FDA Approves ReSure Sealant for the Prevention of Aqueous Fluid Leaks Following Cataract Surgery
For years ophthalmologist have hoped for a better solution to a leaky incicion site, beyond sutures. While Sutures will keep the wound secure, they can be time consuming, which is something that both surgeons and patients dislike.
Since the emergence of ReSure Sealant, which was FDA approved in September of 2013, doctors have had the opportunity to use and evaluate the efficacy of the sealant in real life practices, but time will tell if becomes mainstream among surgeons over the next several years.
How Does ReSure Compare to Sutures in Clear Corneal Incisions?
In the FDA studies that were performed prior to approval, 295 out of 471 patients received ReSure, while the remaining 176 received corneal sutures at the incision site.
According to this study, the ReSure sealant was more effective over the course of a 7 day period. In real life cataract surgery, however, it is not standard practice to place a suture in every patient. It is on the rare occasion that there is aqueous fluid leakage at the end of the case that the use of the ReSure sealant would be necessary.
Since the self sealing clear corneal incision method was developed, the rate of corneal suturing after the Intra-ocular lens implantation has greatly decreased. However, this does not mean that the need for suturing corneal wound sites never occurs.
The approval for use of ReSure Sealant is likely to revolutionize cataract eye surgery, yet again, as there are continuous technological improvements being made every year.
This product can be especially useful to newer surgeons who have not had the years of experience in corneal wound suturing, beyond their training experiences, and for seasoned surgeons as well. The time that it saves is beneficial for both the doctor and the patient.
Another positive effect of using the ReSure sealant is that the patient will not have to return for removal, as with sutures. Overall there is much excitement in the ophthalmic industry over the approval of ReSure.