Clinical Trial: ReSure Sealant Device Exposure Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Device Exposure Registry: A Post-Approval Observational Registry of ReSure Sealant to Track the Incidence of Endophthalmitis After Sealing Corneal Incisions in Patients Un

Brief Summary: This is a prospective multicenter observational single arm post-approval registry that will collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.

Detailed Summary:
Sponsor: Ocular Therapeutix, Inc.

Current Primary Outcome: Occurrence of endophthalmitis [ Time Frame: Within 30 days of cataract procedure and application of ReSure Sealant ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ocular Therapeutix, Inc.

Dates:
Date Received: December 3, 2014
Date Started: January 2016
Date Completion: January 2019
Last Updated: February 14, 2017
Last Verified: February 2017