Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Registration Number
- NCT01166659
- Lead Sponsor
- Transcend Medical, Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Diagnosis of POAG
- Medicated IOP ≥ 21 and ≤ 35 mmHg
- Use of 1 - 4 topical IOP lowering medications
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Baseline; Month 12 postoperative IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.
- Secondary Outcome Measures
Name Time Method Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication Month 12 postoperative Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline Baseline, Month 12 postoperative The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.
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