ReSure Sealant Pivotal Study

Completed · Phase 3

Conditions studied: Cataract Surgery Incision Leak

In brief

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.

Key facts

Study ID

NCT01498224

Run by

Ocular Therapeutix, Inc.

People needed

488

Starts

2011-12-01

Expected to finish

2012-11-01

Last updated by the study team

2016-12-12

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Levenson Eye Associates — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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