Post Approval Study of the CyPass System
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 2/6/2019 |
| Start Date: | October 12, 2017 |
| End Date: | October 2021 |
Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery
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.
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.
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.
42 days between the screening and surgery visits, and 36 months of post-surgery follow-up.
Only one eye per subject will be implanted.
Inclusion Criteria:
- 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
- Diagnosis of primary open angle glaucoma (POAG)
- Medicated IOP of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of
≥21 mmHg and ≤33 mmHg
- An operable age-related cataract eligible for phacoemulsification
- Visual acuity as specified in the protocol
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Inability to complete a visual field test prior to surgery
- Use of ocular hypotensive medication/s, as specified in the protocol
- Diagnosis of glaucoma other than POAG, as specified in the protocol
- Other medical conditions, as specified in the protocol
- Proliferative diabetic retinopathy
- Previous surgery for retinal detachment
- Previous corneal surgery
- Wet age-related macular degeneration
- Poor vision in the non-study eye not due to cataract
- Significant ocular inflammation or infection within 30 days of screening visit
- Uncontrolled systemic diseases that may put the subject's health at risk and/or
prevent the subject from completing all study visits
- Women who are pregnant or nursing
- Other protocol-specified exclusion criteria may apply.
We found this trial at
22
sites
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