Post Approval Study of the CyPass System
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in the COMPASS (TMI-09-01) Trial.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Each subject's expected participation in the study is up to 37.5 months which includes up to 42 days between the screening and surgery visits, and 36 months of post-surgery follow-up. Only one eye per subject will be implanted.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CyPass System CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery |
Device: CyPass Micro-Stent implanted with CyPass 241-S applier
CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.
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Outcome Measures
Primary Outcome Measures
- Rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability as determined at Month 36 [Month 36 postoperative]
Clinically relevant complications related to the device, as specified in the protocol
Secondary Outcome Measures
- Mean change in intraocular pressure (IOP) from baseline at Month 36 [Month 36 postoperative]
IOP assessed by Goldman tonometry
- Proportion of subjects with IOP reduction ≥ 20% from baseline while using the same or fewer topical ocular hypotensive medications at Month 36 [Month 36 postoperative]
IOP assessed by Goldman tonometry
- Proportion of subjects who are not using ocular hypotensive medication with IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36 [Month 36 postoperative]
IOP assessed by Goldman tonometry
- Rate of occurrence of sight-threatening adverse events at Month 36 [Month 36 postoperative]
Sight-threatening adverse events, as specified in the protocol
- Rate of ocular secondary surgical interventions (SSI) at Month 36 [Month 36 postoperative]
- Rate of ocular SSIs associated with CyPass placement and stability at Month 36 [Month 36 postoperative]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits
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Diagnosis of primary open angle glaucoma (POAG)
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Medicated IOP of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg
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An operable age-related cataract eligible for phacoemulsification
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Visual acuity as specified in the protocol
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Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
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Inability to complete a visual field test prior to surgery
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Use of ocular hypotensive medication/s, as specified in the protocol
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Diagnosis of glaucoma other than POAG, as specified in the protocol
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Other medical conditions, as specified in the protocol
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Proliferative diabetic retinopathy
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Previous surgery for retinal detachment
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Previous corneal surgery
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Wet age-related macular degeneration
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Poor vision in the non-study eye not due to cataract
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Significant ocular inflammation or infection within 30 days of screening visit
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Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits
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Women who are pregnant or nursing
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Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Alcon Investigative Site | Phoenix | Arizona | United States | 85016 |
2 | Alcon Investigative Site | Orange | California | United States | 92868 |
3 | Alcon Investigative Site | Fort Collins | Colorado | United States | 80528 |
4 | Alcon Investigative Site | Jacksonville | Florida | United States | 32256 |
5 | Alcon Investigative Site | Panama City | Florida | United States | 32405 |
6 | Alcon Investigative Site | Gainesville | Georgia | United States | 30501 |
7 | Alcon Investigative Site | Marietta | Georgia | United States | 30060 |
8 | Alcon Investigative Site | Garden City | Kansas | United States | 67846 |
9 | Alcon Investigative Site | Fraser | Michigan | United States | 48026 |
10 | Alcon Investigative Site | Saint Louis | Missouri | United States | 63131 |
11 | Alcon Investivative Site | Saint Louis | Missouri | United States | 63141 |
12 | Alcon Investigative Site | Vineland | New Jersey | United States | 08361 |
13 | Alcon Investigative Site | Bala-Cynwyd | Pennsylvania | United States | 19004 |
14 | Alcon Investigative Site | Chambersburg | Pennsylvania | United States | 17201 |
15 | Alcon Investigative Site | Austin | Texas | United States | 78731 |
16 | Alcon Investigative Site | El Paso | Texas | United States | 79902 |
17 | Alcon Investigative Site | Houston | Texas | United States | 77030 |
18 | Alcon Investigative Site | Bellevue | Washington | United States | 98004-3012 |
19 | Alcon Investigative Site | Kenosha | Wisconsin | United States | 53142 |
20 | Alcon Investigative Site | Racine | Wisconsin | United States | 53405 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Sr. Clinical Trial Lead, Surgical, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLD122c-C001