Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients - Full Text View

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00665756

Purpose

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.

Condition	Intervention
Open Angle Glaucoma	Procedure: second Trabeculectomy Procedure: Ahmed Implant

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Mitomycin Mitomycins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

intra ocular pressure [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

number of hypotensive medications [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	January 2006
Estimated Study Completion Date:	July 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator second trabeculectomy	Procedure: second Trabeculectomy second trabeculectomy with mitomycin-c
2: Active Comparator Ahmed silicone drainage device implantation	Procedure: Ahmed Implant Ahmed silicone drainage device

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665756

Locations

Brazil, SP
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023-062

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

Augusto Paranhos JR, PHD

Federal University of Sao Paulo

More Information

Publications of Results:

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.

Other Publications:

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.

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. Review.

Responsible Party:	Federal University of Sao Paulo ( Augusto Paranhos Jr, PHD )
Study ID Numbers:	GLAU0037, no
Study First Received:	April 23, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00665756
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health; Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:

Glaucoma
Drainage implant
Ahmed valve
Second trabeculectomy

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Mitomycin

Mitomycins
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

Antibiotics, Antineoplastic
Alkylating Agents
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009