Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients
NCT ID: NCT00665756
Last Updated: 2008-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2006-01-31
2008-07-31
Brief Summary
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Detailed Description
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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:
1. Silicone Ahmed Implant
2. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
second trabeculectomy
second Trabeculectomy
second trabeculectomy with mitomycin-c
2
Ahmed silicone drainage device implantation
Ahmed Implant
Ahmed silicone drainage device
Interventions
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second Trabeculectomy
second trabeculectomy with mitomycin-c
Ahmed Implant
Ahmed silicone drainage device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients over 18 years old.
* Patients who can understand and sign the inform consent form.
Exclusion Criteria
* Patients who can understand and sign the inform consent form;
* visual acuity worse than hand motion;
* previous retina surgery with buckle implant
18 Years
80 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Federal University of Sao Paulo
Principal Investigators
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Augusto Paranhos JR, PHD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
Other Identifiers
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GLAU0037
Identifier Type: -
Identifier Source: org_study_id