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

A

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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