Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma

Vanak Eye Surgery Center

Status and phase: Completed; Phase 3

Conditions: Refractory Glaucoma

Treatments: Device: Ahmed valve implant; Device: Molteno single-plate implant (MSPI)

Study type: Interventional

Funder types: Other

Identifiers

NCT00971061

1465087

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.

Enrollment: 72 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.

Exclusion criteria

• age less than 40 years
• a visual acuity of no light perception
• lens opacity
• elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
• previous cyclodestructive treatment
• increased risk of endophthalmitis posterior segment disorders
• pre-existing ocular comorbidities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

MSPI

Experimental group

Description:

Molteno single-plate implant

Treatment:

Device: Molteno single-plate implant (MSPI)

AVI

Active Comparator group

Description:

Ahmed valve implant

Treatment:

Device: Ahmed valve implant