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Trial record 30 of 1614 for:    glaucoma

Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02260219
Recruitment Status : Unknown
Verified September 2014 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Active, not recruiting
First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Asociación para Evitar la Ceguera en México

Brief Summary:

Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage Device, model M4 compared with the model S2.

Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group (M4 and S2). They will be operated using conventional techniques and creating a sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be monitoring for one year and the results will be evaluated with respect to a postoperative reduction in pressure, changes in visual acuity, the need for drugs and complications, in addition to the demographic characteristics of each group.


Condition or disease Intervention/treatment Phase
Neovascular Glaucoma Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of the Safety and Efficacy of the Ahmed Glaucoma Valve Drainage Device, Model M4 (High Density Porous Polyethylene) and the Model S2 (Polypropylene) in Patients With Neovascular Glaucoma
Study Start Date : January 2012
Actual Primary Completion Date : February 2013


Arm Intervention/treatment
Active Comparator: S2
Surgically Implant an Ahmed Glaucoma Drainage Device Model S2 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP
Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2
Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP

Active Comparator: M4
Surgically Implant an Ahmed Glaucoma Drainage Device Model M4 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP
Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2
Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP




Primary Outcome Measures :
  1. Number of participants with adverse effects [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diagnosis of Neovascular glaucoma
  • High IOP despite topical treatment

Exclusion Criteria:

  • Pregnant women
  • Mental disorders
  • Previous glaucoma surgery
  • Patients older than 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260219


Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
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Study Director: Felix Gil-Carrasco, MD 52 55 10841400

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Responsible Party: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT02260219     History of Changes
Other Study ID Numbers: GL-12-01
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: September 2014

Keywords provided by Asociación para Evitar la Ceguera en México:
Ahmed implant
Neovascular Glaucoma
Intraocular pressure

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases