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

Vanak Eye Surgery Center1 site in 1 country72 target enrollmentJanuary 2003

ConditionsRefractory Glaucoma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Refractory Glaucoma
Sponsor: Vanak Eye Surgery Center
Enrollment: 72
Locations: 1
Primary Endpoint: Intra Ocular pressure (IOP)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

August 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vanak Eye Surgery Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Intra Ocular pressure (IOP)

Time Frame: Month 24

Secondary Outcomes

Intra Ocular pressure (IOP)(day 1,week 1, and months 1, 3, 6, 9, 12 and 18)
Changes in visual acuity(day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.)
Number of anti-glaucoma medications(week 1, and months 1, 3, 6, 9, 12, 18, and 24)
Mean deviation of visual field,(week 1, and months 1, 3, 6, 9, 12, 18, and 24)
Rate of intra- and postoperative complications(week 1, and months 1, 3, 6, 9, 12, 18, and 24)