One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2022
• Main ID: NCT01517477
• Date of registration: 23/01/2012
• Prospective Registration: No
• Primary sponsor: Glaukos Corporation
• Public title: One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
• Scientific title: A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
• Date of first enrolment: January 2012
• Target sample size: 119
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01517477
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Armenia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with primary open-angle glaucoma (POAG)

- Subject on two topical hypotensive medications

Exclusion Criteria:

- Traumatic, uveitic, neovascular, or angle closure glaucoma

- Fellow eye already enrolled



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

Health Condition(s) or Problem(s) studied

Primary Open Angle Glaucoma (POAG)

Intervention(s)

Device: iStent

Primary Outcome(s)

Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline [Time Frame: 12 Months]

Secondary Outcome(s)

Mean diurnal IOP <18 mmHg at month 12 [Time Frame: 12 months]

Secondary ID(s)

GCF-033

Source(s) of Monetary Support

Please refer to primary and secondary sponsors