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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02260219

Enrollment

Registered

2014-10-09

Start date

2012-01-31

Completion date

2013-02-28

Last updated

2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Glaucoma

Keywords

Ahmed implant, Neovascular Glaucoma, Intraocular pressure

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.

Interventions

PROCEDURESurgical 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse effects	1 year

Secondary

Measure	Time frame
Intraocular pressure	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026