ReSure Sealant Post Approval Study (Clinical PAS)

Ocular Therapeutix

Status: Completed

Conditions: Adverse Events

Treatments: Device: ReSure Sealant

Study type: Observational

Funder types: Industry

Identifiers

NCT02310815

OTX-13-003

Details and patient eligibility

About

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.

Enrollment: 626 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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