A multicentre registry study to capture data with respect to CyPass clinical experience (CYCLE)
Completed
- Conditions
- GlaucomaEye Diseases
- Registration Number
- ISRCTN74288501
- Lead Sponsor
- Transcend Medical, Inc.™ (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1. Able to understand study requirements and willing to follow study instructions and provide written consent
2. Diagnosis of glaucoma in the study eye
3. At the preoperative visit, a mean medicated or unmedicated intraocular pressure (IOP) in the study eye of greater than or equal to 18 mmHg and less than or equal to 44 mmHg
Exclusion Criteria
1. Diagnosis of acute angle closure, narrow angle, uveitic or neovascular glaucoma in the study eye
2. Diagnosis of normal tension glaucoma in the study eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety outcomes: Incidence of intra-operative and post-operative adverse events
- Secondary Outcome Measures
Name Time Method Effectiveness Outcomes: <br>1. Mean change in IOP from baseline to 1 month post-operatively, and beyond<br>2. Mean change in required glaucoma medications used from baseline to 1 month<br>post-operatively, and beyond