Status:
COMPLETED
ReSure Sealant Pivotal Study
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Cataract Surgery Incision Leak
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief Summary
This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.
Eligibility Criteria
Inclusion
- Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens
- Subject must be 22 years of age or older
Exclusion
- Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment
- Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT01498224
Start Date
December 1 2011
End Date
November 1 2012
Last Update
December 12 2016
Active Locations (1)
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1
Levenson Eye Associates
Jacksonville, Florida, United States, 32204