Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

Not Applicable

Completed

• Conditions: Open-angle Glaucoma
• Interventions: Device: Two iStent; Device: One iStent

• Registration Number: NCT01455467
• Lead Sponsor: Glaukos Corporation

Brief Summary

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
• Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

Exclusion Criteria

• Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
• Prior stent implantations (study eye)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two iStent	Two iStent	Implantation of two iStent devices in conjunction with cataract surgery
One iStent	One iStent	Implantation of one iStent in conjunction with cataract surgery

Primary Outcome Measures

Name	Time	Method
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP	12 Months

Trial Locations

Locations (1)

S.V. Malayan Ophthalmological Center; 🇦🇲 Yerevan, Armenia