Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma

ConditionGlaucoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age35+

SponsorGlaukos Corporation

About this trial

Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of primary open-angle glaucoma

Phakic or pseudophakic

Age 35 years or older

Disqualifiers

Traumatic, uveitic, neovascular, angle-closure glaucoma or

glaucoma associated with vascular disorders

Active corneal inflammation or edema

Retinal disorders not associated with glaucoma

Trial design

Design model

Single group

Treatments tested in this trial

iStent Infinite
Device
iStent Infinite Trabecular Micro-Bypass System

Treatment groups

245 Participants

are divided into 1 treatment group

Group A: iStent InfiniteExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline

Time frame

12 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Glaukos Corporation

Lead sponsor

Source ClinicalTrials.gov

Apply now