A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT00326014
• Date of registration: 12/05/2006
• Prospective Registration: No
• Primary sponsor: Glaukos Corporation
• Public title: A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
• Scientific title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
• Date of first enrolment: April 2003
• Target sample size: 58
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00326014
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Germany, Spain, Switzerland

Contacts

• Name: Head of clinical Affairs
• Affiliation: Glaukos Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with primary open-angle glaucoma (POAG)

- Subject on at least one glaucoma medication

- Patient requiring cataract surgery and an intraocular lens implantation

Exclusion Criteria:

- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt
implant, collagen implant, cyclo destructive procedures etc)

- Angle closure glaucoma



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Open-Angle Glaucoma

Intervention(s)

Device: iStent

Primary Outcome(s)

Efficacy [Time Frame: 24 months]

Secondary ID(s)

GC-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors