|
|
| General |
| Study Status |
Progress Adequate |
| Application Number |
P150037 / PAS002 |
| Date Current Protocol Accepted |
08/18/2017
|
| Study Name |
OSB Lead-CyPass Micro Stent New Enrollment PAS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Design Description |
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.
This is a prospective, non-randomized, multicenter, single arm, post approval study of the CyPass System. This is a new enrollment study that is expected to last up to 37.5 months and include 10 study visits.
|
| Study Population Description |
Adults who must have Primary Open Angle Glaucoma (POAG) in the study eye and also be undergoing cataract surgery in that eye. No comparator group.
Inclusion criteria:
1. Adults, 45 years of age or older at the time of surgery
2. 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
3. Diagnosis of primary open angle glaucoma (POAG) substantiated using funduscopic exam and at least one reliable visual field test with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm. Mean deviation score must be greater than or equal to-12.0 dB and less than 0 dB. The visual field test may be historical (up to 6 months prior to screening – Visit 0). If needed, visual field testing may be repeated between screening (Visit 0) and surgery (Visit 00). NOTE: A reliable visual field test is defined as one in which fixation losses (FL) are less than or equal to 20% and the false positive (FP) response rate is less than or equal to 15% (Rao 2015).
4. Medicated intraocular pressure (IOP) of greater than or equal to 10 mmHg and less than or equal to 25
mmHg, or an unmedicated IOP of greater than or equal to 21 mmHg and less than or equal to 33 mmHg
5. Gonioscopy confirming normal angle anatomy
6. Shaffer grade of greater than or equal to III in all four quadrants
7. An operable age-related cataract with best corrected distance visual acuity (BCDVA) of 0.3 logMAR or worse (less than or equal to 85 letters read), eligible for phacoemulsification. If the BCDVA is better than 0.3 logMAR (greater than 85 letters read), testing with a Brightness Acuity Meter (BAT) on a medium setting must result in a BCDVA of 0.3 logMAR or worse (less than or equal to 85 letters read).
8. An intact and centered capsulorhexis or capsulotomy
9. An intact posterior capsular bag
10. A well-centered IOL implant placed in the capsular bag
11. A clear view of an open angle and visualization of the angle with direct gonioscopy post intracameral miotic instillation
12. No evidence of zonular dehiscence/rupture (uncomplicated cataract extraction)
|
| Sample Size |
640 subjects will be enrolled, 360 eyes of 360 subjects (limit one eye per subject) will complete the study and provide 36- month data for statistical analyses at approximately 20 sites (approximately 22 subjects implanted per site).
|
| Data Collection |
Primary Effectiveness Endpoints: None.
Secondary Effectiveness Endpoints:
All secondary effectiveness endpoints will be evaluated at 36 months postoperatively.
Mean change in IOP
Proportion of subjects with IOP reduction greater than or equal to 20% while using the same or fewer topical ocular hypotensive medications
Proportion of subjects who are not using ocular hypotensive medication with IOP greater than or equal to 6mmHg and less than or equal to 18 mmHg
Primary Safety Endpoints:
The rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability as determined at 36 months. Specific device-related complications include:
Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass.
Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that:
The device is not in the supraciliary space, or
There is a clinical sequela resulting from device position including, but not limited to:
¿ Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation)
¿ Corneal endothelial touch by device
¿ Corneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit, in comparison with preoperative BCDVA
¿ Progressive endothelial cell loss (ECL), defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening endothelial cell density (ECD) value
¿ Erosion of device through sclera
¿ Device obstruction requiring secondary surgical intervention.
Secondary Safety Endpoints:
All secondary safety endpoints will be evaluated at 36 months postoperatively.
Rate of occurrence of sight-threatening adverse events including
Persistent (at time of study exit) BCDVA loss of 3 or more lines compared to best BCDVA achieved during the course of study
Endophthalmitis
Corneal decompensation
Retinal detachment
Severe choroidal hemorrhage or detachment o Aqueous misdirection
The rate of ocular secondary surgical interventions (SSI)
The rate of ocular SSIs associated with CyPass placement and stability
Other Safety Endpoints:
All other safety endpoints will be evaluated at 36 months postoperatively.
Increase from baseline IOP of 10 mmHg or greater at any time at/after 30 days postoperative
BCDVA loss of 2 or more lines compared to screening (Visit 0)
BCDVA loss of 2 or more lines in comparison with best recorded BCDVA at any postoperative visit
Device movement, defined as a change by at least 1 in the number of CyPass rings visible (e.g., from 1 ring to 2 rings or from 3 rings to 2 rings) that does not result in clinical sequelae (e.g., secondary surgical intervention to modify device position, corneal endothelial touch by device, corneal edema leading to loss of BCDVA > 2 lines at the last postoperative visit in comparison with preoperative BCDVA, progressive endothelial cell loss, erosion of device through sclera, or device obstruction requiring secondary surgical intervention), and that is not attributable to any one or
more of the following:
variations in gonioscopic viewing angle or illumination
changes in angle anatomy due to concomitant findings such as resolution of hyphema
changes in anterior chamber depth
development of focal peripheral anterior synechiae
|
| Follow-up Visits and Length of Follow-up |
36 months
|
|
