N/A N=48 Treatment

Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy

Primary Open Angle Glaucoma (POAG)

Bottom Line

View on ClinicalTrials.gov: NCT01166659 ↗

Enrolled (actual)

Serious AEs

10.2%

Results posted

Oct 2016

Primary outcome: Primary: Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline — 60.4 percentage of eyes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CyPass Micro-Stent (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Transcend Medical, Inc.
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline	60.4	—
SECONDARY Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication	81.4	—
SECONDARY Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline	2.1; 1.4	—

Summary

The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Eligibility Criteria

Inclusion Criteria

Diagnosis of POAG
Medicated IOP ≥ 21 and ≤ 35 mmHg
Use of 1 - 4 topical IOP lowering medications

Exclusion Criteria

Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Use of oral hypotensive medication treatment for glaucoma
Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
Clinically significant ocular pathology other than POAG

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01166659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.