OTX-14-002: Device Exposure Registry
Sponsor
Ocular Therapeutix, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02309736
Collaborator
(none)
0
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
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
Anticipated Primary Completion Date
:
Apr 1, 2020
Outcome Measures
Primary Outcome Measures
- Occurrence of endophthalmitis [Day 30]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
All patients that receive at least one application of the ReSure Sealant on the operative eye following cataract surgery will be enrolled.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ocular Therapeutix, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:
NCT02309736
Other Study ID Numbers:
- OTX-14-002
First Posted:
Dec 5, 2014
Last Update Posted:
Feb 5, 2020
Last Verified:
Feb 1, 2020
Additional relevant MeSH terms: