunctival flap for up to 4 minutes (0,3mg/mL) and rinsed with 30mL saline solution. Scleral flap with crescent bevel and sclerectomy with a punch. Iridectomy and flap suture with nylon 10-0. Conjunctival suture with nylon 10-0.
Follow up after surgery was in the 1st, 4th, 7th, 15th, 30th days and after that monthly or whenever needed for clinical reasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
Glaucoma, Drainage implant, Ahmed valve, Second trabeculectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
second trabeculectomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ahmed silicone drainage device implantation
Intervention Type
Procedure
Intervention Name(s)
second Trabeculectomy
Other Intervention Name(s)
re-Trabeculectomy with mitomycin-C
Intervention Description
second trabeculectomy with mitomycin-c
Intervention Type
Procedure
Intervention Name(s)
Ahmed Implant
Other Intervention Name(s)
Armed FP-7 adult silicone valve
Intervention Description
Ahmed silicone drainage device
Primary Outcome Measure Information:
Title
intra ocular pressure
Time Frame
Monthly
Secondary Outcome Measure Information:
Title
number of hypotensive medications
Time Frame
monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with open angle glaucoma and uncontrolled IOP despite the use of maximum tolerated glaucoma medication.
Patients over 18 years old.
Patients who can understand and sign the inform consent form.
Exclusion Criteria:
Other forms of glaucoma other than open angle glaucoma; previous psiquiatric condition ;
Patients who can understand and sign the inform consent form;
visual acuity worse than hand motion;
previous retina surgery with buckle implant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Augusto Paranhos JR, PHD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
16086949
Citation
Gedde SJ, Schiffman JC, Feuer WJ, Parrish RK 2nd, Heuer DK, Brandt JD; Tube Versus Trabeculectomy Study Group. The tube versus trabeculectomy study: design and baseline characteristics of study patients. Am J Ophthalmol. 2005 Aug;140(2):275-87. doi: 10.1016/j.ajo.2005.03.031.
Results Reference
background
PubMed Identifier
16625616
Citation
Minckler DS, Vedula SS, Li TJ, Mathew MC, Ayyala RS, Francis BA. Aqueous shunts for glaucoma. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004918. doi: 10.1002/14651858.CD004918.pub2.
Results Reference
background
PubMed Identifier
16877071
Citation
Ishida K, Netland PA, Costa VP, Shiroma L, Khan B, Ahmed II. Comparison of polypropylene and silicone Ahmed Glaucoma Valves. Ophthalmology. 2006 Aug;113(8):1320-6. doi: 10.1016/j.ophtha.2006.04.020.
Results Reference
result
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Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients
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