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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130004 / PAS002 |
| Date Original Protocol Accepted |
01/08/2014
|
| Date Current Protocol Accepted |
10/02/2014
|
| Study Name |
Clinical PAS
|
| Device Name |
RESURE SEALANT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with ReSure Sealant when used by a broad group of physicians under commercial use conditions.
Prospective multicenter observational post-approval study that will be conducted at a minimum of 20 centers and up to 40 centers in the United States with enrollment of at least 598 sequentially-enrolled patients treated with ReSure Sealant. An expected minimum of 10 patients and a maximum of
60 patients may be enrolled at any one site.
|
| Study Population |
Adult patients undergoing cataract surgery using the surgeon¿s standard techniqu treated with ReSure Sealant.
|
| Sample Size |
A sample size of 598 achieves an alpha of 0.05 and 80% power to detect a difference (P1-P0) of -0.025 using a one-sided binomial test, where P0 is the proportion of individual primary endpoint adverse ocular events in the postoperative follow-up period under the null hypothesis (0.075) and P1 is the proportion of individual primary endpoint adverse ocular events under the alternative hypothesis (0.050). These results assume that the population proportion under the null hypothesis is 0.075.
|
| Key Study Endpoints |
The primary endpoints will be the following Adverse Ocular Events occurring in the postoperative follow-up period:
¿Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)
¿Hypotony (≤ 5 mmHg)
¿Ocular discomfort (an OCI score greater than 51.7 or a within-person increase from baseline of greater than 37.8)
¿Surgical reintervention
|
| Follow-up Visits and Length of Follow-up |
4 weeks post-procedure
Subjects will be evaluated in the immediate postoperative period (Visit 1: Day 1 to Day 3) and again at approximately 4 weeks post-procedure (Visit 2: Day 20 to Day 40).
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
626 subjects
|
| Actual Number of Sites Enrolled |
22 sites
|
| Patient Follow-up Rate |
98.9%
|
| Final Safety Findings |
Event rates for each primary endpoint are as follows: anterior chamber cells greater than level 1+ persisting at visit 2 (greater than or equal to Day 20) 0.8%; hypotony 0%; ocular discomfort 0.6%; surgical reintervention 0.5%. For each of the individual primary endpoints, the upper confidence bound was well below the threshold of 7.5%. Therefore, the null hypothesis is rejected and it can be concluded that the true proportion for each individual primary endpoint is less than 7.5%.
|
| Final Effect Findings |
Effectiveness was not evaluated in the PAS.
|
| Study Strengths & Weaknesses |
Study strengths include this study being a large-scale prospective study of 626 patients from 22 U.S. sites. The large sample size from varied regions of the U.S. increases the generalizeability of the study results to patients at large undergoing cataract surgery in the U.S.
|
| Recommendations for Labeling Changes |
No
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