ReSure Sealant Post Approval Study

Completed

• Conditions: Adverse Events

• Registration Number: NCT02310815
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 626

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Post operative days 20 to 40	Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8
Surgical reintervention	Post operative days 20 to 40	Surgical reintervention for management of a wound leak - Yes or No