N/A
Completed N=48
Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
Primary Open Angle Glaucoma (POAG)
Source: ClinicalTrials.gov NCT01166659 ↗
Enrolled (actual)
48
Serious AEs
10.2%
Results posted
Oct 2016
Primary outcomePrimary: 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
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
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 | — |
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
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. Informational only — not medical advice.