NCT02309736

Brief Summary

The objective of the study is to 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

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

First QC Date

December 3, 2014

Last Update Submit

February 3, 2020

Conditions

Endophthalmitis

Outcome Measures

Primary Outcomes (1)

  • Occurrence of endophthalmitis

    Day 30

Interventions

ReSure SealantDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
All patients that receive at least one application of the ReSure Sealant on the operative eye following cataract surgery will be enrolled.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases
0

Study Design

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

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Primary Completion

April 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02