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Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00665756
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
Drug Information available for: Mitomycin
U.S. FDA Resources

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
Active Comparator: 1
second trabeculectomy
 Procedure: second Trabeculectomy
second trabeculectomy with mitomycin-c
Other Name: re-Trabeculectomy with mitomycin-C
Active Comparator: 2
Ahmed silicone drainage device implantation
 Procedure: Ahmed Implant
Ahmed silicone drainage device
Other Name: Armed FP-7 adult silicone valve

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:

  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.

  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
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:

Responsible Party: Augusto Paranhos Jr, PHD, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00665756     History of Changes
Other Study ID Numbers: GLAU0037
Study First Received: April 23, 2008
Last Updated: April 23, 2008
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

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on May 22, 2013