Leak rates following device* placement1
*Device refers to ReSure Sealant or suture.
Cumulative leak rates prior to device placement1
- Spontaneous Leak – 48.8% (244/500†)
- Spontaneous or w/ minimal touch (≤ 0.25 ounce of force) – 74.2% (371/500†)
†Wound leak was required for study entry; 12 patients had no wound leak with up to 1.0 oz of applied force.
Pivotal Trial Design1,2
A prospective, randomized (5:3), parallel-arm, controlled, multicenter, subject-masked study
Inclusion Criteria
- Patients scheduled for routine cataract surgery (single-plane clear corneal incisions 3.5 mm or less in length) with no confounding ocular pathology
- Wound leak shown following IOL placement
- Unprovoked or following first wound challenge test (Seidel) of up to 1.0 oz of force
Exclusion Criteria
- Patients with nonroutine cataract surgery or confounding ocular pathology
- Wound leak not shown following IOL placement
- Unprovoked or following first wound challenge test (Seidel) of up to 1.0 oz of force
ReSure Sealant was superior to a suture for mitigation of cataract incision leaks1,2†
Pivotal Trial
ReSure Sealant group had significantly fewer ocular adverse events vs. suture group1‡
No serious adverse ocular event was device-related1§
Most commonly reported ocular Adverse Events occurring in ≥1% patients2
‡P<0.0001
§As determined by the study investigator
‖Best corrected visual acuity
References: 1. Masket S, et al. J Cataract Refract Surg. 2014;40(12):2057-2066. 2. ReSure Sealant [instructions for use]. Bedford, MA: Ocular Therapeutix, Inc; LCN 80-1004-011 Rev D.