Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSure Sealant | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20) | Post operative days 20 to 40 | |
| Hypotony (≤ 5 mmHg) | Post operative days 20 to 40 | |
| Ocular discomfort | Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8 | Post operative days 20 to 40 |
| Surgical reintervention | Surgical reintervention for management of a wound leak - Yes or No | Post operative days 20 to 40 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients treated with ReSure Sealant following cataract surgery
Not provided
Not provided
Not provided
Not provided