Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedApril 24, 2008
April 1, 2008
2.2 years
April 23, 2008
April 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intra ocular pressure
Monthly
Secondary Outcomes (1)
number of hypotensive medications
monthly
Study Arms (2)
1
ACTIVE COMPARATORsecond trabeculectomy
2
ACTIVE COMPARATORAhmed silicone drainage device implantation
Interventions
second trabeculectomy with mitomycin-c
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Sao Paulo
São Paulo, São Paulo, 04023-062, Brazil
Related Publications (3)
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.
PMID: 16086949BACKGROUNDMinckler 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.
PMID: 16625616BACKGROUNDIshida 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.
PMID: 16877071RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Augusto Paranhos JR, PHD
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 24, 2008
Study Start
January 1, 2006
Primary Completion
April 1, 2008
Study Completion
July 1, 2008
Last Updated
April 24, 2008
Record last verified: 2008-04