Clinical Trials Directory

Trials / Completed

CompletedNCT02310815

ReSure Sealant Post Approval Study

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

Status
Completed
Phase
Study type
Observational
Enrollment
626 (actual)
Sponsor
Ocular Therapeutix, Inc. · Industry
Sex
All
Age
22 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEReSure Sealant

Timeline

Start date
2014-12-01
Primary completion
2016-02-01
Completion
2016-04-01
First posted
2014-12-08
Last updated
2016-12-05

Source: ClinicalTrials.gov record NCT02310815. Inclusion in this directory is not an endorsement.

ReSure Sealant Post Approval Study (NCT02310815) · Clinical Trials Directory