- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02309736
OTX-14-002: Device Exposure Registry
February 3, 2020 updated by: Ocular Therapeutix, Inc.
Device Exposure Registry: A Post-Approval Observational Registry of ReSure Sealant to Track the Incidence of Endophthalmitis After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
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
Study Overview
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Description
All patients that receive at least one application of the ReSure Sealant on the operative eye following cataract surgery will be enrolled.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of endophthalmitis
Time Frame: Day 30
|
Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Anticipated)
April 1, 2020
Study Registration Dates
First Submitted
December 3, 2014
First Submitted That Met QC Criteria
December 3, 2014
First Posted (Estimate)
December 5, 2014
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 3, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OTX-14-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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