NCT02310815

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

December 3, 2014

Last Update Submit

December 2, 2016

Conditions

Adverse Events

Outcome Measures

Primary Outcomes (4)

  • 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

    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

  • Surgical reintervention

    Surgical reintervention for management of a wound leak - Yes or No

    Post operative days 20 to 40

Interventions

ReSure SealantDEVICE

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with ReSure Sealant following cataract surgery

You may qualify if:

  • Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement

You may not qualify if:

  • ReSure Sealant is not applied to the operative eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 8, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

December 5, 2016

Record last verified: 2016-12