The ReSure Sealant is a first-of-a-kind ocular sealant proven in a U.S. clinical trial to be safe and effective in sealing clear corneal incisions following cataract surgery. Composed of a synthetic, polyethylene glycol hydrogel, the product is approximately 90% water after polymerization.
The ReSure Sealant is prepared and applied in approximately 20 seconds and gels in situ, protecting incisions in the immediate post-operative period when wounds are most vulnerable.1 The hydrogel contains a blue visualization aid to assist with ease of placement over the incision, and dissipates within hours of application. The hydrogel gradually sloughs off in the tears during reepithelialization, so there is no need for removal of the device.
Types of Cataract Patients
Non-Compliant
Elderly
Nursing Home
Mentally Disabled*
Transient
Combo/
Previous Surgery
MIGS*
Tube Shunt*
PK & PRK*
LASIK*
Premium
Toric
Multifocal
Accommodating
Femtosecond*
Standard
Suture Replacement*
Wound Gape
High Myopes
Phaco Burns*
High Risk
Complex Cataract
Immunocompromised*
Diabetic*
Monocular*
Superior to Sutures
Leak Rates Following Device Placement
“After randomization and treatment, 12 of 295 eyes in the sealant group (4.1%) versus 60 of 176 eyes in the suture group (34.1%) exhibited wound leakage with provocation, a difference that was shown to be statistically significant (P < .0001), with the sealant demonstrating superiority to sutures for preventing wound leakage as tested. The overall incidence of adverse ocular events reported for patients treated with the sealant was significantly lower than for patients treated with sutures (P < .0001).”
– Cynthia Matossian MD
- Significantly fewer adverse events in the ReSure group vs. the suture group (p<0.0001).
- 94.1% of sealant cases were rated “easy” or “very easy” to use.
- No safety concerns were reported.
- Patients were comfortable overall.
Selective Adherence
“When applied, the hydrogel molds around the irregularities of the de-epithelialized tissue and adheres via “lock and key,” instead of binding chemically to the ocular surface. In the days following surgery, the product selectively adheres to the de-epithelialized tissue without any chemical reaction or toxicity. It is important to note, however, that the incision should not be further deepithelialized in order for the product to adhere.”
– Cynthia Matossian MD
Images courtesy of Deepinder Dhaliwal, M.D., University of Pittsburgh Medical Center
Complex Cataract Case
ReSure Sealant provided an effective alternative to sutures to ensure proper wound closure and stability at the conclusion of the case and maintained effectiveness until the wound was fully healed
Case courtesy of Terry Kim, M.D., Duke Eye Center
“A leaking clear corneal incision is fairly common but often ignored, which can potentially lead to complications and suboptimal outcomes. The ReSure Sealant has been proven to be a safe and effective safeguard against wound leakage in cataract surgery, giving the patient and surgeon enhanced peace of mind.”
– Terry Kim, MD, Duke University
ReSure Sealant – a New Standard
Currently, there is no standardized test methodology to evaluate wound integrity post-surgery, and despite the safety of cataract surgery, numerous studies have shown that wound leaks are common and often go unrecognized.2-5 Prevention of these leaks following cataract surgery is essential, as they are objective markers for infrequent but serious complications. Patients may also compromise the clear corneal incisions by touching or rubbing the eye. The ReSure Sealant optimizes post-operative care by:
- Providing comfortable wound closure for patients
- Preventing fluid egress from clear corneal incisions more effectively than sutures
- Avoiding suture-induced complications and device removal.
To learn more about the U.S. Pivotal Clinical Trial, visit Product and Safety Information.