ReSure Sealant Post Approval Study

Adverse Events Clinical Trial

— Clinical PAS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310815
• Other study ID #: OTX-13-003
• Status: Completed
• Phase: N/A
• First received: December 3, 2014
• Last updated: December 2, 2016
• Start date: December 2014
• Est. completion date: April 2016

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Events

Intervention

Device:
• ReSure Sealant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Outcome

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