NCT02868190

Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication

A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication (Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle glaucoma on one topical hypotensive medication

Detailed description

The study design is as follows: Prospective Subjects with medicated IOP \> 18 mmHg and ≤ 30 mmHg Subjects on one topical ocular hypotensive medication prior to stent implantation Implantation of two iStent devices (if IOP is \< 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued) IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP Diurnal IOP measurements Follow-up through 60 months postoperative (but could be up to 61 months if subject needs to undergo terminal washout) Descriptive statistics will be tabulated Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Two trabecular micro-bypass stents (iStent inject)	Standalone implantation of two trabecular micro-bypass stents (iStent inject)

Timeline

• Start date: 2013-03-01
• Primary completion: 2019-11-08
• Completion: 2019-11-08
• First posted: 2016-08-16
• Last updated: 2022-09-08

Locations

1 site across 1 country: Armenia