CompletedNot Applicable

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

48 participantsStarted 2010-02

Plain-language 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

Who can participate

Age range21 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Baseline; Month 12 postoperative

Trial details

NCT IDNCT01166659

SponsorTranscend Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05

Results submitted2016-08-25

View on ClinicalTrials.gov More Primary Open Angle Glaucoma (POAG) trials