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

Asociación para Evitar la Ceguera en México

Status: Terminated

Conditions: Neovascular Glaucoma

Treatments: Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2

Study type: Interventional

Funder types: Other

Identifiers

NCT02260219

GL-12-01

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

S2

Active Comparator group

Description:

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

Treatment:

Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2

M4

Active Comparator group

Description:

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

Treatment:

Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2