Adverse Events Clinical Trial
— Clinical PASOfficial title:
ReSure Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
Verified date | December 2016 |
Source | Ocular Therapeutix, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 626 |
Est. completion date | April 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 22 Years and older |
Eligibility |
Inclusion Criteria: - Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement Exclusion Criteria: - ReSure Sealant is not applied to the operative eye |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ocular Therapeutix, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anterior chamber cells greater than level 1+ persisting at Visit 2 (= Day 20) | Post operative days 20 to 40 | Yes | |
Primary | Hypotony (= 5 mmHg) | Post operative days 20 to 40 | Yes | |
Primary | 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 | Yes |
Primary | Surgical reintervention | Surgical reintervention for management of a wound leak - Yes or No | Post operative days 20 to 40 | Yes |
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