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Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

Open-angle Glaucoma Clinical Trial

Official title:
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin

Clinical Trial Summary

The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.

Clinical Trial Description

The study design is as follows: - Prospective, single-arm study. - Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg. - Subjects on two topical ocular hypotensive medications (one a prostaglandin). - Implantation of two iStent inject 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. - Follow-up through 60 months postoperative (or 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02873806
Study type Interventional
Source Glaukos Corporation
Contact
Status Completed
Phase Phase 4
Start date March 2013
Completion date November 8, 2019
View Details
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